Amoxicillin
- Product NDC
- 76420-838
- 11-digit product format
- 764200838
- Labeler code
- 76420
- Product ID
- 76420-838_203ead37-92bb-9348-e063-6294a90ab111
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA065256
- Marketing category
- ANDA
- Marketing start
- 2005-11-09
- Substance
- AMOXICILLIN
- Active strength
- 500 mg/1
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-838-01 | 76420083801 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-838-01) | 2024-08-21 | No | No | Historical |
| 76420-838-20 | 76420083820 | 20 TABLET, FILM COATED in 1 BOTTLE (76420-838-20) | 2024-08-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amoxicillin | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2024-08-21 | HUMAN PRESCRIPTION DRUG LABEL | 2 |