Prescription drug · NDA
Acanya NDC 13548-132
clindamycin phosphate and benzoyl peroxide · Clindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/g · Gel · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13548-132-50 | 13548013250 | 1 BOTTLE, PUMP in 1 CARTON (13548-132-50) / 50 g in 1 BOTTLE, PUMPMarketed from Jul 26, 2010 |
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)
- Acanya
- Generic name (nonproprietary)
- clindamycin phosphate and benzoyl peroxide
- Active ingredients
- Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bausch Health US, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050819
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)
- Identifiers
- Product ID 13548-132_110dde63-b7d7-49af-aa96-9daefccb84ffSPL ID 110dde63-b7d7-49af-aa96-9daefccb84ffSPL set ID 3dcd2c96-72b1-4a9f-b65c-08198d63b7dfUNII EH6D7113I8, W9WZN9A0GM
- 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
N413548013250followed by a unit qualifier and the quantityPackage 13548-0132-50. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under NDA 050819
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 |
|---|---|---|---|---|
| Onextonclindamycin phosphate and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/g | GelTopical | Bausch Health US, LLC | 0187-3050 |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-132 |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 37.5 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-133 |