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 | 00168042446 | 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
- 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.
Other NDCs under ANDA 090824
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.