Prescription drug · NDA AUTHORIZED GENERIC
Tretinoin NDC 0378-8086
Tretinoin .25 mg/g · Gel · Topical · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-8086-15 | 00378808615 | 1 TUBE in 1 CARTON (0378-8086-15) / 15 g in 1 TUBEMarketed from Jul 12, 2019 | |
| 0378-8086-45 | 00378808645 | 1 TUBE in 1 CARTON (0378-8086-45) / 45 g in 1 TUBEMarketed from Jul 25, 2019 |
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)
- Tretinoin
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — .25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 017579
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0378-8086_96edaee2-b74e-4f7b-947f-1addc75402eaSPL ID 96edaee2-b74e-4f7b-947f-1addc75402eaSPL set ID ba377a5e-e48a-4bd9-9d76-929d70793396RxCUI 106302, 106303, 198300, 313450, 313451UNII 5688UTC01RUPC 0303788082450, 0303788083457, 0303788086151
- 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
N400378808615followed by a unit qualifier and the quantityPackage 00378-8086-15. 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)
Indications and Usage Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 017579
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.