Amoxicillin and Clavulanate Potassium
- Product NDC
- 68788-8000
- 11-digit product format
- 687888000
- Labeler code
- 68788
- Product ID
- 68788-8000_db2f8359-bd14-4ee6-9f4d-cce4f3a1cbe3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA065066
- Marketing category
- ANDA
- Marketing start
- 2021-08-10
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 200 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8000 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] | 5 | Legacy NDC | 20250125_51ee76f6-b699-4e50-b7a9-0477580d1f14.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8000-1 | 68788800001 | 100 mL in 1 BOTTLE (68788-8000-1) | 100 ml | 2021-08-10 | 0000-00-00 | No | No | Current |