DICLOFENAC SODIUM
- Product NDC
- 43386-016
- 11-digit product format
- 433860016
- Labeler code
- 43386
- Product ID
- 43386-016_9d8e578d-3a5b-4d9d-bdac-618067779f81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICLOFENAC SODIUM
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA205878
- Marketing category
- ANDA
- Marketing start
- 2015-12-09
- Substance
- DICLOFENAC SODIUM
- Active strength
- 16.05 mg/mL
- 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 | 16.05 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 857700 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-016-61 | DICLOFENAC SODIUM | 150 mL in 1 BOTTLE | SOLUTION | 150 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-016 | DICLOFENAC SODIUM SOLUTION [LUPIN PHARMACEUTICALS,INC.] | 3 | Current NDC, 1 package rows | 20240322_7559928e-eeb8-47e8-8a55-d59e06bbc737.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 43386-016-61 | 43386001661 | 150 mL in 1 BOTTLE | 150 ml | Historical |