Triamterene and Hydrochlorothiazide
Triamterene and Hydrochlorothiazide Capsules, USP
Approved
Approval ID
21c7fb80-4f9f-41eb-bebb-eda511980284
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 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.
Triamterene and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-839
Application NumberANDA074821
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamterene and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2008
FDA Product Classification
INGREDIENTS (19)
triamtereneActive
Quantity: 37.5 mg in 1 1
Code: WS821Z52LQ
Classification: ACTIB
citric acidInactive
Code: 2968PHW8QP
Classification: IACT
hydrochlorothiazideActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
glycineInactive
Code: TE7660XO1C
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT