Diclofenac Sodium
- Product NDC
- 68071-3184
- 11-digit product format
- 680713184
- Labeler code
- 68071
- Product ID
- 68071-3184_1da0c34e-cc8a-9db7-e063-6394a90afe92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- 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 table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855906 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3184-1 | Diclofenac SodiumDelayed Release | 21 in 1 BOTTLE | TABLET, DELAYED RELEASE | 21 | | 4 |
| 68071-3184-2 | Diclofenac SodiumDelayed Release | 20 in 1 BOTTLE | TABLET, DELAYED RELEASE | 20 | | 4 |
| 68071-3184-3 | Diclofenac SodiumDelayed Release | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 4 |
| 68071-3184-5 | Diclofenac SodiumDelayed Release | 45 in 1 BOTTLE | TABLET, DELAYED RELEASE | 45 | | 4 |
| 68071-3184-6 | Diclofenac SodiumDelayed Release | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 4 |
| 68071-3184-9 | Diclofenac SodiumDelayed Release | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3184 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [NUCARE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240720_4b44ac98-225c-1739-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-3184-1 | 68071318401 | 21 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-1) | 2017-03-21 | 0000-00-00 | No | No | Current |
| 68071-3184-2 | 68071318402 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-2) | 2017-03-21 | 0000-00-00 | No | No | Current |
| 68071-3184-3 | 68071318403 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-3) | 2017-03-21 | 0000-00-00 | No | No | Current |
| 68071-3184-5 | 68071318405 | 45 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-5) | 2017-03-21 | 0000-00-00 | No | No | Current |
| 68071-3184-6 | 68071318406 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-6) | 2017-03-21 | 0000-00-00 | No | No | Current |
| 68071-3184-9 | 68071318409 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-9) | 2017-03-21 | 0000-00-00 | No | No | Current |