Prescription drug · ANDA
Clindamycin Phosphate NDC 46708-623
Clindamycin phosphate 10 mg/g · Gel · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-623-30 | 46708062330 | 1 TUBE in 1 CARTON (46708-623-30) / 30 g in 1 TUBEMarketed from Apr 4, 2024 | |
| 46708-623-60 | 46708062360 | 1 TUBE in 1 CARTON (46708-623-60) / 60 g in 1 TUBEMarketed from Apr 4, 2024 |
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
- Active ingredients
- Clindamycin phosphate — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212466
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 46708-623_55359ba6-067b-4e97-8c13-ae3f8dbac818SPL ID 55359ba6-067b-4e97-8c13-ae3f8dbac818SPL set ID 41ab7061-7c3a-4a4c-9c44-16851c97ad00RxCUI 2676585UNII EH6D7113I8UPC 0346708623302
- 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
N446708062330followed by a unit qualifier and the quantityPackage 46708-0623-30. 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 gel 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.
Other NDCs under ANDA 212466
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 | GelTopical | Alembic Pharmaceuticals Inc. | 62332-623 |