Prescription drug · ANDA
Cefprozil NDC 57237-035
Cefprozil 250 mg/5mL · Powder, For suspension · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-035-01 | 5723700350157237003501 | 100 mL in 1 BOTTLE (57237-035-01)Marketed from Jan 30, 2007 | |
| 57237-035-50 | 5723700355057237003550 | 50 mL in 1 BOTTLE (57237-035-50)Marketed from Jan 30, 2007 | |
| 57237-035-75 | 5723700357557237003575 | 75 mL in 1 BOTTLE (57237-035-75)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 — 250 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 57237
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065381
- Marketing start
- Listing expires
- Identifiers
- Product ID 57237-035_2288a04a-b86b-4c3b-8e12-e61531cf5b43SPL ID 2288a04a-b86b-4c3b-8e12-e61531cf5b43SPL set ID d7fac9cc-30e1-4762-a01b-04f1bd3b2a56RxCUI 309080, 309081UNII 4W0459ZA4VUPC 0357237035504
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
N457237003501followed by a unit qualifier and the quantityPackage 57237-0035-01. 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 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 57237-035
- What is NDC 57237-035?
- 57237-035 is the product NDC for Cefprozil, Cefprozil 250 mg/5mL powder, for suspension, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, 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?
- Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 125 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-396 | 16714-0396-03 |
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 125 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 16714-396 |
| 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 125 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-099 |
| Cefprozil | Cefprozil 250 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-100 |