Amoxicillin and Clavulanate Potassium
- Product NDC
- 68071-5057
- 11-digit product format
- 680715057
- Labeler code
- 68071
- Product ID
- 68071-5057_1b43176e-f84c-c448-e063-6394a90a6b0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA203824
- Marketing category
- ANDA
- Marketing start
- 2016-08-23
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2026-12-31
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 |
|---|
| 68071-5057-3 | Amoxicillin and Clavulanate Potassium | 3 in 1 BOTTLE | TABLET | 3 | | 5 |
| 68071-5057-4 | Amoxicillin and Clavulanate Potassium | 4 in 1 BOTTLE | TABLET | 4 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5057 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240620_9263495c-310a-c20e-e053-2995a90a2e87.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-5057-3 | 68071505703 | 3 TABLET in 1 BOTTLE (68071-5057-3) | 3 tablet | 2019-09-12 | 0000-00-00 | No | No | Current |
| 68071-5057-4 | 68071505704 | 4 TABLET in 1 BOTTLE (68071-5057-4) | 4 tablet | 2019-09-12 | 0000-00-00 | No | No | Current |