Diclofenac Potassium
- Product NDC
- 75834-337
- 11-digit product format
- 758340337
- Labeler code
- 75834
- Product ID
- 75834-337_4580c689-1082-1dc8-e063-6294a90afff4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Potassium Tablets
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NIVAGEN PHARMACEUTICALS, INC.
- Application
- ANDA215750
- Marketing category
- ANDA
- Marketing start
- 2025-10-10
- Substance
- DICLOFENAC POTASSIUM
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L4D5UA6CB4 |
| Rxcui | 857702 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75834-337-30 | Diclofenac Potassium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 75834-337-60 | Diclofenac Potassium | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 75834-337-30 | 75834033730 | 30 TABLET, FILM COATED in 1 BOTTLE (75834-337-30) | 2025-10-10 | No | No | Current |
| 75834-337-60 | 75834033760 | 60 TABLET, FILM COATED in 1 BOTTLE (75834-337-60) | 2025-10-10 | No | No | Current |