Diclofenac Sodium
- Product NDC
- 76420-134
- 11-digit product format
- 764200134
- Labeler code
- 76420
- Product ID
- 76420-134_b965985a-9568-58f3-e053-2995a90a008c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION/ DROPS
- Route
- TRANSDERMAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA204132
- Marketing category
- ANDA
- Marketing start
- 2015-08-20
- 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 |
|---|
| 76420-134-05 | Diclofenac Sodium | 150 mL in 1 BOTTLE | SOLUTION/ DROPS | 150 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-134 | DICLOFENAC SODIUM SOLUTION/ DROPS [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20210122_f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8.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 |
|---|
| 76420-134-05 | 76420013405 | 150 mL in 1 BOTTLE (76420-134-05) | 150 ml | 2021-01-21 | 0000-00-00 | No | No | Current |