Prescription drug · ANDA
Clindamycin Phosphate NDC 62135-478
Clindamycin phosphate 10 mg/mL · Solution · Topical · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-478-30 | 62135047830 | 30 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-30)Marketed from Aug 28, 2025 | |
| 62135-478-60 | 62135047860 | 60 mL in 1 BOTTLE, WITH APPLICATOR (62135-478-60)Marketed from Aug 28, 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
- Active ingredients
- Clindamycin phosphate — 10 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209846
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 62135-478_3e0d9a3b-5c3d-e0b5-e063-6394a90a2980SPL ID 3e0d9a3b-5c3d-e0b5-e063-6394a90a2980SPL set ID 7740ed35-ff93-4c5e-8983-934ff7b86da7RxCUI 309333UNII EH6D7113I8UPC 0362135478605
- 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
N462135047830followed by a unit qualifier and the quantityPackage 62135-0478-30. 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 Topical Solution, 1% 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 209846
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 11.9 mg/mL | SolutionTopical | A-S Medication Solutions | 50090-5779 |