Clarithromycin
- Product NDC
- 82804-069
- 11-digit product format
- 828040069
- Labeler code
- 82804
- Product ID
- 82804-069_28f60574-4ecd-441c-aebe-5b1d18033ef6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065136
- Marketing category
- ANDA
- Marketing start
- 2005-08-25
- Substance
- CLARITHROMYCIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| H1250JIK0A | CLARITHROMYCIN | 81103-11-9 | CLARITHROMYCIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-069-20 | 82804006920 | 20 TABLET in 1 BOTTLE (82804-069-20) | 20 tablet | 2024-02-01 | No | No | Historical |
| 82804-069-30 | 82804006930 | 30 TABLET in 1 BOTTLE (82804-069-30) | 30 tablet | 2024-02-01 | No | No | Historical |
| 82804-069-60 | 82804006960 | 60 TABLET in 1 BOTTLE (82804-069-60) | 60 tablet | 2024-02-01 | No | No | Historical |
| 82804-069-90 | 82804006990 | 90 TABLET in 1 BOTTLE (82804-069-90) | 90 tablet | 2024-02-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Clarithromycin | Proficient Rx LP | 2024-02-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |