AMOXICILLIN AND CLAVULANATE POTASSIUM
- Product NDC
- 68071-4224
- 11-digit product format
- 680714224
- Labeler code
- 68071
- Product ID
- 68071-4224_440bc10d-a2fd-a450-e063-6394a90aabfe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA204755
- Marketing category
- ANDA
- Marketing start
- 2017-03-01
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4224-2 | 2024-06-06 | C162847 | 48780-1 | ba0f9c33-1aea-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate po |
| 68071-4224-2 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1aea-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate po |
| 68071-4224-2 | 2021-02-15 | C162847 | 48780-1 | ba0f9c33-1aea-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate po |
| 68071-4224-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1aea-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate po |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4224-2 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4224 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240608_6285c4f2-c13b-49a9-e053-2991aa0a2b03.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-4224-2 | 68071422402 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-4224-2) | 2018-01-11 | 0000-00-00 | No | No | Current |