Over-the-counter drug · ANDA
Adapalene NDC 72657-158
Adapalene 1 mg/g · Gel · Topical · GLENMARK THERAPEUTICS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72657-158-17 | 72657015817 | 1 TUBE in 1 CARTON (72657-158-17) / 15 g in 1 TUBEMarketed from Mar 10, 2023 | |
| 72657-158-55 | 72657015855 | 1 TUBE in 1 CARTON (72657-158-55) / 45 g in 1 TUBEMarketed from Mar 10, 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
- Generic name (nonproprietary)
- adapalene
- Active ingredients
- Adapalene — 1 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091314
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 72657-158_52ea6426-f743-4a3f-b927-5940f4428593SPL ID 52ea6426-f743-4a3f-b927-5940f4428593SPL set ID 42c1c354-2c00-4bc2-bbd3-a5dd5ff9a208RxCUI 307731UNII 1L4806J2QFUPC 0372657158176, 0372657158558
- 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
N472657015817followed by a unit qualifier and the quantityPackage 72657-0158-17. 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 091314
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 |
|---|---|---|---|---|
| Curist Acne Reliefadapalene | Adapalene .1 g/100g | GelTopical | Little Pharma, Inc. | 72559-015 |
| Adapalene | Adapalene 1 mg/g | GelTopical | TOP CARE (Topco Associates LLC) | 36800-088 |
| Adapalene | Adapalene 1 mg/g | GelTopical | MEIJER, INC. | 41250-288 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Walgreens | 0363-0888 |
| Adapalene Geladaplaene | Adapalene .00036 g/g | GelTopical | Acne Free LLC | 80861-114 |
| Adapaleneadaplane 0.1% | Adapalene .1 g/g | GelTopical | Acne Free, LLC | 80861-115 |
| Adapalene | Adapalene 1 mg/g | GelTopical | CVS Pharmacy | 69842-088 |
| Adapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-354 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA Corp | 73581-216 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-880 |
| Effaclaradapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-591 |
| Effaclaradapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-592 |