Amoxicillin and Clavulanate Potassium
- Product NDC
- 53002-3716
- 11-digit product format
- 530023716
- Labeler code
- 53002
- Product ID
- 53002-3716_c65de933-1491-4d39-931a-35aa827c6336
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA201091
- Marketing category
- ANDA
- Marketing start
- 2011-12-20
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 600 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-3716-1 | 53002371601 | 200 mL in 1 BOTTLE, PLASTIC (53002-3716-1) | 200 ml | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-3716-2 | 53002371602 | 75 mL in 1 BOTTLE, PLASTIC (53002-3716-2) | 75 ml | 2021-01-01 | 0000-00-00 | No | No | Current |