Hydrochlorothiazide
HYDROCHLOROTHIAZIDE TABLETS USP
Approved
Approval ID
9cbdc7a7-2e87-4ba0-b5e5-70e15caae63d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-055
Application NumberANDA040702
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2009
FDA Product Classification
INGREDIENTS (7)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HydrochlorothiazideActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT