Prescription drug · ANDA
Amoxicillin NDC 57237-029
Amoxicillin 875 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-029-01 | 57237002901 | 100 TABLET, FILM COATED in 1 BOTTLE (57237-029-01)Marketed from Nov 9, 2005 | |
| 57237-029-20 | 57237002920 | 20 TABLET, FILM COATED in 1 BOTTLE (57237-029-20)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 — 875 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065256
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 57237-029_679691e2-bbbf-4ed0-a31b-e538b3df75c0SPL ID 679691e2-bbbf-4ed0-a31b-e538b3df75c0SPL set ID bb7733f8-6aad-4273-84a0-ef472630203fRxCUI 308192, 308194UNII 804826J2HUUPC 0357237029015, 0357237028018
- 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
N457237002901followed by a unit qualifier and the quantityPackage 57237-0029-01. 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 tablets 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 tablets 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 tablets are indicated in the treatment of infections due to sus…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065256
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 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0015 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5096 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3872 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1825 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0714 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2191 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-729 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-325 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3886 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4777 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7414 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3675 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2333 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-003 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-028 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0734 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-015 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-014 |
| Amoxicillin | Amoxicillin 875 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0713 |
| Amoxicillin | Amoxicillin 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0709 |
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