Amoxicillin
- Product NDC
- 53002-1369
- 11-digit product format
- 530021369
- Labeler code
- 53002
- Product ID
- 53002-1369_1bec764a-9031-406d-9840-745732975b38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA065378
- Marketing category
- ANDA
- Marketing start
- 2007-03-26
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 400 mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 804826J2HU | AMOXICILLIN | 61336-70-7 | AMOXICILLIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-1369-3 | 53002136903 | 100 mL in 1 BOTTLE (53002-1369-3) | 100 ml | 2018-10-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amoxicillin | RPK Pharmaceuticals, Inc. | 2023-06-07 | HUMAN PRESCRIPTION DRUG LABEL | 8 |