Hydrochlorothiazide
HYDROCHLOROTHIAZIDE TABLETS, USP 40-9079 Revised — January 2008 Rx only
Approved
Approval ID
e66b1c3c-9121-4e2a-a8c8-65b2e8c54f52
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 29, 2010
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 Code21695-537
Application NumberANDA040707
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2009
FDA Product Classification
INGREDIENTS (7)
HydrochlorothiazideActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
calcium stearateInactive
Code: 776XM7047L
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT