AMOXICILLIN AND CLAVULANATE POTASSIUM
- Product NDC
- 68071-3402
- 11-digit product format
- 680713402
- Labeler code
- 68071
- Product ID
- 68071-3402_0f3c200e-eb4c-5c2d-e063-6294a90a8342
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA204755
- Marketing category
- ANDA
- Marketing start
- 2017-03-01
- 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 |
|---|
| 68071-3402-1 | 68071340201 | 10 TABLET, FILM COATED in 1 BOTTLE (68071-3402-1) | 2023-06-21 | No | No | Historical |
| 68071-3402-3 | 68071340203 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3402-3) | 2023-05-16 | No | No | Historical |
| 68071-3402-4 | 68071340204 | 14 TABLET, FILM COATED in 1 BOTTLE (68071-3402-4) | 2023-05-16 | No | No | Historical |
| 68071-3402-8 | 68071340208 | 28 TABLET, FILM COATED in 1 BOTTLE (68071-3402-8) | 2023-06-21 | No | No | Historical |