Diclofenac Sodium
- Product NDC
- 80425-0055
- 11-digit product format
- 804250055
- Labeler code
- 80425
- Product ID
- 80425-0055_2a806f57-0229-a1fc-e063-6394a90a1ffa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 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
- DR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0055-1 | Diclofenac SodiumDR | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0055 | DICLOFENAC SODIUM DR (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250101_af8a1392-67e8-8201-e053-2a95a90a0fce.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 |
|---|
| 80425-0055-1 | 80425005501 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0055-1) | 1998-11-13 | 0000-00-00 | No | No | Current |