Amoxicillin and Clavulanate Potassium
- Product NDC
- 69452-335
- 11-digit product format
- 694520335
- Labeler code
- 69452
- Product ID
- 69452-335_3d370466-2b90-4d0b-9bf8-6297353d18ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA065066
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 400 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69452-335 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [BIONPHARMA INC.] | 5 | Legacy NDC | 20240514_80daca9e-1539-4f25-911f-b8868438ced8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69452-335-43 | 69452033543 | 100 mL in 1 BOTTLE (69452-335-43) | 100 ml | 2022-08-01 | 0000-00-00 | No | No | Current |