Prescription drug · ANDA
clindamycin and benzoyl peroxide NDC 16714-984
Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g · Gel · Topical · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-984-25 | 16714098425 | 1 JAR in 1 CARTON (16714-984-25) / 25 g in 1 JARMarketed from Jul 1, 2019 | |
| 16714-984-50 | 16714098450 | 1 JAR in 1 CARTON (16714-984-50) / 50 g in 1 JARMarketed from Jul 1, 2019 |
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 and benzoyl peroxide
- Generic name (nonproprietary)
- clindamycin and benzoyl peroxide
- Active ingredients
- Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 50 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209252
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 16714-984_35611701-add1-42d0-9fc2-58368001602aSPL ID 35611701-add1-42d0-9fc2-58368001602aSPL set ID e19de12c-f29b-42ab-9e81-1af8e4a66643RxCUI 358917UNII EH6D7113I8, W9WZN9A0GMUPC 0316714984254, 0316714982021
- 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
N416714098425followed by a unit qualifier and the quantityPackage 16714-0984-25. 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 and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209252
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 and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Glenmark Pharmaceuticals Inc., USA | 68462-486 |
| clindamycin and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Glenmark Pharmaceuticals Inc., USA | 68462-859 |