Diclofenac Sodium
- Product NDC
- 76420-261
- 11-digit product format
- 764200261
- Labeler code
- 76420
- Product ID
- 76420-261_e709b84d-fa7d-3f23-e053-2995a90aacd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA206493
- Marketing category
- ANDA
- Marketing start
- 2016-05-19
- 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 |
|---|
| 76420-261-01 | Diclofenac Sodium | 1 in 1 CARTON | GEL | 1 | | 1 |
| 76420-261-01 | 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 |
|---|
| 76420-261 | DICLOFENAC SODIUM GEL [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220826_b162d65d-b105-4a68-90bb-316b9686267b.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 |
|---|
| 76420-261-01 | 76420026101 | 1 TUBE in 1 CARTON (76420-261-01) / 100 g in 1 TUBE | 1 tube | 2022-08-24 | 0000-00-00 | No | No | Current |