Prescription drug · NDA
Clinimix E NDC 0338-1144
Leucine 311 mg/100mL + 20 more ingredients · Injection · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-1144-03 | 00338114403 | 1000 mL in 1 BAG (0338-1144-03)Marketed from Mar 26, 1997 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Clinimix E
- Generic name (nonproprietary)
- leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose
- Active ingredients
- Leucine — 311 mg/100mLPhenylalanine — 238 mg/100mLLysine — 247 mg/100mLMethionine — 170 mg/100mLIsoleucine — 255 mg/100mLValine — 247 mg/100mLHistidine — 204 mg/100mLThreonine — 179 mg/100mLTryptophan — 77 mg/100mLAlanine — 880 mg/100mLGlycine — 438 mg/100mLArginine — 489 mg/100mLProline — 289 mg/100mLSerine — 213 mg/100mLTyrosine — 17 mg/100mLSodium acetate — 297 mg/100mLPotassium phosphate, Dibasic — 261 mg/100mLMagnesium chloride — 51 mg/100mLSodium chloride — 77 mg/100mLCalcium chloride — 33 mg/100mLDextrose — 5 g/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Baxter Healthcare Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020678
- Marketing start
- Listing expires
- Other FDA classes
- Amino Acids (Chemical structure)Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Phosphate Chelating Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 0338-1144_c5f1da6b-9b01-4814-97a5-3d7efbedec9cSPL ID c5f1da6b-9b01-4814-97a5-3d7efbedec9cSPL set ID 8469d6fb-d6ef-476f-8cc3-0905192de0a8RxCUI 800998, 801000, 801010, 801012, 801019, 801021, 801029, 801031, 1090635, 1090639UNII AE28F7PNPL, 4QD397987E, 04Y7590D77, 451W47IQ8X, 02F3473H9O, OF5P57N2ZX, TE7660XO1C, GMW67QNF9C, 8DUH1N11BX, 94ZLA3W45F, 47E5O17Y3R, 4550K0SC9B, IY9XDZ35W2, K3Z4F929H6, HG18B9YRS7, 42HK56048U, 452VLY9402, 2ZD004190S, M4I0D6VV5M, 9DLQ4CIU6V, CI71S98N1Z
- Pharmacologic class
- Amino Acid; Blood Coagulation Factor; Calculi Dissolution Agent; Osmotic Laxative; Phosphate Binder
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400338114403followed by a unit qualifier and the quantityPackage 00338-1144-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020678
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 365 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-1125 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 201 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-1142 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 311 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-1145 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 201 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7020 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 365 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-1147 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 365 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-1148 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 311 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7022 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 584 mg/100mL + 19 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-0202 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 311 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7024 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 584 mg/100mL + 19 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-0206 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 311 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7026 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 311 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7028 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 365 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7030 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 584 mg/100mL + 19 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-0210 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 365 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7032 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 584 mg/100mL + 19 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-0214 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 365 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7034 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 365 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-7036 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 311 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-1113 |
| Clinimix Eleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, sodium acetate, dibasic potassium phosphate, magnesium chloride, sodium chloride, calcium chloride, dextrose | Leucine 311 mg/100mL + 20 more ingredients | InjectionIntravenous | Baxter Healthcare Company | 0338-1115 |
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