Tretinoin
- Product NDC
- 0378-8090
- 11-digit product format
- 003788090
- Labeler code
- 0378
- Product ID
- 0378-8090_7f967c10-776a-4b9c-aeda-70276ff2747f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA207955
- Marketing category
- ANDA
- Marketing start
- 2018-11-14
- Substance
- TRETINOIN
- Active strength
- .5 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 | .5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5688UTC01R |
| Rxcui | 245723 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-8090-45 | Tretinoin | 45 g in 1 TUBE | GEL | 45 | | 3 |
| 0378-8090-45 | Tretinoin | 1 in 1 CARTON | GEL | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-8090 | TRETINOIN GEL [MYLAN PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220909_ce5f4f14-5e60-4cc1-bcb3-1fa9b8aa9cd5.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 |
|---|
| 0378-8090-45 | 00378809045 | 1 TUBE in 1 CARTON (0378-8090-45) / 45 g in 1 TUBE | 1 tube | 2018-11-14 | 0000-00-00 | No | No | Current |