Diclofenac Sodium
- Product NDC
- 76420-012
- 11-digit product format
- 764200012
- Labeler code
- 76420
- Product ID
- 76420-012_ead0dde9-f4f4-9f9b-e053-2a95a90ac6e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA206116
- Marketing category
- ANDA
- Marketing start
- 2016-09-02
- 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 |
|---|
| 76420-012-30 | Diclofenac Sodium | 150 mL in 1 BOTTLE | SOLUTION | 150 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-012 | DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20221013_9df599de-6412-a94e-e053-2995a90a1741.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 |
|---|
| 76420-012-30 | 76420001230 | 150 mL in 1 BOTTLE (76420-012-30) | 150 ml | 2020-02-05 | 0000-00-00 | No | No | Current |