Prescription drug · ANDA
Amoxicillin NDC 63629-7587
Amoxicillin 500 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-7587-1 | 63629758701 | 20 CAPSULE in 1 BOTTLE (63629-7587-1)Marketed from Jun 16, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064076
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 63629-7587_ea480c9b-00b6-4ba5-8dae-348ad47cba1eSPL ID ea480c9b-00b6-4ba5-8dae-348ad47cba1eSPL set ID 9925773d-8ea1-4193-91e3-52cc1ce5ca67RxCUI 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
N463629758701followed by a unit qualifier and the quantityPackage 63629-7587-01. 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 is 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 is 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 is indicated in the treatment of infections due to susceptible (ONLY β-lactamase…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 064076
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. | 68071-4468 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Coupler LLC | 67046-0127 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Sandoz Inc | 0781-2613 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-0316 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4574 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Sandoz Inc | 0781-2020 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3914 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-072 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2190 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2188 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7585 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7633 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7798 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7801 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-7802 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Proficient Rx LP | 63187-591 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-192 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | QPharma Inc | 42708-153 |