Prescription drug · ANDA
Cefprozil NDC 16714-396
Cefprozil 125 mg/5mL · Powder, For suspension · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-396-03 | 1671403960316714039603 | 100 mL in 1 BOTTLE (16714-396-03)Marketed from Jan 30, 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 — 125 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- NorthStar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065381
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-396_a623c2b2-f643-4ab4-aef5-60686abf7b88SPL ID a623c2b2-f643-4ab4-aef5-60686abf7b88SPL set ID 8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4RxCUI 309080, 309081UNII 4W0459ZA4VUPC 0316714397016
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
N416714039603followed by a unit qualifier and the quantityPackage 16714-0396-03. 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 for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designat…
Excerpt only. Read the full label for complete information.
About NDC 16714-396
- What is NDC 16714-396?
- 16714-396 is the product NDC for Cefprozil, Cefprozil 125 mg/5mL powder, for suspension, 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 250 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-398 | 16714-0398-01 |
| 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 250 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-397 | 16714-0397-0116714-0397-0216714-0397-03 |
Other NDCs under ANDA 065381
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 250 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-397 |
| Cefprozil | Cefprozil 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-3226 |
| Cefprozil | Cefprozil 125 mg/5mL | Powder, For suspensionOral | Rising Pharma Holdings, Inc. | 57237-034 |
| Cefprozil | Cefprozil 250 mg/5mL | Powder, For suspensionOral | Rising Pharma Holdings, Inc. | 57237-035 |
| Cefprozil | Cefprozil 125 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-099 |
| Cefprozil | Cefprozil 250 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-100 |