Tretinoin
- Product NDC
- 0378-8085
- 11-digit product format
- 003788085
- Labeler code
- 0378
- Product ID
- 0378-8085_96edaee2-b74e-4f7b-947f-1addc75402ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA017955
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-08-12
- 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 |
|---|
| 0378-8085 | TRETINOIN CREAM TRETINOIN GEL [MYLAN PHARMACEUTICALS INC.] | 15 | Current NDC, Legacy NDC, 4 package rows | 20241011_ba377a5e-e48a-4bd9-9d76-929d70793396.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 |
|---|
| 0378-8085-15 | 00378808515 | 1 TUBE in 1 CARTON (0378-8085-15) / 15 g in 1 TUBE | 1 tube | 2019-08-12 | 0000-00-00 | No | No | Current |
| 0378-8085-45 | 00378808545 | 1 TUBE in 1 CARTON (0378-8085-45) / 45 g in 1 TUBE | 1 tube | 2019-08-12 | 0000-00-00 | No | No | Current |