Amoxicillin and Clavulanate Potassium
- Product NDC
- 85766-019
- 11-digit product format
- 857660019
- Labeler code
- 85766
- Product ID
- 85766-019_4a022ff2-b0e8-9063-e063-6294a90a8fbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA091568
- Marketing category
- ANDA
- Marketing start
- 2012-01-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 875 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 562508, 617296 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-019-01 | Amoxicillin and Clavulanate Potassium | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 85766-019-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-019-01 | 85766001901 | 100 TABLET, FILM COATED in 1 BOTTLE (85766-019-01) | 2026-02-03 | No | No | Current |
| 85766-019-20 | 85766001920 | 20 TABLET, FILM COATED in 1 BOTTLE (85766-019-20) | 2025-08-13 | No | No | Current |