Prescription drug · ANDA
Clindamycin phosphate NDC 0338-4114
Clindamycin phosphate 900 mg/50mL · Injection, Solution · Intravenous · Baxter Healthcare Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-4114-24 | 0033841142400338411424 | 24 BAG in 1 CASE (0338-4114-24) / 50 mL in 1 BAG (0338-4114-50)Marketed from Aug 9, 2018 |
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)
- Clindamycin phosphate
- Generic name (nonproprietary)
- clindamycin phosphate
- Active ingredients
- Clindamycin phosphate — 900 mg/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CompanyNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208084
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 0338-4114_f578b16a-78b1-443f-b96a-e595ad9e145aSPL ID f578b16a-78b1-443f-b96a-e595ad9e145aSPL set ID 406534a6-2234-4735-ba8f-7de4c87592e6RxCUI 309335, 309336UNII EH6D7113I8
- Pharmacologic class
- Lincosamide Antibacterial
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
N400338411424followed by a unit qualifier and the quantityPackage 00338-4114-24. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Clindamycin Injection USP in 5% Dextrose products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection USP in 5% Dextrose products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial drug-associated pseudomembranous colitis, as described in the BOXED WARNING , before selecting clindamycin the physician should consider the nature of the infe…
Excerpt only. Read the full label for complete information.
About NDC 0338-4114
- What is NDC 0338-4114?
- 0338-4114 is the product NDC for Clindamycin phosphate, Clindamycin phosphate 900 mg/50mL injection, solution, listed with the FDA by Baxter Healthcare Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin phosphate.
- What is the active ingredient?
- Clindamycin phosphate.
- Who is the labeler?
- Baxter Healthcare Company, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clindamycin phosphate?
- 70 other product NDCs are listed under this name. See all Clindamycin phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/mL | SolutionTopical | Rising Pharma Holdings, Inc. | 16571-256 | 16571-0256-6016571-0256-69 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Aurobindo Pharma Limited | 59651-806 | 59651-0806-3059651-0806-60 |
| Clindamycin Phosphateclindamycin phosphate topical | Clindamycin phosphate 10 mg/mL | SolutionTopical | Carnegie Pharmaceuticals, LLC | 80005-131 | 80005-0131-0980005-0131-38 |
| Clindamycin phosphateclindamycin phosphate topical | Clindamycin phosphate 10 mg/mL | SolutionTopical | i3 Pharmaceuticals, LLC | 72319-696 | 72319-0696-60 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Solaris Pharma Corporation | 73473-300 | 73473-0300-3073473-0300-60 |
| Clindamycin Phosphate | Clindamycin phosphate 1 g/10mL | GelTopical | Solaris Pharma Corporation | 73473-302 | 73473-0302-75 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Alembic Pharmaceuticals Limited | 46708-623 | 46708-0623-3046708-0623-60 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Alembic Pharmaceuticals Inc. | 62332-623 | 62332-0623-3062332-0623-60 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | Aerosol, FoamTopical | GLENMARK PHARMACEUTICALS INC., USA | 68462-605 | 68462-0605-2768462-0605-94 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Viona Pharmaceuticals Inc | 72578-118 | 72578-0118-0172578-0118-02 |
Other NDCs under ANDA 208084
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 |
|---|---|---|---|---|
| Clindamycin phosphate | Clindamycin phosphate 300 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-3410 |
| Clindamycin phosphate | Clindamycin phosphate 600 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-3612 |
| Clindamycin phosphate | Clindamycin phosphate 600 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-3616 |
| Clindamycin phosphate | Clindamycin phosphate 900 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Company | 0338-3814 |
| Clindamycin phosphate | Clindamycin phosphate 600 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-993 |
| Clindamycin phosphate | Clindamycin phosphate 900 mg/50mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-995 |