Prescription drug · ANDA
Amoxicillin NDC 43063-574
Amoxicillin 250 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-574-04 | 4306305740443063057404 | 4 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-04)Marketed from Jul 12, 2016 | |
| 43063-574-06 | 4306305740643063057406 | 6 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-06)Marketed from Jun 2, 2015 | |
| 43063-574-15 | 4306305741543063057415 | 15 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-15)Marketed from Aug 6, 2015 | |
| 43063-574-21 | 4306305742143063057421 | 21 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-21)Marketed from Oct 6, 2015 | |
| 43063-574-30 | 4306305743043063057430 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-574-30)Marketed from May 12, 2015 |
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 — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- 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 43063-574_32fbc384-f6a4-23ce-e063-6394a90af1e6SPL ID 32fbc384-f6a4-23ce-e063-6394a90af1e6SPL set ID d37f2e3c-01f0-4a81-a46f-1615b82e2499RxCUI 308182UNII 804826J2HUUPC 0343063574157
- 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
N443063057404followed by a unit qualifier and the quantityPackage 43063-0574-04. 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 43063-574
- What is NDC 43063-574?
- 43063-574 is the product NDC for Amoxicillin, Amoxicillin 250 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 5 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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?
- 274 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 250 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-088 | 82868-0088-30 |
| 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 |
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 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4907 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-820 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-017 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0269 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-016 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1512 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7584 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1511 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-4920 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3517 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Redpharm Drug | 67296-2295 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Redpharm Drug | 67296-2292 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1175 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4953 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-508 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | American Health Packaging | 60687-776 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-832 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-056 |
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