Diclofenac Sodium
- Product NDC
- 50090-0542
- 11-digit product format
- 500900542
- Labeler code
- 50090
- Product ID
- 50090-0542_a9e9de92-75b1-4d34-b78c-99693142c155
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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, 855926 |
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 |
|---|
| 50090-0542-0 | Diclofenac Sodium Delayed Release | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 43 |
| 50090-0542-2 | Diclofenac Sodium Delayed Release | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 43 |
| 50090-0542-5 | Diclofenac Sodium Delayed Release | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 43 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-0542 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS] | 43 | Current NDC, Legacy NDC, 3 package rows | 20241025_70156824-e5dd-42b1-9b4f-a49acb28d316.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 |
|---|
| 50090-0542-0 | 50090054200 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0542-0) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0542-2 | 50090054202 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0542-2) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0542-5 | 50090054205 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0542-5) | 2015-07-20 | 0000-00-00 | No | No | Current |