Ranitidine (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ran150
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 ct.
(click image for full-size original)

RANITIDINE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-651(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:67046-651-60 60 TABLET in 1 BLISTER PACK None
2 NDC:67046-651-30 30 TABLET in 1 BLISTER PACK None
3 NDC:67046-651-07 7 TABLET in 1 BLISTER PACK None
4 NDC:67046-651-14 14 TABLET in 1 BLISTER PACK None
5 NDC:67046-651-15 15 TABLET in 1 BLISTER PACK None
6 NDC:67046-651-20 20 TABLET in 1 BLISTER PACK None
7 NDC:67046-651-21 21 TABLET in 1 BLISTER PACK None
8 NDC:67046-651-28 28 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077824 06/30/2010
RANITIDINE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67046-652(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:67046-652-30 30 TABLET in 1 BLISTER PACK None
2 NDC:67046-652-07 7 TABLET in 1 BLISTER PACK None
3 NDC:67046-652-14 14 TABLET in 1 BLISTER PACK None
4 NDC:67046-652-15 15 TABLET in 1 BLISTER PACK None
5 NDC:67046-652-20 20 TABLET in 1 BLISTER PACK None
6 NDC:67046-652-21 21 TABLET in 1 BLISTER PACK None
7 NDC:67046-652-28 28 TABLET in 1 BLISTER PACK None
8 NDC:67046-652-60 60 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077824 09/27/2017
Labeler — Contract Pharmacy Services-PA (945429777)
Establishment
Name Address ID/FEI Operations
Coupler Enterprises Inc. 945429777 repack (67046-651), repack (67046-652)

Revised: 12/2018 Contract Pharmacy Services-PA

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