Prescription drug · ANDA
Adapalene NDC 0168-0424
Adapalene 1 mg/g · Cream · Topical · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0424-46 | 0016804244600168042446 | 1 TUBE in 1 CARTON (0168-0424-46) / 45 g in 1 TUBEMarketed from Jun 30, 2010 |
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)
- Adapalene
- Generic name (nonproprietary)
- adapalene
- Active ingredients
- Adapalene — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNDC labeler code 0168
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090824
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0168-0424_3704e230-6ad8-448d-a4bf-a86c449837b9SPL ID 3704e230-6ad8-448d-a4bf-a86c449837b9SPL set ID 276f7cce-5f54-40f8-8321-9192d0e52a73RxCUI 313852UNII 1L4806J2QFUPC 0301680424460
- 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
N400168042446followed by a unit qualifier and the quantityPackage 00168-0424-46. 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)
INDICATIONS AND USAGE: Adapalene cream is indicated for the topical treatment of acne vulgaris.
Excerpt only. Read the full label for complete information.
About NDC 0168-0424
- What is NDC 0168-0424?
- 0168-0424 is the product NDC for Adapalene, Adapalene 1 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 1 package NDC, 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?
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. 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 090824
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 | CreamTopical | Bryant Ranch Prepack | 63629-8791 |
| Adapalene | Adapalene 1 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1048 |