Diclofenac Sodium/Misoprostol
- Product NDC
- 68788-8214
- 11-digit product format
- 687888214
- Labeler code
- 68788
- Product ID
- 68788-8214_869878e8-7391-4206-8b83-3e06fc5a4d2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium/Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA204355
- Marketing category
- ANDA
- Marketing start
- 2022-09-08
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8214 | DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL (DICLOFENAC SODIUM/MISOPROSTOL) TABLET [PREFERRED PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20250316_869878e8-7391-4206-8b83-3e06fc5a4d2a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8214-3 | 68788821403 | 30 TABLET in 1 BOTTLE (68788-8214-3) | 30 tablet | 2022-09-08 | 0000-00-00 | No | No | Current |
| 68788-8214-6 | 68788821406 | 60 TABLET in 1 BOTTLE (68788-8214-6) | 60 tablet | 2022-09-08 | 0000-00-00 | No | No | Current |