AMOXICILLIN AND CLAVULANATE POTASSIUM
- Product NDC
- 70518-3967
- 11-digit product format
- 705183967
- Labeler code
- 70518
- Product ID
- 70518-3967_4a2d17f3-252e-1e4b-e063-6394a90aecdc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204755
- Marketing category
- ANDA
- Marketing start
- 2023-12-19
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3967-0 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | | 7 |
| 70518-3967-1 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-3967-0 | 70518396700 | 28 in 1 BOTTLE, PLASTIC | | | | Historical |
| 70518-3967-1 | 70518396701 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3967-1) | 2026-02-06 | No | No | Historical |