Prescription drug · ANDA
Clindamycin Phosphate NDC 63629-8631
Clindamycin phosphate 10 mg/g · Gel · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8631-1 | 63629863101 | 1 TUBE in 1 CARTON (63629-8631-1) / 60 g in 1 TUBEMarketed from Jan 20, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212104
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 63629-8631_00b610eb-ba17-de05-e063-6294a90aa7caSPL ID 00b610eb-ba17-de05-e063-6294a90aa7caSPL set ID bdfa283e-87ca-41bd-9ae1-d6652dcfa7ddRxCUI 2676585UNII 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
N463629863101followed by a unit qualifier and the quantityPackage 63629-8631-01. 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 212104
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 | Padagis Israel Pharmaceuticals Ltd | 45802-900 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Bryant Ranch Prepack | 72162-1436 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Bryant Ranch Prepack | 63629-8630 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/g | GelTopical | Bryant Ranch Prepack | 63629-9309 |