NDC 55111-113 – Zenatane
Isotretinoin 30 mg/1 · Capsule, Gelatin Coated · Oral
Product NDC55111-113
Product details
- Brand name
- Zenatane
- Generic name
- Isotretinoin
- Labeler
- Dr. Reddy's Laboratories Limited
- Dosage form
- Capsule, Gelatin Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA202099
- Marketed since
- March 9, 2015
- Listing expires
- December 31, 2026
- Pharmacologic class
- Retinoid
Active ingredients
- Isotretinoin 30 mg/1
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 55111-113-78 | 10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) | Mar 9, 2015 |
| 55111-113-81 | 3 BLISTER PACK in 1 CARTON (55111-113-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) | Mar 9, 2015 |
Recalls mentioning this NDC
- D-0883-2017 Jun 14, 2017 · Class II
Failed Dissolution Specifications: out of specification results observed for low dissolution. - D-0885-2017 Jun 14, 2017 · Class II
Failed Dissolution Specifications: out of specification results observed for low dissolution. - D-0884-2017 Jun 14, 2017 · Class II
Failed Dissolution Specifications: out of specification results observed for low dissolution. - D-0886-2017 Jun 14, 2017 · Class II
Failed Dissolution Specifications: out of specification results observed for low dissolution. - D-0509-2017 Mar 8, 2017 · Class III
Failed dissolution specifications - low dissolution results at S3 stage. - D-0507-2017 Mar 8, 2017 · Class III
Failed dissolution specifications - low dissolution results at S3 stage. - D-0506-2017 Mar 8, 2017 · Class III
Failed dissolution specifications - low dissolution results at S3 stage. - D-0098-2017 Oct 19, 2016 · Class III
Failed Dissolution Specifications
Other Zenatane products
- 68001-652 Isotretinoin 10 mg/1 · Capsule, Gelatin Coated · BluePoint Laboratories
- 68001-653 Isotretinoin 20 mg/1 · Capsule, Gelatin Coated · BluePoint Laboratories
- 68001-654 Isotretinoin 30 mg/1 · Capsule, Gelatin Coated · BluePoint Laboratories
- 68001-655 Isotretinoin 40 mg/1 · Capsule, Gelatin Coated · BluePoint Laboratories
- 55111-135 Isotretinoin 10 mg/1 · Capsule, Gelatin Coated · Dr. Reddy's Laboratories Limited
- 55111-136 Isotretinoin 20 mg/1 · Capsule, Gelatin Coated · Dr. Reddy's Laboratories Limited
- 55111-137 Isotretinoin 40 mg/1 · Capsule, Gelatin Coated · Dr. Reddy's Laboratories Limited