Diclofenac sodium
- Product NDC
- 76420-598
- 11-digit product format
- 764200598
- Labeler code
- 76420
- Product ID
- 76420-598_045ce619-2c60-e219-e063-6294a90a8cd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA216275
- Marketing category
- ANDA
- Marketing start
- 2022-09-26
- Substance
- DICLOFENAC SODIUM
- Active strength
- 100 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855657 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-598-07 | Diclofenac sodium | 7 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 7 | | 1 |
| 76420-598-10 | Diclofenac sodium | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
| 76420-598-14 | Diclofenac sodium | 14 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 14 | | 1 |
| 76420-598-20 | Diclofenac sodium | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 1 |
| 76420-598-30 | Diclofenac sodium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 76420-598-60 | Diclofenac sodium | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 76420-598-90 | Diclofenac sodium | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-598 | DICLOFENAC SODIUM TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Current NDC, 7 package rows | 20230906_6a9c3cea-7b46-427d-99af-90c1f290b190.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-598-07 | 76420059807 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-07) | 2023-09-02 | No | No | Historical |
| 76420-598-10 | 76420059810 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-10) | 2023-09-02 | No | No | Historical |
| 76420-598-14 | 76420059814 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-14) | 2023-09-02 | No | No | Historical |
| 76420-598-20 | 76420059820 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-20) | 2023-09-02 | No | No | Historical |
| 76420-598-30 | 76420059830 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-30) | 2023-09-02 | No | No | Historical |
| 76420-598-60 | 76420059860 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-60) | 2023-09-02 | No | No | Historical |
| 76420-598-90 | 76420059890 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-90) | 2023-09-02 | No | No | Historical |