Prescription drug · ANDA
Amoxicillin NDC 76420-545
Amoxicillin 500 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-545-50 | 76420054550 | 50 CAPSULE in 1 BOTTLE (76420-545-50)Marketed from Mar 18, 2023 |
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
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 061926
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 76420-545_f7278cd0-99b5-9e8e-e053-6294a90a66e7SPL ID f7278cd0-99b5-9e8e-e053-6294a90a66e7SPL set ID be1d1a44-7ef3-445d-9970-494921de4c9dRxCUI 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
N476420054550followed by a unit qualifier and the quantityPackage 76420-0545-50. 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 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 indicated in the treatment of infections due to suscept…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 061926
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 | Teva Pharmaceuticals USA, Inc. | 0093-3107 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-3109 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-082 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-083 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4741 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | Redpharm Drug | 67296-0002 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | QPharma, Inc | 42708-010 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4944 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | Chartwell Governmental & Specialty RX, LLC | 68999-083 |