Diclofenac Sodium
- Product NDC
- 80425-0569
- 11-digit product format
- 804250569
- Labeler code
- 80425
- Product ID
- 80425-0569_47a7a66e-0806-6ab3-e063-6394a90a9406
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 2025-12-31
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Brand name suffix
- Delayed Release
- Listing expiration
- 2027-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0569-1 | Diclofenac SodiumDelayed Release | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 1 |
| 80425-0569-2 | Diclofenac SodiumDelayed Release | 90 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0569-1 | 80425056901 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80425-0569-1) | 2026-01-05 | No | No | Historical |
| 80425-0569-2 | 80425056902 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80425-0569-2) | 2026-01-05 | No | No | Historical |