Over-the-counter drug · ANDA
Adapalene NDC 0536-1412
Adapalene 1 mg/g · Gel · Topical · RUGBY LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0536-1412-20 | 00536141220 | 1 TUBE in 1 CARTON (0536-1412-20) / 15 g in 1 TUBEMarketed from Feb 20, 2024 | |
| 0536-1412-26 | 00536141226 | 1 TUBE in 1 CARTON (0536-1412-26) / 45 g in 1 TUBEMarketed from Feb 20, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 1 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- RUGBY LABORATORIES, INC.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215940
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0536-1412_53379843-d840-6f9a-e063-6294a90af2aaSPL ID 53379843-d840-6f9a-e063-6294a90af2aaSPL set ID 330bc2b3-e064-4189-9c47-9c5a50aa4ddeRxCUI 307731UNII 1L4806J2QFUPC 0305361412265
- 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
N400536141220followed by a unit qualifier and the quantityPackage 00536-1412-20. 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)
Use For the treatment of acne
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215940
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 | Adapalene 1 mg/g | GelTopical | RITE AID | 11822-0062 |
| Adapalene | Adapalene 1 mg/g | GelTopical | AMERISOURCE BERGEN | 46122-768 |
| PanOxyladapalene | Adapalene 1 mg/g | GelTopical | CROWN LABORATORIES | 0316-0143 |
| Proactiv MD Adapalene Acne Treatmentadapalene | Adapalene .1 g/100g | GelTopical | Alchemee, LLC | 11410-958 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Wal-Mart Stores Inc | 79903-338 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Sun Pharmaceutical Industries, Inc. | 51672-2150 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Cardinal Health | 70000-0666 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA Corp | 73581-019 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Target Corporation | 82442-105 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA CORP | 73581-214 |
| PanOxyladapalene | Adapalene 1 mg/g | GelTopical | CROWN LABORATORIES | 0316-0284 |