NDC Code(s) : 63629-3639-1, 63629-3639-2, 63629-3639-3, 63629-3639-4
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NizatidineNizatidine CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-3639(NDC:55111-310)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIZATIDINE(UNII: P41PML4GHR)
(NIZATIDINE - UNII:P41PML4GHR) 		NIZATIDINE150 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium(UNII: M28OL1HH48)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STARCH, CORN(UNII: O8232NY3SJ)
dimethicone(UNII: 92RU3N3Y1O)
talc(UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Titanium Dioxide(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
D&C red no. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C red no. 40(UNII: WZB9127XOA)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Butyl Alcohol(UNII: 8PJ61P6TS3)
Propylene Glycol(UNII: 6DC9Q167V3)
FD&C blue no. 2(UNII: L06K8R7DQK)
ALCOHOL(UNII: 3K9958V90M)
Product Characteristics
Color PINK (pink opaque cap), YELLOW (yellow opaque body) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code RDY;310
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-3639-1 60 in 1 BOTTLE Type 0: Not a Combination Product15/09/2005
2NDC:63629-3639-2 30 in 1 BOTTLE Type 0: Not a Combination Product15/09/2005
3NDC:63629-3639-3 56 in 1 BOTTLE Type 0: Not a Combination Product15/09/2005
4NDC:63629-3639-4 6 in 1 BOTTLE Type 0: Not a Combination Product15/10/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077314 09/15/2005

PRINCIPAL DISPLAY PANEL

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