Diclofenac Sodium
- Product NDC
- 76420-091
- 11-digit product format
- 764200091
- Labeler code
- 76420
- Product ID
- 76420-091_b269742f-932d-73f2-e053-2a95a90a3761
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium Topical Gel, 1%,
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA210986
- Marketing category
- ANDA
- Marketing start
- 2020-01-30
- Substance
- DICLOFENAC SODIUM
- Active strength
- 10 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 |
|---|
| DICLOFENAC SODIUM | 10 mg/g |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855633 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| QTG126297Q | DICLOFENAC SODIUM | 15307-79-6 | DICLOFENAC SODIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-091-01 | 76420009101 | 100 g in 1 TUBE (76420-091-01) | 100 g | 2020-10-24 | 0000-00-00 | No | No | Current |