Amlodipine and olmesartan medoxomil
- Product NDC
- 68382-927
- 11-digit product format
- 683820927
- Labeler code
- 68382
- Product ID
- 68382-927_cf71e29b-40b3-470b-b837-5a4bdd6f9409
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and olmesartan medoxomil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA207771
- Marketing category
- ANDA
- Marketing start
- 2018-01-04
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
- Active strength
- 5 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]
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-927-01 | 68382092701 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-927-01) | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-927-05 | 68382092705 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-927-05) | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-927-06 | 68382092706 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-927-06) | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-927-10 | 68382092710 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-927-10) | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-927-16 | 68382092716 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-927-16) | 2018-01-04 | 0000-00-00 | No | No | Current |