FDA.reportPublic FDA data

Azor

Product NDC
0713-0872
11-digit product format
007130872
Labeler code
0713
Product ID
0713-0872_00491aef-cf0c-eeb3-e063-6394a90a716d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate and olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA022100
Marketing category
NDA
Marketing start
2022-09-01
Substance
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength
5; 40 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
OLMESARTAN MEDOXOMIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD, 864V2Q084H
Rxcui730861, 730866, 730869, 730872, 744624, 744628, 744632, 744636

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0713-0872-302024-01-30C16284748780-11030e365-53f2-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0872-30Azor30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0872-30EA - Each0713-08727140f971-3e26-4921-a783-9a17dacdb39e12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0872AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20230713_c5535406-b63b-49aa-88b9-169aaf0ed08e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
730861amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral TabletPSNc5535406-b63b-49aa-88b9-169aaf0ed08e4
730866amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral TabletPSNc5535406-b63b-49aa-88b9-169aaf0ed08e4
730869amLODIPine 5 MG / olmesartan medoxomil 20 MG Oral TabletPSNc5535406-b63b-49aa-88b9-169aaf0ed08e4
730872amLODIPine 5 MG / olmesartan medoxomil 40 MG Oral TabletPSNc5535406-b63b-49aa-88b9-169aaf0ed08e4
744624Azor 10 MG / 20 MG Oral TabletPSNc5535406-b63b-49aa-88b9-169aaf0ed08e4
744628Azor 10 MG / 40 MG Oral TabletPSNc5535406-b63b-49aa-88b9-169aaf0ed08e4
744632Azor 5 MG / 20 MG Oral TabletPSNc5535406-b63b-49aa-88b9-169aaf0ed08e4
744636Azor 5 MG / 40 MG Oral TabletPSNc5535406-b63b-49aa-88b9-169aaf0ed08e4
744624amlodipine 10 MG / olmesartan medoxomil 20 MG Oral Tablet [Azor]SBDc5535406-b63b-49aa-88b9-169aaf0ed08e4
744628amlodipine 10 MG / olmesartan medoxomil 40 MG Oral Tablet [Azor]SBDc5535406-b63b-49aa-88b9-169aaf0ed08e4
744632amlodipine 5 MG / olmesartan medoxomil 20 MG Oral Tablet [Azor]SBDc5535406-b63b-49aa-88b9-169aaf0ed08e4
744636amlodipine 5 MG / olmesartan medoxomil 40 MG Oral Tablet [Azor]SBDc5535406-b63b-49aa-88b9-169aaf0ed08e4
730861amlodipine 10 MG / olmesartan medoxomil 20 MG Oral TabletSCDc5535406-b63b-49aa-88b9-169aaf0ed08e4
730866amlodipine 10 MG / olmesartan medoxomil 40 MG Oral TabletSCDc5535406-b63b-49aa-88b9-169aaf0ed08e4
730869amlodipine 5 MG / olmesartan medoxomil 20 MG Oral TabletSCDc5535406-b63b-49aa-88b9-169aaf0ed08e4
730872amlodipine 5 MG / olmesartan medoxomil 40 MG Oral TabletSCDc5535406-b63b-49aa-88b9-169aaf0ed08e4
730861amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
730866amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
730869amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
730872amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
744624Azor (amlodipine 10 MG (amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG) Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
744628Azor (amlodipine 10 MG (amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG) Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
744632Azor (amlodipine 5 MG (amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG) Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
744636Azor (amlodipine 5 MG (amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG) Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
744624Azor 10/20 Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
744628Azor 10/40 Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
744632Azor 5/20 MG Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
744636Azor 5/40 Oral TabletSYc5535406-b63b-49aa-88b9-169aaf0ed08e4
730861amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral TabletPSN132cca8f-48a2-2516-e063-6394a90a5f323
730866amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral TabletPSN132cca8f-48a2-2516-e063-6394a90a5f323
730869amLODIPine 5 MG / olmesartan medoxomil 20 MG Oral TabletPSN132cca8f-48a2-2516-e063-6394a90a5f323
730872amLODIPine 5 MG / olmesartan medoxomil 40 MG Oral TabletPSN132cca8f-48a2-2516-e063-6394a90a5f323
730861amlodipine 10 MG / olmesartan medoxomil 20 MG Oral TabletSCD132cca8f-48a2-2516-e063-6394a90a5f323
730866amlodipine 10 MG / olmesartan medoxomil 40 MG Oral TabletSCD132cca8f-48a2-2516-e063-6394a90a5f323
730869amlodipine 5 MG / olmesartan medoxomil 20 MG Oral TabletSCD132cca8f-48a2-2516-e063-6394a90a5f323
730872amlodipine 5 MG / olmesartan medoxomil 40 MG Oral TabletSCD132cca8f-48a2-2516-e063-6394a90a5f323
730861amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY132cca8f-48a2-2516-e063-6394a90a5f323
730866amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY132cca8f-48a2-2516-e063-6394a90a5f323
730869amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG Oral TabletSY132cca8f-48a2-2516-e063-6394a90a5f323
730872amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG Oral TabletSY132cca8f-48a2-2516-e063-6394a90a5f323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0713-0872-300071308723030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0872-30) 2022-09-010000-00-00NoNoCurrent