Hydrochlorothiazide
HYDROCHLOROTHIAZIDE CAPSULES
Approved
Approval ID
09bce4c4-96af-4b8b-8d92-86e330fef348
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
Products 1
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 Code67296-0556
Application NumberANDA075907
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2011
FDA Product Classification
INGREDIENTS (12)
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT