Over-the-counter drug · ANDA
Adapalene Gel (Adaplaene) NDC 80861-114
Adapalene .00036 g/g · Gel · Topical · Acne Free LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80861-114-01 | 8086101140180861011401 | 1 g in 1 TUBE (80861-114-01)Marketed from Dec 20, 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 Gel
- Generic name (nonproprietary)
- adaplaene
- Active ingredients
- Adapalene — .00036 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 80861-114_57f499d2-c644-4c58-e063-6394a90a9bafSPL ID 57f499d2-c644-4c58-e063-6394a90a9bafSPL set ID 0ce4684a-4733-e669-e063-6394a90a58c1UNII 1L4806J2QFUPC 0850004234563
- 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
N480861011401followed by a unit qualifier and the quantityPackage 80861-0114-01. 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 80861-114
- What is NDC 80861-114?
- 80861-114 is the product NDC for Adapalene Gel (adaplaene), Adapalene .00036 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 Gel (Adaplaene).
- 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 Gel?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
| Adapaleneadaplane 0.1% | Adapalene .1 g/g | GelTopical | Acne Free, LLC | 80861-115 |
| 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 |