NDC 0591-0398 – Diclofenac Sodium and Misoprostol
Diclofenac Sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · Oral
Product NDC0591-0398
Product details
- Brand name
- Diclofenac Sodium and Misoprostol
- Generic name
- Diclofenac Sodium and Misoprostol
- Labeler
- Actavis Pharma, Inc.
- Dosage form
- Tablet, Delayed Release
- Route
- Oral
- Marketing category
- ANDA · ANDA201089
- Marketed since
- November 1, 2012
- Listing expires
- December 31, 2027
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; Prostaglandin E1 Analog
Active ingredients
- Diclofenac Sodium 75 mg/1
- Misoprostol 200 ug/1
Uses, dosage, side effects and warnings for Diclofenac sodium and Misoprostol →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0591-0398-60 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0398-60) | Nov 1, 2012 |
Recalls mentioning this NDC
- D-0258-2015 Dec 3, 2014 · Class II
Failed Tablet/Capsule Specifications: Presence of split or broken tablets. - D-1616-2014 Oct 8, 2014 · Class II
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. - D-1617-2014 Oct 8, 2014 · Class II
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. - D-1082-2014 Feb 19, 2014 · Class II
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples. - D-1060-2014 Feb 12, 2014 · Class II
Failed Tablet/Capsule Specifications: Broken tablets - D-817-2013 Jul 31, 2013 · Class II
Failed Tablet/Capsule Specifications: Broken tablets
Other Diclofenac sodium and Misoprostol products
- 0591-0397 Diclofenac Sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · Actavis Pharma, Inc.
- 65162-436 Diclofenac Sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · Amneal Pharmaceuticals LLC
- 65162-438 Diclofenac Sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · Amneal Pharmaceuticals LLC
- 42291-232 Diclofenac Sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · AvKARE
- 42291-233 Diclofenac Sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · AvKARE
- 68001-231 Diclofenac Sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · BluePoint Laboratories
- 68001-232 Diclofenac Sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · BluePoint Laboratories
- 71335-1183 Diclofenac Sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Delayed Release · Bryant Ranch Prepack
- 80425-0272 Diclofenac Sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Film Coated · Advanced Rx Pharmacy of Tennessee, LLC
- 59762-0028 Diclofenac Sodium 50 mg/1; Misoprostol 200 ug/1 · Tablet, Film Coated · Mylan Pharmaceuticals Inc.
- 59762-0029 Diclofenac Sodium 75 mg/1; Misoprostol 200 ug/1 · Tablet, Film Coated · Mylan Pharmaceuticals Inc.