Prescription drug · NDA AUTHORIZED GENERIC
Adapalene NDC 68308-666
Adapalene 3 mg/g · Gel · Topical · Mayne Pharma Commercial LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68308-666-25 | 68308066625 | 1 TUBE in 1 CARTON (68308-666-25) / 45 g in 1 TUBEMarketed from Feb 26, 2024 | |
| 68308-666-45 | 68308066645 | 1 BOTTLE, PUMP in 1 CARTON (68308-666-45) / 45 g in 1 BOTTLE, PUMPMarketed from Feb 26, 2024 |
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
- Generic name (nonproprietary)
- adapalene
- Active ingredients
- Adapalene — 3 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Mayne Pharma Commercial LLC.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021753
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 68308-666_86366747-19bc-4279-8e62-afc7c8682e4bSPL ID 86366747-19bc-4279-8e62-afc7c8682e4bSPL set ID 9a0d9a0d-a9f3-4eb9-be76-166ef182d13aRxCUI 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
N468308066625followed by a unit qualifier and the quantityPackage 68308-0666-25. 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)
Adapalene Gel 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. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021753
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 |
|---|---|---|---|---|
| Differinadapalene | Adapalene 3 mg/g | GelTopical | Galderma Laboratories, L.P. | 0299-5918 |