Diclofenac Sodium
- Product NDC
- 76420-571
- 11-digit product format
- 764200571
- Labeler code
- 76420
- Product ID
- 76420-571_4ddafa63-9c36-1918-e063-6394a90a7ddc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA090066
- Marketing category
- ANDA
- Marketing start
- 2010-12-31
- Substance
- DICLOFENAC SODIUM
- Active strength
- 25 mg/1
- 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855664, 855906, 855926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-571-01 | Diclofenac Sodium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 2 |
| 76420-571-30 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 2 |
| 76420-571-60 | Diclofenac Sodium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 2 |
| 76420-571-90 | Diclofenac Sodium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-571 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [ASCLEMED USA, INC.] | 1 | Current NDC, 4 package rows | 20240310_2ac9fadc-dc84-4c4a-a12d-dd78ecec93a8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-571-01 | 76420057101 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-571-01) | 2024-03-07 | No | No | Historical |
| 76420-571-30 | 76420057130 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-571-30) | 2024-03-07 | No | No | Historical |
| 76420-571-60 | 76420057160 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-571-60) | 2024-03-07 | No | No | Historical |
| 76420-571-90 | 76420057190 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-571-90) | 2024-03-07 | No | No | Historical |