Tretinoin
- Product NDC
- 46708-807
- 11-digit product format
- 467080807
- Labeler code
- 46708
- Product ID
- 46708-807_f46af408-0e68-4a78-8928-fc655c54d0c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA217804
- Marketing category
- ANDA
- Marketing start
- 2025-04-25
- 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 | 198300 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-807-20 | Tretinoin | 20 g in 1 TUBE | CREAM | 20 | | 1 |
| 46708-807-20 | Tretinoin | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 46708-807-45 | Tretinoin | 45 g in 1 TUBE | CREAM | 45 | | 1 |
| 46708-807-45 | Tretinoin | 1 in 1 CARTON | CREAM | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-807 | TRETINOIN CREAM [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20250427_7845d60d-7c4c-4854-a417-6d3ea86a710f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-807-20 | 46708080720 | 1 TUBE in 1 CARTON (46708-807-20) / 20 g in 1 TUBE | 1 tube | 2025-04-25 | No | No | Current |
| 46708-807-45 | 46708080745 | 1 TUBE in 1 CARTON (46708-807-45) / 45 g in 1 TUBE | 1 tube | 2025-04-25 | No | No | Current |