Tretinoin
- Product NDC
- 51672-1407
- 11-digit product format
- 516721407
- Labeler code
- 51672
- Product ID
- 51672-1407_3629e80a-923f-b80a-e063-6394a90a44d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tretinoin
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA215713
- Marketing category
- ANDA
- Marketing start
- 2023-01-05
- Substance
- TRETINOIN
- Active strength
- .25 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 | .25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5688UTC01R |
| Rxcui | 106302 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-1407-0 | Tretinoin | 20 g in 1 TUBE | CREAM | 20 | | 6 |
| 51672-1407-0 | Tretinoin | 1 in 1 CARTON | CREAM | 1 | | 6 |
| 51672-1407-9 | Tretinoin | 1 in 1 CARTON | CREAM | 1 | | 6 |
| 51672-1407-9 | Tretinoin | 45 g in 1 TUBE | CREAM | 45 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1407 | TRETINOIN CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20250529_2a31b13b-5cc8-4f6a-b364-872f6a478025.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 |
|---|
| 51672-1407-0 | 51672140700 | 1 TUBE in 1 CARTON (51672-1407-0) / 20 g in 1 TUBE | 1 tube | 2023-01-05 | 0000-00-00 | No | No | Current |
| 51672-1407-9 | 51672140709 | 1 TUBE in 1 CARTON (51672-1407-9) / 45 g in 1 TUBE | 1 tube | 2023-01-05 | 0000-00-00 | No | No | Current |