Prescription drug · ANDA
Amoxicillin NDC 57237-031
Amoxicillin 500 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-031-01 | 57237003101 | 100 CAPSULE in 1 BOTTLE (57237-031-01)Marketed from Nov 9, 2005 | |
| 57237-031-05 | 57237003105 | 500 CAPSULE in 1 BOTTLE (57237-031-05)Marketed from Nov 9, 2005 |
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)
- Amoxicillin
- Generic name (nonproprietary)
- amoxicillin
- Active ingredients
- Amoxicillin — 500 mg/1
- Dosage form
- Capsule
- 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 065271
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 57237-031_4e6f21c7-0e2a-4361-9549-ab42efd08d5bSPL ID 4e6f21c7-0e2a-4361-9549-ab42efd08d5bSPL set ID bbe590a0-4196-4885-b679-cc1833af567fRxCUI 308182, 308191UNII 804826J2HU
- Pharmacologic class
- Penicillin-class Antibacterial
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
N457237003101followed by a unit qualifier and the quantityPackage 57237-0031-01. 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)
Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β- lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract: Amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Infections of the Skin and Skin Structure: Amoxicillin capsules are indicated in the treatment of infections due to…
Excerpt only. Read the full label for complete information.
About NDC 57237-031
- What is NDC 57237-031?
- 57237-031 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amoxicillin.
- What is the active ingredient?
- Amoxicillin.
- 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 Amoxicillin?
- 268 other product NDCs are listed under this name. See all Amoxicillin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amoxicillin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0734 | 67046-0734-03 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4152 | 68788-4152-02 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-0316 | 67046-0316-03 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Coupler LLC | 67046-0127 | 67046-0127-03 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0015 | 67046-0015-03 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1175 | 67046-1175-03 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-4062 | 68788-4062-02 |
| Amoxicillin | Amoxicillin 400 mg/5mL | For suspensionOral | REMEDYREPACK INC. | 70518-4529 | 70518-4529-00 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | REMEDYREPACK INC. | 70518-4522 | 70518-4522-00 |
| Amoxicillin | Amoxicillin 400 mg/5mL | Powder, For suspensionOral | REMEDYREPACK INC. | 70518-4521 | 70518-4521-00 |
Other NDCs under ANDA 065271
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 |
|---|---|---|---|---|
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-298 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-299 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | QPharma Inc | 42708-076 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-574 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-820 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-915 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1511 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1512 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1513 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1514 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1794 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1795 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1796 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1797 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1810 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1811 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1812 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1813 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1826 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Northwind Pharmaceuticals, LLC | 51655-156 |
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