Tribenzor
- Product NDC
- 65597-115
- 11-digit product format
- 655970115
- Labeler code
- 65597
- Product ID
- 65597-115_d38366c2-56f0-47d2-add1-f87c9f5d6f30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Daiichi Sankyo, Inc.
- Application
- NDA200175
- Marketing category
- NDA
- Marketing start
- 2010-07-31
- Marketing end
- 2023-07-31
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Active strength
- 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [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 |
|---|
| 65597-115-07 | 65597011507 | 7 TABLET, FILM COATED in 1 BOTTLE (65597-115-07) | | 2010-07-31 | 0000-00-00 | No | No | Current |
| 65597-115-10 | 65597011510 | 10 BLISTER PACK in 1 BOX (65597-115-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2010-07-31 | 0000-00-00 | No | No | Current |
| 65597-115-30 | 65597011530 | 30 TABLET, FILM COATED in 1 BOTTLE (65597-115-30) | | 2010-07-31 | 0000-00-00 | No | No | Current |
| 65597-115-70 | 65597011570 | 7 TABLET, FILM COATED in 1 BLISTER PACK (65597-115-70) | | 2010-07-31 | 0000-00-00 | No | No | Current |
| 65597-115-90 | 65597011590 | 90 TABLET, FILM COATED in 1 BOTTLE (65597-115-90) | | 2010-07-31 | 0000-00-00 | No | No | Current |