Ranitidine (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 MG
(click image for full-size original)

Label 150 mg

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

300 mg
(click image for full-size original)
Label 300 mg 300 mg
RANITIDINE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-253
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
Product Characteristics
Color ORANGE Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code IP;253
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-253-60 60 TABLET in 1 BOTTLE None
2 NDC:53746-253-01 100 TABLET in 1 BOTTLE None
3 NDC:53746-253-18 180 TABLET in 1 BOTTLE None
4 NDC:53746-253-05 500 TABLET in 1 BOTTLE None
5 NDC:53746-253-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077824 12/16/2009
RANITIDINE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53746-254
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 300 mg
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE (Biconvex) Size 17mm
Flavor Imprint Code IP;254
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53746-254-30 30 TABLET in 1 BOTTLE None
2 NDC:53746-254-01 100 TABLET in 1 BOTTLE None
3 NDC:53746-254-02 250 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077824 12/16/2009
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals, LLC 969951594 PACK (53746-253), PACK (53746-254), REPACK (53746-253), REPACK (53746-254)

Revised: 05/2019 Amneal Pharmaceuticals of New York LLC

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