Prescription drug · ANDA
Tretinoin NDC 0574-2205
Tretinoin .5 mg/g · Cream · Topical · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-2205-20 | 00574220520 | 1 TUBE in 1 CARTON (0574-2205-20) / 20 g in 1 TUBEMarketed from May 5, 2017 | |
| 0574-2205-45 | 00574220545 | 1 TUBE in 1 CARTON (0574-2205-45) / 45 g in 1 TUBEMarketed from Apr 26, 2017 |
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 — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Padagis US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075265
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0574-2205_f7c1542f-286b-449a-86f6-b86f7369c36eSPL ID f7c1542f-286b-449a-86f6-b86f7369c36eSPL set ID 4889c7f8-37d0-4f1a-9829-bca107806586RxCUI 106302, 106303, 198300, 313450, 313451UNII 5688UTC01R
- 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
N400574220520followed by a unit qualifier and the quantityPackage 00574-2205-20. 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 gel and cream are 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 ANDA 075265
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.