ZENATANE
- Product NDC
- 68001-652
- 11-digit product format
- 680010652
- Labeler code
- 68001
- Product ID
- 68001-652_4e69c221-c1ba-9b55-e063-6394a90afbd4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOTRETINOIN
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA202099
- Marketing category
- ANDA
- Marketing start
- 2025-12-30
- Substance
- ISOTRETINOIN
- Active strength
- 10 mg/1
- 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
- ZENATANE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOTRETINOIN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH28UP18IF |
| Rxcui | 197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68001-652-16 | ZENATANE | 10 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 10 | | 4 |
| 68001-652-17 | ZENATANE | 3 in 1 CARTON | CAPSULE, GELATIN COATED | 3 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68001-652-16 | 68001065216 | 10 in 1 BLISTER PACK | | | | | Historical |
| 68001-652-17 | 68001065217 | 3 BLISTER PACK in 1 CARTON (68001-652-17) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68001-652-16) | 3 blister pack | 2025-12-30 | No | No | Historical |