Cefprozil
- Product NDC
- 16714-397
- 11-digit product format
- 167140397
- Labeler code
- 16714
- Product ID
- 16714-397_f8a7ccea-370c-4afe-92f2-2f4bcc925669
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefprozil
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA065381
- Marketing category
- ANDA
- Marketing start
- 2007-01-30
- Substance
- CEFPROZIL
- Active strength
- 250 mg/5mL
- 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 | 250 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4W0459ZA4V |
| Rxcui | 309080, 309081 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-397-01 | Cefprozil | 50 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 50 | | 8 |
| 16714-397-02 | Cefprozil | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 8 |
| 16714-397-03 | Cefprozil | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEFPROZIL | ACTIVE INGREDIENT | 4W0459ZA4V | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| CEFPROZIL ANHYDROUS | ACTIVE MOIETY | 1M698F4H4E | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-397 | CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240521_8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4.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 |
|---|
| 16714-397-01 | 16714039701 | 50 mL in 1 BOTTLE (16714-397-01) | 50 ml | 2007-01-30 | 0000-00-00 | No | No | Current |
| 16714-397-02 | 16714039702 | 75 mL in 1 BOTTLE (16714-397-02) | 75 ml | 2007-01-30 | 0000-00-00 | No | No | Current |
| 16714-397-03 | 16714039703 | 100 mL in 1 BOTTLE (16714-397-03) | 100 ml | 2007-01-30 | 0000-00-00 | No | No | Current |