Ranitidine Immediate Release: Package Insert and Label Information (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only

NDC 51407-244-18

Ranitidine Tablets, USP

150 mg

180 Tablets

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA 93012 USA

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC 51407-245-30

Ranitidine Tablets, USP

300 mg

30 Tablets

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA 93012 USA

51407-245-30LB RANITIDINE 300 MG TABS.jpg
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RANITIDINE IMMEDIATE RELEASE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-244(NDC:64380-936)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
HYPROMELLOSES
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
Product Characteristics
Color brown Score no score
Shape ROUND (circular, biconvex, beveled edge) Size 10mm
Flavor Imprint Code S;429
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-244-60 60 TABLET in 1 BOTTLE None
2 NDC:51407-244-18 180 TABLET in 1 BOTTLE None
3 NDC:51407-244-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205512 08/22/2016
RANITIDINE IMMEDIATE RELEASE ranitidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-245(NDC:64380-937)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
HYPROMELLOSES
TITANIUM DIOXIDE
TRIACETIN
FERRIC OXIDE RED
Product Characteristics
Color brown Score no score
Shape ROUND (circular, biconvex, beveled edge) Size 13mm
Flavor Imprint Code S;430
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-245-25 250 TABLET in 1 BOTTLE None
2 NDC:51407-245-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205512 08/22/2016
Labeler — Golden State Medical Supply Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply Inc. 603184490 relabel (51407-244), repack (51407-245), relabel (51407-245), repack (51407-244)

Revised: 09/2019 Golden State Medical Supply Inc.

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