Prescription drug · ANDA
Cefprozil NDC 16714-398
Cefprozil 250 mg/1 · Tablet, Film coated · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-398-01 | 1671403980116714039801 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-398-01)Marketed from May 24, 2007 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Cefprozil
- Generic name (nonproprietary)
- cefprozil
- Active ingredients
- Cefprozil — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NorthStar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065340
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-398_1fef82c2-7104-4649-bf85-6d7bef37262eSPL ID 1fef82c2-7104-4649-bf85-6d7bef37262eSPL set ID 6133611e-19c1-4df2-8c23-8573aaf63020RxCUI 197452, 197453UNII 4W0459ZA4V
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N416714039801followed by a unit qualifier and the quantityPackage 16714-0398-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorg…
Excerpt only. Read the full label for complete information.
About NDC 16714-398
- What is NDC 16714-398?
- 16714-398 is the product NDC for Cefprozil, Cefprozil 250 mg/1 tablet, film coated, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefprozil.
- What is the active ingredient?
- Cefprozil.
- Who is the labeler?
- NorthStar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefprozil?
- 21 other product NDCs are listed under this name. See all Cefprozil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefprozil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefprozil | Cefprozil 250 mg/5mL | Powder, For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-273 | 68180-0273-0168180-0273-0268180-0273-03 |
| Cefprozil | Cefprozil 500 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-243 | 67877-0243-50 |
| Cefprozil | Cefprozil 250 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-244 | 67877-0244-01 |
| Cefprozil | Cefprozil 500 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-399 | 16714-0399-01 |
| Cefprozil | Cefprozil 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1710 | 50090-1710-00 |
| Cefprozil | Cefprozil 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-036 | 57237-0036-01 |
| Cefprozil | Cefprozil 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-037 | 57237-0037-0157237-0037-50 |
| Cefprozil | Cefprozil 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-068 | 65862-0068-0165862-0068-0565862-0068-30+1 more |
| Cefprozil | Cefprozil 125 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-396 | 16714-0396-03 |
| Cefprozil | Cefprozil 250 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-397 | 16714-0397-0116714-0397-0216714-0397-03 |
Other NDCs under ANDA 065340
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cefprozil | Cefprozil 500 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-399 |
| Cefprozil | Cefprozil 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1710 |
| Cefprozil | Cefprozil 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-036 |
| Cefprozil | Cefprozil 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-037 |
| Cefprozil | Cefprozil 250 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-068 |