Lotrel
- Product NDC
- 55289-039
- 11-digit product format
- 552890039
- Labeler code
- 55289
- Product ID
- 55289-039_dcf4c306-c361-5b34-e053-2a95a90a824b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate and benazepril hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- NDA020364
- Marketing category
- NDA
- Marketing start
- 1995-03-03
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 55289-039-30 | 55289003930 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-039-30) | 30 capsule | 2011-10-10 | 0000-00-00 | No | No | Current |