NDC 52565-096

ZANTAC

Ranitidine Hydrochloride

ZANTAC is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Ranitidine Hydrochloride.

Product ID52565-096_3fe54dc0-fc84-4428-89ba-eaf09a317a88
NDC52565-096
Product TypeHuman Prescription Drug
Proprietary NameZANTAC
Generic NameRanitidine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2017-01-18
Marketing CategoryNDA / NDA
Application NumberNDA019090
Labeler NameTeligent Pharma, Inc.
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength25 mg/mL
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52565-096-01

1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (52565-096-01) > 40 mL in 1 VIAL, PHARMACY BULK PACKAGE
Marketing Start Date2017-01-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-096-01 [52565009601]

ZANTAC INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019090
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-01-18
Marketing End Date2019-09-12

NDC 52565-096-04 [52565009604]

ZANTAC INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019090
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-18
Marketing End Date2020-05-21

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE25 mg/mL

OpenFDA Data

SPL SET ID:95dc4515-7690-4881-ae14-9f8655a68dfe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312772
  • 104084

    • Pharmacological Class

    • Histamine H2 Receptor Antagonists [MoA]
    • Histamine-2 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "ZANTAC" or generic name "Ranitidine Hydrochloride"

    NDCBrand NameGeneric Name
    0173-0393ZANTACranitidine hydrochloride
    76413-317ZantacZantac
    52565-101ZANTACZANTAC
    52565-096ZANTACZANTAC
    52565-102ZANTACZANTAC
    21130-003Acid ReducerRanitidine Hydrochloride
    46084-031APTIDINERANITIDINE HYDROCHLORIDE
    0440-2300RanitidineRanitidine Hydrochloride
    11822-4727RanitidineRanitidine Hydrochloride
    11822-6051RanitidineRanitidine Hydrochloride
    11822-6052RanitidineRanitidine Hydrochloride
    11822-6107RanitidineRanitidine Hydrochloride
    37808-302RanitidineRanitidine Hydrochloride
    37808-303RanitidineRanitidine Hydrochloride
    41163-353RanitidineRanitidine Hydrochloride
    43353-952RanitidineRanitidine Hydrochloride
    49035-117RanitidineRanitidine Hydrochloride
    49035-353RanitidineRanitidine Hydrochloride
    50090-4353RanitidineRanitidine Hydrochloride
    0615-1354Ranitidine HydrochlorideRanitidine Hydrochloride
    0781-1883Ranitidine HydrochlorideRanitidine Hydrochloride
    0781-1884Ranitidine HydrochlorideRanitidine Hydrochloride
    0781-2855Ranitidine HydrochlorideRanitidine Hydrochloride
    0781-2865Ranitidine HydrochlorideRanitidine Hydrochloride
    15127-711Ranitidine HydrochlorideRanitidine Hydrochloride
    21695-337Ranitidine HydrochlorideRanitidine Hydrochloride
    21695-338Ranitidine HydrochlorideRanitidine Hydrochloride
    42291-735Ranitidine HydrochlorideRanitidine Hydrochloride
    42291-736Ranitidine HydrochlorideRanitidine Hydrochloride
    42291-766Ranitidine HydrochlorideRanitidine Hydrochloride
    42291-767Ranitidine HydrochlorideRanitidine Hydrochloride
    51079-879Ranitidine HydrochlorideRanitidine Hydrochloride
    51407-097Ranitidine HydrochlorideRanitidine Hydrochloride
    51407-098Ranitidine HydrochlorideRanitidine Hydrochloride
    41167-0310Zantac 150Ranitidine Hydrochloride
    41167-0320Zantac 150Ranitidine Hydrochloride
    41167-0300Zantac 75Ranitidine Hydrochloride

    Trademark Results [ZANTAC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZANTAC
    ZANTAC
    74504090 1967301 Live/Registered
    BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
    1994-03-23
    ZANTAC
    ZANTAC
    74504089 1965943 Live/Registered
    BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
    1994-03-23
    ZANTAC
    ZANTAC
    74136868 1865140 Dead/Cancelled
    GLAXO GROUP LIMITED
    1991-02-06
    ZANTAC
    ZANTAC
    74103235 1685021 Live/Registered
    CHATTEM, INC.
    1990-10-04
    ZANTAC
    ZANTAC
    74010111 not registered Dead/Abandoned
    GLAXO GROUP LIMITED
    1989-12-12
    ZANTAC
    ZANTAC
    73804230 not registered Dead/Abandoned
    GLAXO GROUP LIMITED
    1989-06-05
    ZANTAC
    ZANTAC
    73337687 1230799 Dead/Cancelled
    Glaxo Group Limited
    1981-11-18
    ZANTAC
    ZANTAC
    73289054 1220525 Live/Registered
    Glaxo Group Limited
    1980-12-09
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