Diclofenac sodium
- Product NDC
- 76420-275
- 11-digit product format
- 764200275
- Labeler code
- 76420
- Product ID
- 76420-275_e83802ce-a8c7-e6a6-e053-2995a90a5256
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA206298
- Marketing category
- ANDA
- Marketing start
- 2016-04-28
- Substance
- DICLOFENAC SODIUM
- Active strength
- 30 mg/g
- 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 | 30 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855642 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-275-01 | Diclofenac sodium | 100 g in 1 TUBE | GEL | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-275 | DICLOFENAC SODIUM GEL [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20220911_d4b81a74-6926-4715-bf90-aec026cff2b4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-275-01 | 76420027501 | 100 g in 1 TUBE (76420-275-01) | 100 g | 2022-09-09 | 0000-00-00 | No | No | Current |