Diclofenac Sodium and Misoprostol
- Product NDC
- 68788-9290
- 11-digit product format
- 687889290
- Labeler code
- 68788
- Product ID
- 68788-9290_3c08ad3e-55a9-4fbf-ad30-a9a3c74d38ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium and Misoprostol
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA201089
- Marketing category
- ANDA
- Marketing start
- 2015-03-02
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM; MISOPROSTOL
- Active strength
- 75 mg/1; ug/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-9290-3 | 68788929003 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9290-3) | 2021-04-20 | 0000-00-00 | No | No | Current |
| 68788-9290-6 | 68788929006 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9290-6) | 2015-03-02 | 0000-00-00 | No | No | Current |