Prescription drug · ANDA
Clindamycin Phosphate (Clindamycin phosphate topical) NDC 80005-131
Clindamycin phosphate 10 mg/mL · Solution · Topical · Carnegie Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80005-131-09 | 8000501310980005013109 | 60 APPLICATOR in 1 JAR (80005-131-09) / 1 mL in 1 APPLICATORMarketed from Jun 16, 2025 | |
| 80005-131-38 | 8000501313880005013138 | 69 APPLICATOR in 1 JAR (80005-131-38) / 1 mL in 1 APPLICATORMarketed from Dec 15, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 topical
- Active ingredients
- Clindamycin phosphate — 10 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Carnegie Pharmaceuticals, LLCNDC labeler code 80005
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219612
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 80005-131_afc7cc5c-76c8-4807-82c2-765f51bdacd3SPL ID afc7cc5c-76c8-4807-82c2-765f51bdacd3SPL set ID c8fe61f1-f3c5-4452-9980-a727461b9844RxCUI 309333UNII 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480005013109followed by a unit qualifier and the quantityPackage 80005-0131-09. 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)
INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).
Excerpt only. Read the full label for complete information.
About NDC 80005-131
- What is NDC 80005-131?
- 80005-131 is the product NDC for Clindamycin Phosphate (clindamycin phosphate topical), Clindamycin phosphate 10 mg/mL solution, listed with the FDA by Carnegie Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin Phosphate (Clindamycin Phosphate Topical).
- What is the active ingredient?
- Clindamycin phosphate.
- Who is the labeler?
- Carnegie Pharmaceuticals, LLC, NDC labeler code 80005. 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 | 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 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Zydus Lifesciences Limited | 70771-1855 | 70771-1855-0270771-1855-03 |