olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Tablets, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
44dc874b-4377-46eb-ae32-8d84c9c4d4ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-2238
Application NumberANDA206137
Product Classification
M
Marketing Category
C73584
G
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2021
FDA Product Classification
INGREDIENTS (12)
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT