Amoxicillin and Clavulanate Potassium
- Product NDC
- 71335-2735
- 11-digit product format
- 713352735
- Labeler code
- 71335
- Product ID
- 71335-2735_ec4b0b8c-b9b9-41f1-8b96-b2e5a169b748
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA065064
- Marketing category
- ANDA
- Marketing start
- 2002-03-15
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| AMOXICILLIN | 500 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 617296 |
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 |
|---|
| 71335-2735-1 | 71335273501 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2735-1) | 2025-07-29 | No | No | Current |