ACCUTANE
- Product NDC
- 72143-231
- 11-digit product format
- 721430231
- Labeler code
- 72143
- Product ID
- 72143-231_59a3c0bb-8c7f-4a86-96f0-43d85fe6c0a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ISOTRETINOIN
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- JG Pharma Inc.
- Application
- ANDA202099
- Marketing category
- ANDA
- Marketing start
- 2021-01-11
- Marketing end
- 2023-09-30
- Substance
- ISOTRETINOIN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72143-231-30 | 72143023130 | 3 BLISTER PACK in 1 CARTON (72143-231-30) > 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (72143-231-10) | 3 blister pack | 2021-01-11 | 2023-09-30 | No | No | Current |