Clarithromycin Extended-Release
- Product NDC
- 72763-100
- 11-digit product format
- 727630100
- Labeler code
- 72763
- Product ID
- 72763-100_7a5cadda-1ece-4894-8f05-a0f35c984998
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLARITHROMYCIN
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Estreno Pharmaceuticals, LLC
- Application
- ANDA203243
- Marketing category
- ANDA
- Marketing start
- 2018-01-01
- Marketing end
- 0000-00-00
- Substance
- CLARITHROMYCIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record