Amoxicillin and Clavulanate Potassium
- Product NDC
- 76420-608
- 11-digit product format
- 764200608
- Labeler code
- 76420
- Product ID
- 76420-608_04ab2de4-f498-1b52-e063-6394a90a5fc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA065101
- Marketing category
- ANDA
- Marketing start
- 2002-10-31
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 500; 125 mg/1; mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 804826J2HU | AMOXICILLIN | 61336-70-7 | AMOXICILLIN |
| Q42OMW3AT8 | CLAVULANATE POTASSIUM | 61177-45-5 | CLAVULANATE POTASSIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-608-20 | 76420060820 | 20 TABLET, FILM COATED in 1 BOTTLE (76420-608-20) | 2023-09-06 | No | No | Historical |