DICLOFENAC POTASSIUM
- Product NDC
- 71337-046
- 11-digit product format
- 713370046
- Labeler code
- 71337
- Product ID
- 71337-046_2a1e049f-58f9-40e8-b7a6-bcd19ef51f75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac potassium, film coated
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Havix Group Inc d-b-a Aavis Pharmaceuticals
- Application
- ANDA215787
- Marketing category
- ANDA
- Marketing start
- 2023-06-25
- Substance
- DICLOFENAC POTASSIUM
- 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 POTASSIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC POTASSIUM | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L4D5UA6CB4 |
| Rxcui | 855942 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71337-046-01 | DICLOFENAC POTASSIUM | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 71337-046-05 | DICLOFENAC POTASSIUM | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71337-046 | DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM, FILM COATED) TABLET [HAVIX GROUP INC D-B-A AAVIS PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20230629_30ab7b30-cc90-4b84-8caf-21058f1d37fa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71337-046-01 | 71337004601 | 100 TABLET in 1 BOTTLE (71337-046-01) | 100 tablet | 2023-06-26 | No | No | Current |
| 71337-046-05 | 71337004605 | 500 TABLET in 1 BOTTLE (71337-046-05) | 500 tablet | 2023-06-26 | No | No | Current |