Prescription drug · ANDA
Amoxicillin NDC 67296-1914
Amoxicillin 500 mg/1 · Capsule · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-1914-3 | 67296191403 | 30 CAPSULE in 1 BOTTLE (67296-1914-3)Marketed from Sep 15, 2022 | |
| 67296-1914-4 | 67296191404 | 40 CAPSULE in 1 BOTTLE (67296-1914-4)Marketed from Sep 15, 2022 | |
| 67296-1914-6 | 67296191406 | 60 CAPSULE in 1 BOTTLE (67296-1914-6)Marketed from Sep 15, 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
- Redpharm Drug
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062216
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)
- Identifiers
- Product ID 67296-1914_3251e4b2-f17c-f99f-e063-6394a90a6af9SPL ID 3251e4b2-f17c-f99f-e063-6394a90a6af9SPL set ID 0a100e76-513c-98d3-e063-6294a90adf47RxCUI 308191UNII 804826J2HUUPC 0381964225013, 0381964225051
- 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
N467296191403followed by a unit qualifier and the quantityPackage 67296-1914-03. 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)
Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 to 1.4 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Infections of the Ear, Nose, and Throat Amoxicillin is indicated in the treatment of…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062216
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 | REMEDYREPACK INC. | 70518-4371 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | USAntibiotics, LLC | 81964-205 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | USAntibiotics, LLC | 81964-350 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | USAntibiotics, LLC | 81964-225 |