Prescription drug · ANDA
Clindamycin (Clindamycin phosphate) NDC 0404-9838
Clindamycin phosphate 150 mg/mL · Injection, Solution · Intramuscular, Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9838-04 | 0040498380400404983804 | 1 VIAL in 1 BAG (0404-9838-04) / 4 mL in 1 VIALMarketed from Jan 9, 2022 |
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
- Generic name (nonproprietary)
- clindamycin phosphate
- Active ingredients
- Clindamycin phosphate — 150 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090108
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 0404-9838_818d5172-0214-4204-b2e6-6266ce15e8e6SPL ID 818d5172-0214-4204-b2e6-6266ce15e8e6SPL set ID 8a4e2ba4-90e6-48e8-a943-0c5d3f169780RxCUI 1737244, 1737578, 1737581UNII 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
N400404983804followed by a unit qualifier and the quantityPackage 00404-9838-04. 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 is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection, USP is 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 antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.…
Excerpt only. Read the full label for complete information.
About NDC 0404-9838
- What is NDC 0404-9838?
- 0404-9838 is the product NDC for Clindamycin (clindamycin phosphate), Clindamycin phosphate 150 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin (Clindamycin Phosphate).
- What is the active ingredient?
- Clindamycin phosphate.
- Who is the labeler?
- Henry Schein, Inc., NDC labeler code 0404. 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?
- 5 other product NDCs are listed under this name. See all Clindamycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-115 | 25021-0115-0225021-0115-0425021-0115-06 |
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7191 | 71872-7191-01 |
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7192 | 71872-7192-01 |
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7199 | 71872-7199-01 |
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7284 | 71872-7284-01 |
Other NDCs under ANDA 090108
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 |
|---|---|---|---|---|
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntramuscular, Intravenous | Sagent Pharmaceuticals | 25021-115 |
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7191 |
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7192 |
| Clindamycinclindamycin phosphate | Clindamycin phosphate 150 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7284 |