Prescription drug · NDA
Atralin (tretinoin) NDC 13548-070
Tretinoin .05 g/100g · Gel · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13548-070-45 | 13548007045 | 1 TUBE in 1 PACKAGE (13548-070-45) / 45 g in 1 TUBEMarketed from Jul 26, 2007 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Atralin
- Generic name (nonproprietary)
- tretinoin
- Active ingredients
- Tretinoin — .05 g/100g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bausch Health US, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022070
- Marketing start
- Listing expires
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 13548-070_77e095d6-f941-44ef-ad04-08d607843d65SPL ID 77e095d6-f941-44ef-ad04-08d607843d65SPL set ID b6b45969-a64a-4ce3-b3b6-157d2568a301RxCUI 245723, 749329UNII 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
N413548007045followed by a unit qualifier and the quantityPackage 13548-0070-45. 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)
Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022070
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.