NDC 70518-0093

Ranitidine

Ranitidine

Ranitidine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Ranitidine Hydrochloride.

Product ID70518-0093_81d37227-a117-3f1f-e053-2991aa0a4aaf
NDC70518-0093
Product TypeHuman Prescription Drug
Proprietary NameRanitidine
Generic NameRanitidine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-12-29
Marketing CategoryANDA / ANDA
Application NumberANDA077824
Labeler NameREMEDYREPACK INC.
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength150 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0093-2

60 TABLET in 1 BOTTLE, PLASTIC (70518-0093-2)
Marketing Start Date2017-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0093-2 [70518009302]

Ranitidine TABLET
Marketing CategoryANDA
Application NumberANDA077824
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-05
Marketing End Date2018-09-10

NDC 70518-0093-1 [70518009301]

Ranitidine TABLET
Marketing CategoryANDA
Application NumberANDA077824
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-04
Marketing End Date2018-12-14

NDC 70518-0093-0 [70518009300]

Ranitidine TABLET
Marketing CategoryANDA
Application NumberANDA077824
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-29
Marketing End Date2018-10-20

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE150 mg/1

OpenFDA Data

SPL SET ID:47504e7f-8efe-4a63-ae2b-04fca35be25e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198191
  • Pharmacological Class

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

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.