Amlodipine and olmesartan medoxomil
- Product NDC
- 68382-928
- 11-digit product format
- 683820928
- Labeler code
- 68382
- Product ID
- 68382-928_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
- 10 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-928-01 | 68382092801 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-928-01) | | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-928-05 | 68382092805 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-928-05) | | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-928-06 | 68382092806 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-928-06) | | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-928-10 | 68382092810 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-928-10) | | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-928-16 | 68382092816 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-928-16) | | 2018-01-04 | 0000-00-00 | No | No | Current |
| 68382-928-77 | 68382092877 | 10 BLISTER PACK in 1 CARTON (68382-928-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-928-30) | 10 blister pack | 2018-01-04 | 0000-00-00 | No | No | Current |