Tretinoin (Microsphere)
- Product NDC
- 68308-777
- 11-digit product format
- 683080777
- Labeler code
- 68308
- Product ID
- 68308-777_7c0103a9-019d-4bc4-b4f5-df7d89bfd11d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tretinoin
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Mayne Pharma
- Application
- ANDA215609
- Marketing category
- ANDA
- Marketing start
- 2024-10-25
- Substance
- TRETINOIN
- Active strength
- .8 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 (Microsphere)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRETINOIN | .8 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5688UTC01R |
| Rxcui | 1488045 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68308-777-50 | Tretinoin (Microsphere) | 50 g in 1 BOTTLE, PUMP | GEL | 50 | | 1 |
| 68308-777-50 | Tretinoin (Microsphere) | 1 in 1 CARTON | GEL | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68308-777 | TRETINOIN (MICROSPHERE) (TRETINOIN) GEL [MAYNE PHARMA] | 1 | Current NDC, 2 package rows | 20241030_ed2103ee-c9d5-4b3d-b525-318cf67be050.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68308-777-50 | 68308077750 | 1 BOTTLE, PUMP in 1 CARTON (68308-777-50) / 50 g in 1 BOTTLE, PUMP | 2024-10-25 | No | No | Historical |