Prescription drug · ANDA
Adapalene Gel USP, 0.3% NDC 72162-2295
Adapalene 3 mg/g · Gel · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2295-2 | 72162229502 | 1 TUBE in 1 CARTON (72162-2295-2) / 45 g in 1 TUBEMarketed from Apr 30, 2024 | |
| 72162-2295-4 | 72162229504 | 1 BOTTLE, PUMP in 1 CARTON (72162-2295-4) / 45 g in 1 BOTTLE, PUMPMarketed from Apr 30, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Gel USP, 0.3%
- Generic name (nonproprietary)
- adapalene gel usp, 0.3%
- Active ingredients
- Adapalene — 3 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200298
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 72162-2295_e725e42a-8a28-438f-8476-ce1e54ac33dcSPL ID e725e42a-8a28-438f-8476-ce1e54ac33dcSPL set ID c448eab6-c054-4c8b-9319-556b7e1be3cfRxCUI 722111UNII 1L4806J2QF
- 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
N472162229502followed by a unit qualifier and the quantityPackage 72162-2295-02. 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 Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ADAPALENE Gel, 0.3% is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200298
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 Gel USP, 0.3% | Adapalene 3 mg/g | GelTopical | Encube Ethicals, Inc. | 21922-051 |