Amoxicillin and Clavulanate Potassium
- Product NDC
- 82804-017
- 11-digit product format
- 828040017
- Labeler code
- 82804
- Product ID
- 82804-017_e05caabb-b95c-4e54-890e-bbc371a20fc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA201091
- Marketing category
- ANDA
- Marketing start
- 2011-12-20
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 600; 42.9 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 |
|---|
| 82804-017-12 | 82804001712 | 125 mL in 1 BOTTLE (82804-017-12) | 125 ml | 2023-10-05 | No | No | Historical |