Over-the-counter drug · ANDA
Adapalene (Adaplane 0.1%) NDC 80861-115
Adapalene .1 g/g · Gel · Topical · Acne Free, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80861-115-01 | 8086101150180861011501 | 1 g in 1 TUBE (80861-115-01)Marketed from Jan 5, 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)
- adaplane 0.1%
- Active ingredients
- Adapalene — .1 g/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Acne Free, LLCNDC labeler code 80861
- 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 80861-115_57f48a0b-5424-3b28-e063-6294a90accd6SPL ID 57f48a0b-5424-3b28-e063-6294a90accd6SPL set ID 0dc574e0-397a-7bc8-e063-6394a90a27e2UNII 1L4806J2QFUPC 0850039795091
- 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
N480861011501followed by a unit qualifier and the quantityPackage 80861-0115-01. 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 80861-115
- What is NDC 80861-115?
- 80861-115 is the product NDC for Adapalene (adaplane 0.1%), Adapalene .1 g/g gel, listed with the FDA by Acne Free, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adapalene (Adaplane 0.1%).
- What is the active ingredient?
- Adapalene.
- Who is the labeler?
- Acne Free, LLC, NDC labeler code 80861. 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 | GLENMARK THERAPEUTICS INC., USA | 72657-158 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA Corp | 73581-216 |
| 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 |