Diclofenac Sodium
- Product NDC
- 63629-2077
- 11-digit product format
- 636292077
- Labeler code
- 63629
- Product ID
- 63629-2077_3f8c444c-5789-4b85-a7c6-a215dbcc42ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Brand name suffix
- Delayed Release
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 50 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855906 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| QTG126297Q | DICLOFENAC SODIUM | 15307-79-6 | DICLOFENAC SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-2077-1 | 63629207701 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-2077-1) | 2021-02-04 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Diclofenac Sodium | Bryant Ranch Prepack | 2024-08-08 | HUMAN PRESCRIPTION DRUG LABEL | 103 |