diflunisal
- Product NDC
- 14539-673
- 11-digit product format
- 145390673
- Labeler code
- 14539
- Product ID
- 14539-673_0f1ed721-7842-4b8e-9f10-cf697531e750
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diflunisal
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Application
- ANDA202845
- Marketing category
- ANDA
- Marketing start
- 2012-03-08
- 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 | 197602, 197603, 249400 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 14539-673-01 | diflunisal | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 14539-673-05 | diflunisal | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 13 |
| 14539-673-06 | diflunisal | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14539-673 | DIFLUNISAL TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] | 13 | Current NDC, Legacy NDC, 3 package rows | 20240829_666f89b4-fd81-420a-a390-eb1cd4014f61.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 |
|---|
| 14539-673-01 | 14539067301 | 100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01) | 2019-01-09 | 0000-00-00 | No | No | Current |
| 14539-673-05 | 14539067305 | 500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05) | 2019-01-09 | 0000-00-00 | No | No | Current |
| 14539-673-06 | 14539067306 | 60 TABLET, FILM COATED in 1 BOTTLE (14539-673-06) | 2019-01-09 | 0000-00-00 | No | No | Current |