Diclofenac Sodium
- Product NDC
- 68788-8193
- 11-digit product format
- 687888193
- Labeler code
- 68788
- Product ID
- 68788-8193_403085a5-446c-4796-aaf1-64be07a98c9a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077863
- Marketing category
- ANDA
- Marketing start
- 2022-05-16
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 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 | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8193-1 | Diclofenac Sodium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 5 |
| 68788-8193-3 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 5 |
| 68788-8193-6 | Diclofenac Sodium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 5 |
| 68788-8193-8 | Diclofenac Sodium | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 5 |
| 68788-8193-9 | Diclofenac Sodium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8193 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 5 package rows | 20250317_ed1b5ec7-2812-4a81-90d1-953baa0b0ec8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8193-1 | 68788819301 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-1) | 2022-05-16 | 0000-00-00 | No | No | Current |
| 68788-8193-3 | 68788819303 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-3) | 2022-05-16 | 0000-00-00 | No | No | Current |
| 68788-8193-6 | 68788819306 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-6) | 2022-05-16 | 0000-00-00 | No | No | Current |
| 68788-8193-8 | 68788819308 | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-8) | 2022-05-16 | 0000-00-00 | No | No | Current |
| 68788-8193-9 | 68788819309 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-9) | 2022-05-16 | 0000-00-00 | No | No | Current |