Cefprozil
- Product NDC
- 16714-399
- 11-digit product format
- 167140399
- Labeler code
- 16714
- Product ID
- 16714-399_1fef82c2-7104-4649-bf85-6d7bef37262e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefprozil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA065340
- Marketing category
- ANDA
- Marketing start
- 2007-05-24
- 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 |
|---|
| 16714-399-01 | Cefprozil | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEFPROZIL | ACTIVE INGREDIENT | 4W0459ZA4V | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| CEFPROZIL ANHYDROUS | ACTIVE MOIETY | 1M698F4H4E | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-399 | CEFPROZIL TABLET, FILM COATED [NORTHSTAR RX LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240507_6133611e-19c1-4df2-8c23-8573aaf63020.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 |
|---|
| 16714-399-01 | 16714039901 | 50 TABLET, FILM COATED in 1 BOTTLE (16714-399-01) | 2007-05-24 | 0000-00-00 | No | No | Current |