NDC Code(s) : 54569-3967-0, 54569-3967-1
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Triamterene and HydrochlorothiazideTriamterene and Hydrochlorothiazide CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-3967(NDC:0527-1632)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMTERENE(UNII: WS821Z52LQ)
(TRIAMTERENE - UNII:WS821Z52LQ) 		TRIAMTERENE37.5 mg
HYDROCHLOROTHIAZIDE(UNII: 0J48LPH2TH)
(HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) 		HYDROCHLOROTHIAZIDE25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
POVIDONES(UNII: FZ989GH94E)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN(UNII: 2G86QN327L)
SHELLAC(UNII: 46N107B71O)
ALCOHOL(UNII: 3K9958V90M)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
METHYL ALCOHOL(UNII: Y4S76JWI15)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code LANNETT;1632
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-3967-030 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:54569-3967-1100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201407 12/12/2011

PRINCIPAL DISPLAY PANEL

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