Hydrochlorothiazide
HYDROCHLOROTHIAZIDE
Approved
Approval ID
9416208e-e3fe-4213-a4c1-2ea6ebdc5795
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0419
Application NumberANDA075907
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (7)
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0422
Application NumberANDA075907
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (6)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0662
Application NumberANDA075907
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2010
FDA Product Classification
INGREDIENTS (6)
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT