Amoxicillin and Clavulanate Potassium
- Product NDC
- 68071-3866
- 11-digit product format
- 680713866
- Labeler code
- 68071
- Product ID
- 68071-3866_377abca8-7077-9ad0-e063-6294a90aa5dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA065063
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875; 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 |
|---|
| 68071-3866-3 | 68071386603 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3866-3) | 2025-06-13 | No | No | Historical |