Diflunisal
- Product NDC
- 68382-530
- 11-digit product format
- 683820530
- Labeler code
- 68382
- Product ID
- 68382-530_15c3b31f-e781-4406-a5b4-56c653ecff80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diflunisal
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA203547
- Marketing category
- ANDA
- Marketing start
- 2017-09-14
- Substance
- DIFLUNISAL
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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
- Diflunisal
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIFLUNISAL | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7C546U4DEN |
| Rxcui | 197603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-530 | DIFLUNISAL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | Current NDC, Legacy NDC, 8 package rows | 20240806_5baf9f35-6b5e-4666-a14a-ac0f9d4e9f76.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 |
|---|
| 68382-530-01 | 68382053001 | 100 TABLET in 1 BOTTLE (68382-530-01) | 100 tablet | 2017-09-14 | 0000-00-00 | No | No | Current |
| 68382-530-05 | 68382053005 | 500 TABLET in 1 BOTTLE (68382-530-05) | 500 tablet | 2017-09-14 | 0000-00-00 | No | No | Current |
| 68382-530-06 | 68382053006 | 30 TABLET in 1 BOTTLE (68382-530-06) | 30 tablet | 2017-09-14 | 0000-00-00 | No | No | Current |
| 68382-530-10 | 68382053010 | 1000 TABLET in 1 BOTTLE (68382-530-10) | 1000 tablet | 2017-09-14 | 0000-00-00 | No | No | Current |
| 68382-530-14 | 68382053014 | 60 TABLET in 1 BOTTLE (68382-530-14) | 60 tablet | 2017-09-14 | 0000-00-00 | No | No | Current |
| 68382-530-16 | 68382053016 | 90 TABLET in 1 BOTTLE (68382-530-16) | 90 tablet | 2017-09-14 | 0000-00-00 | No | No | Current |
| 68382-530-30 | 68382053030 | 10 BLISTER PACK in 1 CARTON (68382-530-30) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2017-09-14 | 0000-00-00 | No | No | Current |