Atralin
- Product NDC
- 13548-070
- 11-digit product format
- 135480070
- Labeler code
- 13548
- Product ID
- 13548-070_77e095d6-f941-44ef-ad04-08d607843d65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Bausch Health US, LLC
- Application
- NDA022070
- Marketing category
- NDA
- Marketing start
- 2007-07-26
- Substance
- TRETINOIN
- Active strength
- .05 g/100g
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atralin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRETINOIN | .05 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5688UTC01R |
| Rxcui | 245723, 749329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13548-070-01 | Atralin | 2 g in 1 TUBE | GEL | 2 | | 10 |
| 13548-070-45 | Atralin | 1 in 1 PACKAGE | GEL | 1 | | 10 |
| 13548-070-45 | Atralin | 45 g in 1 TUBE | GEL | 45 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13548-070 | ATRALIN (TRETINOIN) GEL [BAUSCH HEALTH US, LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240423_b6b45969-a64a-4ce3-b3b6-157d2568a301.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13548-070-01 | 13548007001 | 2 g in 1 TUBE | 2 g | | | | | Historical |
| 13548-070-45 | 13548007045 | 1 TUBE in 1 PACKAGE (13548-070-45) / 45 g in 1 TUBE | 1 tube | 2007-07-26 | 0000-00-00 | No | No | Current |