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 | 7265701581772657015817 | 1 TUBE in 1 CARTON (72657-158-17) / 15 g in 1 TUBEMarketed from Mar 10, 2023 | |
| 72657-158-55 | 7265701585572657015855 | 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
- Labeler
- GLENMARK THERAPEUTICS INC., USANDC labeler code 72657
- 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.
About NDC 72657-158
- What is NDC 72657-158?
- 72657-158 is the product NDC for Adapalene, Adapalene 1 mg/g gel, listed with the FDA by GLENMARK THERAPEUTICS INC., USA. 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?
- GLENMARK THERAPEUTICS INC., USA, NDC labeler code 72657. 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 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 |
|---|---|---|---|---|
| Adapalene | Adapalene 1 mg/g | GelTopical | Walgreens | 0363-0888 |
| Adapalene | Adapalene 1 mg/g | GelTopical | MEIJER, INC. | 41250-288 |
| Adapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-354 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-880 |
| Adapalene | Adapalene 1 mg/g | GelTopical | CVS Pharmacy | 69842-088 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA Corp | 73581-216 |
| Adapaleneadaplane 0.1% | Adapalene .1 g/g | GelTopical | Acne Free, LLC | 80861-115 |
| Adapalene Geladaplaene | Adapalene .00036 g/g | GelTopical | Acne Free LLC | 80861-114 |
| Curist Acne Reliefadapalene | Adapalene .1 g/100g | GelTopical | Little Pharma, Inc. | 72559-015 |
| Effaclaradapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-591 |
| Effaclaradapalene | Adapalene 1 mg/g | GelTopical | LOreal USA Products Inc | 49967-592 |