Prescription drug · ANDA
Amoxicillin NDC 63187-399
Amoxicillin 500 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-399-10 | 63187039910 | 10 CAPSULE in 1 BOTTLE (63187-399-10)Marketed from Mar 1, 2019 | |
| 63187-399-14 | 63187039914 | 14 CAPSULE in 1 BOTTLE (63187-399-14)Marketed from Dec 1, 2018 | |
| 63187-399-20 | 63187039920 | 20 CAPSULE in 1 BOTTLE (63187-399-20)Marketed from Dec 1, 2018 | |
| 63187-399-21 | 63187039921 | 21 CAPSULE in 1 BOTTLE (63187-399-21)Marketed from Dec 1, 2018 | |
| 63187-399-30 | 63187039930 | 30 CAPSULE in 1 BOTTLE (63187-399-30)Marketed from Dec 1, 2018 | |
| 63187-399-40 | 63187039940 | 40 CAPSULE in 1 BOTTLE (63187-399-40)Marketed from Dec 1, 2018 | |
| 63187-399-60 | 63187039960 | 60 CAPSULE in 1 BOTTLE (63187-399-60)Marketed from Apr 1, 2019 | |
| 63187-399-90 | 63187039990 | 90 CAPSULE in 1 BOTTLE (63187-399-90)Marketed from Apr 1, 2019 |
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
- Proficient Rx LPNDC labeler code 63187
- 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 63187-399_e9e9012e-430a-482e-8cc1-a10c37aec36cSPL ID e9e9012e-430a-482e-8cc1-a10c37aec36cSPL set ID ef03286b-4ba7-4952-9ab1-90cacf300504RxCUI 308191UNII 804826J2HUUPC 0363187399207
- 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
N463187039910followed by a unit qualifier and the quantityPackage 63187-0399-10. 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, USP and other antibacterial drugs, amoxicillin capsules, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin capsules, USP are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the con…
Excerpt only. Read the full label for complete information.
About NDC 63187-399
- What is NDC 63187-399?
- 63187-399 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 8 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?
- Proficient Rx LP, NDC labeler code 63187. 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?
- 272 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 500 mg/1 | CapsuleOral | QPharma Inc | 42708-076 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5019 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | American Health Packaging | 60687-787 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1514 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1511 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3574 |
| 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 | Sportpharm LLC | 85766-185 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | HAWAII REPACK, INC. | 85534-0040 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4455 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3832 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0895 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1796 |
| 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 | 50090-1811 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-1797 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals, Inc. | 68071-3119 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4548 |
Showing 20 of 39.