Amoxicillin and Clavulanate Potassium
- Product NDC
- 43858-601
- 11-digit product format
- 438580601
- Labeler code
- 43858
- Product ID
- 43858-601_695710cf-342f-4ecd-822c-12b843ddb9b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz GmbH
- Application
- ANDA065063
- Marketing category
- ANDA
- Marketing start
- 2015-10-21
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43858-601-13 | 43858060113 | 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (43858-601-13) | 2015-10-21 | 0000-00-00 | No | No | Current |
| 43858-601-20 | 43858060120 | 20 TABLET, FILM COATED in 1 BOTTLE (43858-601-20) | 2015-10-21 | 0000-00-00 | No | No | Current |