Prescription drug · ANDA
Amoxicillin NDC 81964-350
Amoxicillin 500 mg/1 · Capsule · Oral · USAntibiotics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81964-350-10 | 8196403501081964035010 | 100 CAPSULE in 1 BOTTLE (81964-350-10)Marketed from May 15, 2025 | |
| 81964-350-60 | 8196403506081964035060 | 60 CAPSULE in 1 BOTTLE (81964-350-60)Marketed from May 15, 2025 | |
| 81964-350-98 | 8196403509881964035098 | 8 CAPSULE in 1 PAIL (81964-350-98)Marketed from May 15, 2025 |
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
- USAntibiotics, LLCNDC labeler code 81964
- 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 81964-350_5253eb61-6d82-8057-e063-6294a90a5c84SPL ID 5253eb61-6d82-8057-e063-6294a90a5c84SPL set ID 110ba6b1-f175-48a1-8e30-616c02212538RxCUI 308182, 308191UNII 804826J2HUUPC 0381964350982, 0381964350104, 0381964225013, 0381964225051, 0381964350609
- 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
N481964035010followed by a unit qualifier and the quantityPackage 81964-0350-10. 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)
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 or prevent 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 …
Excerpt only. Read the full label for complete information.
About NDC 81964-350
- What is NDC 81964-350?
- 81964-350 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by USAntibiotics, LLC. It has 3 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?
- USAntibiotics, LLC, NDC labeler code 81964. 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 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 | Redpharm Drug | 67296-1914 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4371 |
| Amoxicillin | Amoxicillin 500 mg/1 | CapsuleOral | USAntibiotics, LLC | 81964-205 |
| Amoxicillin | Amoxicillin 250 mg/1 | CapsuleOral | USAntibiotics, LLC | 81964-225 |