TRETINOIN
- Product NDC
- 0574-2301
- 11-digit product format
- 005742301
- Labeler code
- 0574
- Product ID
- 0574-2301_a25193b8-414f-4dfc-8ddc-8c5f92758279
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tretinoin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Padagis US LLC
- Application
- ANDA075589
- Marketing category
- ANDA
- Marketing start
- 2017-03-30
- Substance
- TRETINOIN
- Active strength
- .1 mg/g
- 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
- TRETINOIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRETINOIN | .1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5688UTC01R |
| Rxcui | 106302, 106303, 198300, 313450, 313451 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0574-2301 | TRETINOIN GEL TRETINOIN CREAM [PADAGIS US LLC] | 18 | Current NDC, Legacy NDC, 4 package rows | 20250202_4889c7f8-37d0-4f1a-9829-bca107806586.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 |
|---|
| 0574-2301-15 | 00574230115 | 1 TUBE in 1 CARTON (0574-2301-15) / 15 g in 1 TUBE | 1 tube | 2017-07-28 | 0000-00-00 | No | No | Current |
| 0574-2301-45 | 00574230145 | 1 TUBE in 1 CARTON (0574-2301-45) / 45 g in 1 TUBE | 1 tube | 2017-03-30 | 0000-00-00 | No | No | Current |