Azor
- Product NDC
- 65597-111
- 11-digit product format
- 655970111
- Labeler code
- 65597
- Product ID
- 65597-111_d5485e0f-7c18-4073-91f6-0890243d9bd6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate and olmesartan medoxomil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Daiichi Sankyo Inc.
- Application
- NDA022100
- Marketing category
- NDA
- Marketing start
- 2007-09-26
- Marketing end
- 2024-08-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65597-111-07 | 65597011107 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-111-07) | | 2007-09-26 | 0000-00-00 | No | No | Current |
| 65597-111-10 | 65597011110 | 10 BLISTER PACK in 1 BOX (65597-111-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2007-09-26 | 0000-00-00 | No | No | Current |
| 65597-111-11 | 65597011111 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-111-11) | | 2007-09-26 | 0000-00-00 | No | No | Current |
| 65597-111-30 | 65597011130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-111-30) | | 2007-09-26 | 0000-00-00 | No | No | Current |
| 65597-111-90 | 65597011190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-111-90) | | 2007-09-26 | 0000-00-00 | No | No | Current |