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 | 0053614122000536141220 | 1 TUBE in 1 CARTON (0536-1412-20) / 15 g in 1 TUBEMarketed from Feb 20, 2024 | |
| 0536-1412-26 | 0053614122600536141226 | 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.NDC labeler code 0536
- 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.
About NDC 0536-1412
- What is NDC 0536-1412?
- 0536-1412 is the product NDC for Adapalene, Adapalene 1 mg/g gel, listed with the FDA by RUGBY LABORATORIES, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adapalene.
- What is the active ingredient?
- Adapalene.
- Who is the labeler?
- RUGBY LABORATORIES, INC., NDC labeler code 0536. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adapalene?
- 35 other product NDCs are listed under this name. See all Adapalene NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adapalene products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA Corp | 73581-216 | 73581-0216-45 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA CORP | 73581-215 | 73581-0215-45 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Walgreens | 0363-4110 | 00363-4110-0500363-4110-16 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Wal-Mart Stores Inc | 79903-338 | 79903-0338-05 |
| Adapalene | Adapalene 3 mg/g | GelTopical | Alembic Pharmaceuticals Limited | 46708-549 | 46708-0549-1546708-0549-4546708-0549-46 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA Corp | 73581-019 | 73581-0019-06 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Target Corporation | 82442-105 | 82442-0105-01 |
| Adapalene | Adapalene 1 mg/g | GelTopical | RITE AID | 11822-0062 | 11822-0062-01 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Cardinal Health | 70000-0666 | 70000-0666-0170000-0666-02 |
| Adapalene | Adapalene 1 mg/g | GelTopical | The Kroger Co. | 30142-725 | 30142-0725-05 |
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 |
| 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 | YYBA CORP | 73581-214 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Wal-Mart Stores Inc | 79903-338 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Target Corporation | 82442-105 |
| PanOxyladapalene | Adapalene 1 mg/g | GelTopical | CROWN LABORATORIES | 0316-0143 |
| PanOxyladapalene | Adapalene 1 mg/g | GelTopical | CROWN LABORATORIES | 0316-0284 |
| Proactiv MD Adapalene Acne Treatmentadapalene | Adapalene .1 g/100g | GelTopical | Alchemee, LLC | 11410-958 |