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- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 40 mL Vial Container Label
NDC 72785-0001-1
Ranitidine Injection USP
1000 mg/40 mL
(25 mg/mL*)
40-mL Pharmacy Bulk package – Not for Direct Infusion
Sterile
Rx only
Zydus pharmaceuticals
PRINCIPAL DISPLAY PANEL - 40 mL Vial Carton Label
NDC 72785-0001-1
Ranitidine Injection USP
1000 mg/40 mL
(25 mg/mL*)
40-mL Pharmacy Bulk Package – Not for Direct Infusion
Sterile
Rx only
Zydus pharmaceuticals
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INGREDIENTS AND APPEARANCE
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72785-0001 Route of Administration INTRAMUSCULAR, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOL (UNII: 339NCG44TV) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) Product Characteristics Color YELLOW (colorless to yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72785-0001-1 1 in 1 CARTON 02/21/2019 1 40 mL in 1 VIAL, PHARMACY BULK PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091534 02/21/2019 Labeler - Cadila Healthcare Limited (873671928) Registrant - Cadila Healthcare Limited (873671928) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 873671928 ANALYSIS(72785-0001) , MANUFACTURE(72785-0001)