NDC 0378-6611 – Amnesteem
Isotretinoin 10 mg/1 · Capsule · Oral
Product NDC0378-6611
Product details
- Brand name
- Amnesteem
- Generic name
- Isotretinoin
- Labeler
- Mylan Pharmaceuticals Inc.
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- ANDA · ANDA075945
- Marketed since
- November 11, 2002
- Listing expires
- December 31, 2027
- Pharmacologic class
- Retinoid
Active ingredients
- Isotretinoin 10 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0378-6611-93 | 3 BLISTER PACK in 1 CARTON (0378-6611-93) / 10 CAPSULE in 1 BLISTER PACK (0378-6611-85) | Nov 11, 2002 |
Recalls mentioning this NDC
- D-0399-2026 Mar 11, 2026 · Class II
Failed Dissolution Specifications