NDC Code(s) : 49349-298-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Terazosin HydrochlorideTerazosin Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-298
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TERAZOSIN HYDROCHLORIDE(UNII: D32S14F082)
(TERAZOSIN - UNII:8L5014XET7) 		TERAZOSIN5 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN(UNII: 2G86QN327L)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color orange (Bright Orange Opaque) Score no score
Shape CAPSULE Size 15 mm
Flavor Imprint Code TL;385
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-298-0230 in 1 BLISTER PACK Type 0: Not a Combination Product19/01/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075317 01/19/2010 03/10/2017

PRINCIPAL DISPLAY PANEL

DRUG: Terazosin

GENERIC: Terazosin Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 49349-298-02

COLOR: orange

SHAPE: CAPSULE

SCORE: No score

SIZE: 16 mm

IMPRINT: TL385

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • Terazosin Hydrochloride 5mg in 1

INACTIVE INGREDIENT(S):

  • D&c Yellow No. 10
  • Silicon Dioxide
  • Fd&c Red No. 40
  • D&c Red No. 28
  • Starch, Corn
  • Gelatin
  • Lactose Monohydrate
  • Magnesium Stearate
  • Sodium Lauryl Sulfate
  • Titanium Dioxide

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