TRETINOIN
- Product NDC
- 21922-043
- 11-digit product format
- 219220043
- Labeler code
- 21922
- Product ID
- 21922-043_8cc4690a-be86-4f4a-8bd1-ff9f5d5d5747
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tretinoin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA215609
- Marketing category
- ANDA
- Marketing start
- 2023-08-24
- Substance
- TRETINOIN
- Active strength
- .8 mg/g
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRETINOIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRETINOIN | .8 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5688UTC01R |
| Rxcui | 1488045, 1987644 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21922-043-40 | TRETINOIN | 50 g in 1 BOTTLE, PUMP | GEL | 50 | | 5 |
| 21922-043-40 | TRETINOIN | 1 in 1 CARTON | GEL | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-043 | TRETINOIN GEL [ENCUBE ETHICALS PRIVATE LIMITED] | 3 | Current NDC, 2 package rows | 20230824_57558405-42fa-40bb-a61c-48e030d976de.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 21922-043-40 | 21922004340 | 1 BOTTLE, PUMP in 1 CARTON (21922-043-40) / 50 g in 1 BOTTLE, PUMP | 2023-08-24 | No | No | Current |