Prescription drug · ANDA
Clindamycin Phoaphate Topical Solution USP, 1% NDC 72603-321
clindamycin phosphate topical solution usp, 1% · Clindamycin phosphate 10 mg/mL · Solution · Topical · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-321-01 | 7260303210172603032101 | 1 BOTTLE in 1 CARTON (72603-321-01) / 30 mL in 1 BOTTLEMarketed from Nov 14, 2024 | |
| 72603-321-02 | 7260303210272603032102 | 1 BOTTLE in 1 CARTON (72603-321-02) / 60 mL in 1 BOTTLEMarketed from Nov 14, 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 Phoaphate Topical Solution USP, 1%
- Generic name (nonproprietary)
- clindamycin phosphate topical solution usp, 1%
- Active ingredients
- Clindamycin phosphate — 10 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Northstar Rx LLCNDC labeler code 72603
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209914
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 72603-321_407f6d80-7de0-45d9-8ad2-5b95d233b96dSPL ID 407f6d80-7de0-45d9-8ad2-5b95d233b96dSPL set ID 407f6d80-7de0-45d9-8ad2-5b95d233b96dRxCUI 309333UNII EH6D7113I8UPC 0372603321012, 0372603321029
- 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
N472603032101followed by a unit qualifier and the quantityPackage 72603-0321-01. 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 topical solution USP, 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.
About NDC 72603-321
- What is NDC 72603-321?
- 72603-321 is the product NDC for Clindamycin Phoaphate Topical Solution USP, 1%, Clindamycin phosphate 10 mg/mL solution, listed with the FDA by Northstar Rx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin Phoaphate Topical Solution USP, 1% (Clindamycin Phosphate Topical Solution USP, 1%).
- What is the active ingredient?
- Clindamycin phosphate.
- Who is the labeler?
- Northstar Rx LLC, NDC labeler code 72603. 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 Phoaphate Topical Solution USP, 1%?
- 1 other product NDC are listed under this name. See all Clindamycin Phoaphate Topical Solution USP, 1% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin Phoaphate Topical Solution USP, 1% 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 Phoaphate Topical Solution USP, 1%clindamycin phosphate topical solution usp, 1% | Clindamycin phosphate 10 mg/mL | SolutionTopical | Encube Ethicals, Inc. | 21922-002 | 21922-0002-0121922-0002-21 |
Other NDCs under ANDA 209914
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 Phoaphate Topical Solution USP, 1%clindamycin phosphate topical solution usp, 1% | Clindamycin phosphate 10 mg/mL | SolutionTopical | Encube Ethicals, Inc. | 21922-002 |
| Clindamycin Phoaphate Topical USP, 1%clindamycin phosphate topical usp, 1% | Clindamycin phosphate 10 mg/mL | SolutionTopical | A-S Medication Solutions | 50090-6592 |