Amoxicillin and Clavulanate Potassium
- Product NDC
- 45865-928
- 11-digit product format
- 458650928
- Labeler code
- 45865
- Product ID
- 45865-928_9adcc6d3-28c0-32d2-e053-2995a90a24a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- medsource pharmaceuticals
- Application
- ANDA065162
- Marketing category
- ANDA
- Marketing start
- 2004-09-23
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 600 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-928-01 | Amoxicillin and Clavulanate Potassium | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-928 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 1 package rows | 20191230_9adcc6d3-28bf-32d2-e053-2995a90a24a1.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 |
|---|
| 45865-928-01 | 45865092801 | 75 mL in 1 BOTTLE (45865-928-01) | 75 ml | 2018-12-12 | 0000-00-00 | No | No | Current |