Over-the-counter drug · ANDA
Adapalene NDC 51316-114
Adapalene 1 mg/g · Gel · Topical · CVS PHARMACY, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-114-05 | 51316011405 | 1 TUBE in 1 CARTON (51316-114-05) / 15 g in 1 TUBEMarketed from Oct 31, 2023 | |
| 51316-114-16 | 51316011416 | 1 TUBE in 1 CARTON (51316-114-16) / 45 g in 1 TUBEMarketed from Oct 31, 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
- CVS PHARMACY, INC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090962
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 51316-114_9f814bf1-58b8-4438-a8b0-e1c91bfe7deaSPL ID 9f814bf1-58b8-4438-a8b0-e1c91bfe7deaSPL set ID ff9a929e-121b-42b4-8e79-f8f46c22a8beRxCUI 307731UNII 1L4806J2QFUPC 0359726114066
- 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
N451316011405followed by a unit qualifier and the quantityPackage 51316-0114-05. 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 090962
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 Paraben Freeadapalene | Adapalene 1 mg/g | GelTopical | The Kroger Co. | 30142-542 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA CORP | 73581-215 |
| Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatmentadapalene | Adapalene 1 mg/g | GelTopical | Kenvue Brands LLC | 69968-0945 |
| Adapalene | Adapalene 1 mg/g | GelTopical | The Kroger Co. | 30142-725 |
| Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne Treatmentadapalene | Adapalene 1 mg/g | GelTopical | Kenvue Brands LLC | 69968-1004 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Topco Associates | 76162-114 |
| Adapalene Paraben Freeadapalene | Adapalene 1 mg/g | GelTopical | CVS PHARMACY, INC | 51316-219 |
| Adapalene Paraben Freeadapalene | Adapalene 1 mg/g | GelTopical | Topco Associates | 76162-221 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Walgreens | 0363-1401 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Meijer Distribution Inc. | 79481-1140 |
| Adapalene Paraben Freeadapalene | Adapalene 1 mg/g | GelTopical | Meijer Distribution Inc. | 79481-2210 |
| Neutrogena Adapalene 0.1% Acne Treatmentadapalene | Adapalene 1 mg/g | GelTopical | Kenvue Brands LLC | 69968-0826 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Safeway, Inc. | 21130-754 |
| Adapalene | Adapalene 1 mg/g | GelTopical | P & L Development, LLC | 59726-114 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Walgreens | 0363-4110 |