Amoxicillin
- Product NDC
- 76420-819
- 11-digit product format
- 764200819
- Labeler code
- 76420
- Product ID
- 76420-819_1bc435f9-12b8-ccff-e063-6294a90a951a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA065378
- Marketing category
- ANDA
- Marketing start
- 2007-03-26
- Substance
- AMOXICILLIN
- Active strength
- 400 mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Sample | Exclude flag | Status |
|---|
| 76420-819-01 | 76420081901 | 100 mL in 1 BOTTLE (76420-819-01) | 100 ml | 2024-06-26 | No | No | Historical |
| 76420-819-50 | 76420081950 | 50 mL in 1 BOTTLE (76420-819-50) | 50 ml | 2024-06-26 | No | No | Historical |
| 76420-819-75 | 76420081975 | 75 mL in 1 BOTTLE (76420-819-75) | 75 ml | 2024-06-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amoxicillin | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2024-06-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |