AMLODIPINE BESYLATE
- Product NDC
- 0615-8282
- 11-digit product format
- 006158282
- Labeler code
- 0615
- Product ID
- 0615-8282_88f5a456-f60e-49ce-92fa-cb7e82f7624b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA077516
- Marketing category
- ANDA
- Marketing start
- 2011-04-15
- Marketing end
- 2024-04-30
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8282-05 | 00615828205 | 15 TABLET in 1 BLISTER PACK (0615-8282-05) | 15 tablet | 2020-02-17 | 2024-04-30 | No | No | Current |
| 0615-8282-30 | 00615828230 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8282-30) > 5 TABLET in 1 BLISTER PACK | 6 blister pack | 2019-04-04 | 2024-04-30 | No | No | Current |
| 0615-8282-39 | 00615828239 | 30 TABLET in 1 BLISTER PACK (0615-8282-39) | 30 tablet | 2019-03-18 | 2024-04-30 | No | No | Current |