Diclofenac Potassium
- Product NDC
- 60290-057
- 11-digit product format
- 602900057
- Labeler code
- 60290
- Product ID
- 60290-057_4ff2886d-ca64-3bf4-e063-6394a90ac3ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Potassium Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Umedica Laboratories USA Inc.
- Application
- ANDA215750
- Marketing category
- ANDA
- Marketing start
- 2022-05-12
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Potassium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC POTASSIUM | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L4D5UA6CB4 |
| Rxcui | 855942, 857702 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60290-057-01 | Diclofenac Potassium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 60290-057-02 | Diclofenac Potassium | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 11 |
| 60290-057-03 | Diclofenac Potassium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60290-057 | DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM TABLETS) TABLET, FILM COATED [UMEDICA LABORATORIES PRIVATE LIMITED] | 5 | Current NDC, Legacy NDC, 3 package rows | 20241225_1fa07fbe-3708-4200-b3ff-a920434896b6.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 |
|---|
| 60290-057-01 | 60290005701 | 100 TABLET, FILM COATED in 1 BOTTLE (60290-057-01) | 2022-05-12 | 0000-00-00 | No | No | Current |
| 60290-057-02 | 60290005702 | 1000 TABLET, FILM COATED in 1 BOTTLE (60290-057-02) | 2022-05-12 | 0000-00-00 | No | No | Current |
| 60290-057-03 | 60290005703 | 500 TABLET, FILM COATED in 1 BOTTLE (60290-057-03) | 2022-05-12 | | No | No | Historical |