Diclofenac Sodium
- Product NDC
- 51655-280
- 11-digit product format
- 516550280
- Labeler code
- 51655
- Product ID
- 51655-280_48e702c3-71aa-a566-e063-6394a90a7778
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 2022-10-26
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 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
- Brand name suffix
- Delayed Release
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855906 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-280-26 | Diclofenac SodiumDelayed Release | 90 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 90 | | 4 |
| 51655-280-52 | Diclofenac SodiumDelayed Release | 30 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-280 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 2 package rows | 20241218_f2b7ea75-738b-54a8-e053-2995a90a00d5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-280-26 | 51655028026 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-280-26) | 2022-12-06 | No | No | Current |
| 51655-280-52 | 51655028052 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-280-52) | 2022-10-26 | No | No | Current |