Cefprozil
- Product NDC
- 0093-1078
- 11-digit product format
- 000931078
- Labeler code
- 0093
- Product ID
- 0093-1078_c226712f-00c2-407f-8b40-5ed1be54dfb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefprozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA065208
- Marketing category
- ANDA
- Marketing start
- 2005-12-23
- Substance
- CEFPROZIL
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cefprozil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CEFPROZIL | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4W0459ZA4V |
| Rxcui | 197452, 197453 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-1078-53 | Cefprozil | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEFPROZIL | ACTIVE INGREDIENT | 4W0459ZA4V | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CEFPROZIL ANHYDROUS | ACTIVE MOIETY | 1M698F4H4E | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEFPROZIL 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 |
|---|
| 0093-1078 | CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20220315_3391de8b-7bc9-4624-a5c4-836135b39d99.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 |
|---|
| 0093-1078-53 | 00093107853 | 50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53) | 2005-12-23 | 0000-00-00 | No | No | Current |