Azor
- Product NDC
- 65597-113
- 11-digit product format
- 655970113
- Labeler code
- 65597
- Product ID
- 65597-113_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
- 2025-02-28
- 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| OLMESARTAN MEDOXOMIL | ACTIVE INGREDIENT | 6M97XTV3HD | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| OLMESARTAN | ACTIVE MOIETY | 8W1IQP3U10 | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65597-113-07 | 65597011307 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-113-07) | | 2007-09-26 | 0000-00-00 | No | No | Current |
| 65597-113-10 | 65597011310 | 10 BLISTER PACK in 1 BOX (65597-113-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2007-09-26 | 0000-00-00 | No | No | Current |
| 65597-113-11 | 65597011311 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-113-11) | | 2007-09-26 | 0000-00-00 | No | No | Current |
| 65597-113-30 | 65597011330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-113-30) | | 2007-09-26 | 0000-00-00 | No | No | Current |
| 65597-113-90 | 65597011390 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-113-90) | | 2007-09-26 | 0000-00-00 | No | No | Current |