Hydrochlorothiazide
HYDROCHLOROTHIAZIDE TABLETS, USPRx Only
Approved
Approval ID
afbb9a0e-c22f-4133-8015-b4b2ab4d32e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2020
Manufacturers
FDA
Oxford Pharmaceuticals, LLC
DUNS: 079638266
Products 2
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 Code69584-362
Application NumberANDA087068
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 10, 2020
FDA Product Classification
INGREDIENTS (6)
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
HydrochlorothiazideActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69584-361
Application NumberANDA087059
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 10, 2020
FDA Product Classification
INGREDIENTS (6)
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
HydrochlorothiazideActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Microcrystalline Cellulose 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT