Amoxicillin and Clavulanate Potassium
- Product NDC
- 68788-8836
- 11-digit product format
- 687888836
- Labeler code
- 68788
- Product ID
- 68788-8836_a0822381-ba9a-4f80-bc4f-608301d07fd8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA091568
- Marketing category
- ANDA
- Marketing start
- 2025-02-27
- 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
openFDA Listing Details
- Product ID
- 68788-8836_a0822381-ba9a-4f80-bc4f-608301d07fd8
- SPL ID
- a0822381-ba9a-4f80-bc4f-608301d07fd8
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Generic name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2025-02-27
- Marketing category
- ANDA
- Application number
- ANDA091568
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC]; Penicillins [CS]; beta Lactamase Inhibitor [EPC]; beta Lactamase Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| AMOXICILLIN | 875 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 562508 |
| Spl Set Id | a0822381-ba9a-4f80-bc4f-608301d07fd8 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68788-8836-2 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8836-2) | 2025-02-27 | No |
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 |
|---|
| 68788-8836-2 | 68788883602 | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8836-2) | 2025-02-27 | No | No | Historical |