Diclofenac Sodium
- Product NDC
- 76420-691
- 11-digit product format
- 764200691
- Labeler code
- 76420
- Product ID
- 76420-691_4850d2cb-f37f-bcae-e063-6294a90aecf7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diclofenac Sodium 1%
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA210986
- Marketing category
- ANDA
- Marketing start
- 2021-03-17
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855633 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-691-01 | Diclofenac Sodium | 1 in 1 CARTON | GEL | 1 | | 2 |
| 76420-691-01 | Diclofenac Sodium | 100 g in 1 TUBE | GEL | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-691 | DICLOFENAC SODIUM (DICLOFENAC SODIUM 1%) GEL [ASCLEMED USA, INC.] | 1 | Current NDC, 2 package rows | 20250131_6952a221-17fd-4592-8edc-ff3699743533.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-691-01 | 76420069101 | 1 TUBE in 1 CARTON (76420-691-01) / 100 g in 1 TUBE | 1 tube | 2023-12-19 | No | No | Historical |