Amoxicillin and Clavulanate Potassium
- Product NDC
- 76420-864
- 11-digit product format
- 764200864
- Labeler code
- 76420
- Product ID
- 76420-864_25322eee-f92a-5838-e063-6394a90aa376
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA201090
- Marketing category
- ANDA
- Marketing start
- 2011-12-20
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 400; 57 mg/5mL; mg/5mL
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-864-01 | 76420086401 | 100 mL in 1 BOTTLE (76420-864-01) | 100 ml | 2024-10-24 | No | No | Historical |
| 76420-864-50 | 76420086450 | 50 mL in 1 BOTTLE (76420-864-50) | 50 ml | 2024-10-24 | No | No | Historical |
| 76420-864-75 | 76420086475 | 75 mL in 1 BOTTLE (76420-864-75) | 75 ml | 2024-10-24 | No | No | Historical |