Diflunisal
- Product NDC
- 0093-9222
- 11-digit product format
- 000939222
- Labeler code
- 0093
- Product ID
- 0093-9222_673f00c6-1759-47a6-a098-fd61baf13d1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diflunisal
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA073673
- Marketing category
- ANDA
- Marketing start
- 2021-06-30
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-9222-01 | Diflunisal | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 21 |
| 0093-9222-05 | Diflunisal | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 21 |
| 0093-9222-06 | Diflunisal | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIFLUNISAL | ACTIVE INGREDIENT | 7C546U4DEN | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| DIFLUNISAL | ACTIVE MOIETY | 7C546U4DEN | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| INDIGOTINDISULFONATE SODIUM | INACTIVE INGREDIENT | D3741U8K7L | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-9222 | DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 21 | Current NDC, Legacy NDC, 3 package rows | 20241219_7a78bb38-14d8-4a90-b883-482d4cebf716.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 |
|---|
| 0093-9222-01 | 00093922201 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01) | 2021-06-30 | 0000-00-00 | No | No | Current |
| 0093-9222-05 | 00093922205 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-9222-05) | 2022-08-25 | 0000-00-00 | No | No | Current |
| 0093-9222-06 | 00093922206 | 60 TABLET, FILM COATED in 1 BOTTLE (0093-9222-06) | 2021-06-30 | 0000-00-00 | No | No | Current |