NDC 50383-051

Ranitidine

Ranitidine

Ranitidine is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Ranitidine Hydrochloride.

Product ID50383-051_4029ac91-63f2-4319-bd98-c80865fd4615
NDC50383-051
Product TypeHuman Prescription Drug
Proprietary NameRanitidine
Generic NameRanitidine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2011-03-22
Marketing CategoryANDA / ANDA
Application NumberANDA091078
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength15 mg/mL
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50383-051-04

118 mL in 1 BOTTLE (50383-051-04)
Marketing Start Date2011-03-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-051-10 [50383005110]

Ranitidine SOLUTION
Marketing CategoryANDA
Application NumberANDA091078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-07-31
Marketing End Date2017-12-15

NDC 50383-051-04 [50383005104]

Ranitidine SOLUTION
Marketing CategoryANDA
Application NumberANDA091078
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-22
Marketing End Date2017-12-15
Inactivation Date2020-01-31
Reactivation Date2020-05-19

NDC 50383-051-16 [50383005116]

Ranitidine SOLUTION
Marketing CategoryANDA
Application NumberANDA091078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-22
Marketing End Date2017-12-15
Inactivation Date2020-01-31
Reactivation Date2020-05-19

NDC 50383-051-12 [50383005112]

Ranitidine SOLUTION
Marketing CategoryANDA
Application NumberANDA091078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-22
Marketing End Date2017-12-15
Inactivation Date2020-01-31
Reactivation Date2020-05-19

NDC 50383-051-11 [50383005111]

Ranitidine SOLUTION
Marketing CategoryANDA
Application NumberANDA091078
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-22
Marketing End Date2017-12-15
Inactivation Date2020-01-31
Reactivation Date2020-05-19

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE15 mg/mL

OpenFDA Data

SPL SET ID:f7485b07-7ac0-44fe-a713-1e066c9043a8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 705610

    • Pharmacological Class

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

    Medicade Reported Pricing

    50383005116 RANITIDINE 15 MG/ML SYRUP

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    0121-0727RanitidineRANITIDINE
    0121-4727RanitidineRANITIDINE
    0172-4357RanitidineRanitidine
    0172-4358RanitidineRanitidine
    0363-0352RanitidineRanitidine
    0440-2300RanitidineRanitidine Hydrochloride
    0440-8300RanitidineRanitidine
    0440-8305RanitidineRanitidine
    0615-4513RanitidineRanitidine
    0615-4514RanitidineRanitidine
    0615-8021RanitidineRanitidine
    0781-6087RanitidineRanitidine
    0904-6349RanitidineRanitidine
    0904-6716RanitidineRanitidine
    0904-6921RanitidineRanitidine
    10544-056RanitidineRanitidine
    10544-438RanitidineRanitidine
    10544-516RanitidineRanitidine
    68071-2190RanitidineRanitidine
    68071-3162RanitidineRanitidine
    68071-3317RanitidineRanitidine
    68071-2185RanitidineRanitidine
    68071-3248RanitidineRanitidine
    68071-3165RanitidineRanitidine
    68151-1610RanitidineRanitidine
    68151-2890RanitidineRanitidine
    68462-248RanitidineRanitidine
    68462-249RanitidineRanitidine
    68788-6382RanitidineRanitidine
    68788-7101RanitidineRanitidine
    68788-7078RanitidineRanitidine
    68788-7388RanitidineRanitidine
    68788-9875RanitidineRanitidine
    68788-9874RanitidineRanitidine
    70408-141RANITIDINERANITIDINE
    70518-0222RanitidineRanitidine
    70518-0263RanitidineRanitidine
    70518-0093RanitidineRanitidine
    70518-0622RanitidineRanitidine
    70518-0873RanitidineRanitidine
    70518-0801RanitidineRanitidine
    70518-1361RanitidineRanitidine
    70518-1714RanitidineRanitidine
    70934-017RanitidineRanitidine
    71141-013RanitidineRanitidine
    71335-0394RanitidineRanitidine
    71335-0342RanitidineRanitidine
    71335-0363RanitidineRanitidine
    71821-001RanitidineRanitidine
    71821-002RanitidineRanitidine
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