Over-the-counter drug · ANDA
PanOxyl (Adapalene) NDC 0316-0143
Adapalene 1 mg/g · Gel · Topical · CROWN LABORATORIES
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0316-0143-15 | 0031601431500316014315 | 1 TUBE in 1 CARTON (0316-0143-15) / 15 g in 1 TUBEMarketed from Feb 6, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- PanOxyl
- Generic name (nonproprietary)
- adapalene
- Active ingredients
- Adapalene — 1 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- CROWN LABORATORIESNDC labeler code 0316
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215940
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0316-0143_38f58d6b-acd6-e391-e063-6294a90a5d10SPL ID 38f58d6b-acd6-e391-e063-6294a90a5d10SPL set ID 40f8d9e1-d1b9-464b-92ba-9695d419a6f7RxCUI 307731UNII 1L4806J2QFUPC 0303160143151
- 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
N400316014315followed by a unit qualifier and the quantityPackage 00316-0143-15. 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 0316-0143
- What is NDC 0316-0143?
- 0316-0143 is the product NDC for PanOxyl (adapalene), Adapalene 1 mg/g gel, listed with the FDA by CROWN LABORATORIES. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PanOxyl (Adapalene).
- What is the active ingredient?
- Adapalene.
- Who is the labeler?
- CROWN LABORATORIES, NDC labeler code 0316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PanOxyl?
- 5 other product NDCs are listed under this name. See all PanOxyl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other PanOxyl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| PanOxylsalicylic acid | Salicylic acid 20 mg/g | SoapTopical | Crown Laboratories | 0316-0288 | 00316-0288-01 |
| PanOxyladapalene | Adapalene 1 mg/g | GelTopical | CROWN LABORATORIES | 0316-0284 | 00316-0284-15 |
| PanOxylbenzoyl peroxide | Benzoyl peroxide 12.6 g/113g | SoapTopical | Crown Laboratories | 0316-0264 | 00316-0264-0100316-0264-04 |
| PanOxylbenzoyl peroxide | Benzoyl peroxide 58.7 mg/g | CreamTopical | Crown Laboratories | 0316-0227 | 00316-0227-06 |
| PanOxylbenzoyl peroxide | Benzoyl peroxide 100 mg/g | CreamTopical | Crown Laboratories | 0316-0228 | 00316-0228-0100316-0228-0300316-0228-55 |
Other NDCs under ANDA 215940
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 | RUGBY LABORATORIES, INC. | 0536-1412 |
| Adapalene | Adapalene 1 mg/g | GelTopical | RITE AID | 11822-0062 |
| Adapalene | Adapalene 1 mg/g | GelTopical | AMERISOURCE BERGEN | 46122-768 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Sun Pharmaceutical Industries, Inc. | 51672-2150 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Cardinal Health | 70000-0666 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA Corp | 73581-019 |
| Adapalene | Adapalene 1 mg/g | GelTopical | YYBA CORP | 73581-214 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Wal-Mart Stores Inc | 79903-338 |
| Adapalene | Adapalene 1 mg/g | GelTopical | Target Corporation | 82442-105 |
| PanOxyladapalene | Adapalene 1 mg/g | GelTopical | CROWN LABORATORIES | 0316-0284 |
| Proactiv MD Adapalene Acne Treatmentadapalene | Adapalene .1 g/100g | GelTopical | Alchemee, LLC | 11410-958 |