Prescription drug · ANDA
Clindacin (clindamycin phosphate) NDC 43538-179
Clindamycin phosphate 10 mg/g · Aerosol, Foam · Topical · Medimetriks Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43538-179-10 | 43538017910 | 1 CAN in 1 CARTON (43538-179-10) / 100 g in 1 CANMarketed from Nov 14, 2022 |
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)
- Clindacin
- Generic name (nonproprietary)
- clindamycin phosphate
- Active ingredients
- Clindamycin phosphate — 10 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090785
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 43538-179_391b4472-8468-4d6f-bab0-406d83655cd0SPL ID 391b4472-8468-4d6f-bab0-406d83655cd0SPL set ID d01ffda3-1913-400d-a899-58b8face8936RxCUI 477451, 2621717UNII 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
N443538017910followed by a unit qualifier and the quantityPackage 43538-0179-10. 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)
Clindacin ® (clindamycin phosphate) Foam, 1% is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. Clindacin Foam is a lincosamide product indicated for acne vulgaris in patients 12 years and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090785
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 10 mg/g | Aerosol, FoamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-660 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | Aerosol, FoamTopical | Bryant Ranch Prepack | 63629-8628 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | Aerosol, FoamTopical | Bryant Ranch Prepack | 63629-8629 |