Prescription drug · ANDA
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% NDC 21922-052
Adapalene 1 mg/g; Benzoyl peroxide 25 mg/g · Gel · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-052-50 | 21922005250 | 1 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMPMarketed from Aug 14, 2023 |
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 Gel, 0.1%/2.5%
- Generic name (nonproprietary)
- adapalene and benzoyl peroxide gel, 0.1%/2.5%
- Active ingredients
- Adapalene — 1 mg/gBenzoyl peroxide — 25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206164
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 21922-052_977e8df9-820f-4b8f-bfe2-da1b72ca93c7SPL ID 977e8df9-820f-4b8f-bfe2-da1b72ca93c7SPL set ID 66858a82-cfda-4ba9-aac7-cf65499f4b1aRxCUI 829539UNII 1L4806J2QF, W9WZN9A0GM
- 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
N421922005250followed by a unit qualifier and the quantityPackage 21922-0052-50. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adapalene and benzoyl peroxide gel USP, 0.1% / 2.5% is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206164
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 Peroxide Gel, 0.1%/2.5% | Adapalene 1 mg/g; Benzoyl peroxide 25 mg/g | GelTopical | Bryant Ranch Prepack | 72162-2296 |