Prescription drug · ANDA
Adapalene And Benzoyl Peroxide NDC 46708-662
adapalene and benzoyl peroxide topical · Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g · Gel · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-662-45 | 46708066245 | 1 BOTTLE, PUMP in 1 CARTON (46708-662-45) / 45 g in 1 BOTTLE, PUMPMarketed from May 21, 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)
- Adapalene And Benzoyl Peroxide
- Generic name (nonproprietary)
- adapalene and benzoyl peroxide topical
- Active ingredients
- Adapalene — 3 mg/gBenzoyl peroxide — 25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214185
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 46708-662_528fc681-2ba1-442f-812f-339f90b0a030SPL ID 528fc681-2ba1-442f-812f-339f90b0a030SPL set ID 2d4e5111-4f9f-42dd-8cf7-56bdc51fbbadRxCUI 1663745UNII 1L4806J2QF, W9WZN9A0GMUPC 0362332662456
- Pharmacologic class
- Retinoid
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
N446708066245followed by a unit qualifier and the quantityPackage 46708-0662-45. 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)
Adapalene and benzoyl peroxide topical gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Adapalene and benzoyl peroxide topical gel, is a combination of adapalene, a retinoid, and benzoyl peroxide and is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214185
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 |
|---|---|---|---|---|
| Adapalene And Benzoyl Peroxideadapalene and benzoyl peroxide topical | Adapalene 3 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Alembic Pharmaceuticals Inc. | 62332-662 |
- openFDA data updated
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