Amoxicillin and Clavulanate Potassium
- Product NDC
- 68071-1619
- 11-digit product format
- 680711619
- Labeler code
- 68071
- Product ID
- 68071-1619_1d4c3bbf-43f9-8590-e063-6294a90adebb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA065191
- Marketing category
- ANDA
- Marketing start
- 2007-12-01
- Substance
- AMOXICILLIN; CLAVULANIC ACID
- Active strength
- 400; 57 mg/5mL; mg/5mL
- 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 | 400 mg/5mL |
| CLAVULANIC ACID | 57 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, 23521W1S24 |
| Rxcui | 617430 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-1619-1 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-5aa2-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP . Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP Initial U.S. Approval: 1984 Rx Only |
| 68071-1619-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-5aa2-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP . Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP Initial U.S. Approval: 1984 Rx Only |
| 68071-1619-1 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-5aa2-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP . Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP Initial U.S. Approval: 1984 Rx Only |
| 68071-1619-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5aa2-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP safely and effectively. See full prescribing information for Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP . Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP Initial U.S. Approval: 1984 Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1619-1 | Amoxicillin and Clavulanate Potassium | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1619 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240716_5d074fe6-1ee0-40d8-e053-2a91aa0a7549.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 |
|---|
| 68071-1619-1 | 68071161901 | 100 mL in 1 BOTTLE (68071-1619-1) | 100 ml | 2017-11-02 | 0000-00-00 | No | No | Current |