Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
- Product NDC
- 57664-800
- 11-digit product format
- 576640800
- Labeler code
- 57664
- Product ID
- 57664-800_e97e6623-9454-4d2f-8cbc-d84db5f0b5ce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA200175
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-10-26
- Marketing end
- 2024-05-31
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
- Active strength
- 10 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57664-800-83 | 57664080083 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-800-83) | 2016-10-26 | 0000-00-00 | No | No | Current |
| 57664-800-99 | 57664080099 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-800-99) | 2016-10-26 | 0000-00-00 | No | No | Current |