NDC codes

FDA NDC Directory
Product NDC (as listed)0338-7005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-7005Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0338-7005-06003387005066 BAG in 1 CARTON (0338-7005-06) / 1000 mL in 1 BAG (0338-7005-01)Marketed from Jul 15, 2024

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
Generic name (nonproprietary)
leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, 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/100mLDextrose — 10 g/100mL
Dosage form
Injection
Route
Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020734
Marketing start
Listing expires
Other FDA classes
Amino Acids (Chemical structure)
Identifiers
Product ID 0338-7005_ff41ef10-43c8-4813-9b53-f7f2b9dbb468SPL ID ff41ef10-43c8-4813-9b53-f7f2b9dbb468SPL set ID dccff103-8695-400c-a15d-cc2fd078760aRxCUI 800401, 800405, 800416, 800420, 800434, 800438, 800440, 800444UNII K3Z4F929H6, 8DUH1N11BX, 94ZLA3W45F, GMW67QNF9C, 452VLY9402, AE28F7PNPL, 4QD397987E, OF5P57N2ZX, 47E5O17Y3R, 9DLQ4CIU6V, 04Y7590D77, HG18B9YRS7, IY9XDZ35W2, TE7660XO1C, 42HK56048U, 2ZD004190S
Pharmacologic class
Amino Acid

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.

How CPT relates to drug billing

NDC on a medical claim

N400338700506 followed by a unit qualifier and the quantity

Package 00338-7005-06. 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 is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. CLINIMIX is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX may be used to treat negative nitrogen balance in patients. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020734

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020734
ProductStrengthForm · routeLabelerProduct NDC
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 584 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-0180
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 311 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-7001
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 311 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-1133
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 311 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-7003
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 584 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-0184
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 311 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-1134
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 365 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-1137
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 311 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-7007
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 584 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-0188
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 365 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-1138
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 365 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-7009
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 365 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-7011
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 365 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-7013
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 584 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-0194
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 365 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-7015
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 438 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-0198
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 311 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-1089
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 311 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-1091
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 365 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-1099
Clinimixleucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, serine, tyrosine, dextroseLeucine 365 mg/100mL + 15 more ingredientsInjectionIntravenousBaxter Healthcare Corporation0338-1101

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Clinimix NDC 0338-7005 | Med-Code