NDC 61919-339

RANITIDINE

Ranitidine

RANITIDINE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Ranitidine Hydrochloride.

Product ID61919-339_5b3542a3-7e9f-a5ee-e053-2991aa0aa1c3
NDC61919-339
Product TypeHuman Prescription Drug
Proprietary NameRANITIDINE
Generic NameRanitidine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA078542
Labeler NameDIRECT RX
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength150 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-339-60

60 TABLET, FILM COATED in 1 BOTTLE (61919-339-60)
Marketing Start Date2017-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-339-30 [61919033930]

RANITIDINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078542
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-07
Marketing End Date2019-12-18

NDC 61919-339-60 [61919033960]

RANITIDINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078542
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-10
Marketing End Date2019-12-18

NDC 61919-339-90 [61919033990]

RANITIDINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078542
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-12
Marketing End Date2019-12-18

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE150 mg/1

OpenFDA Data

SPL SET ID:5b3542a3-7e9e-a5ee-e053-2991aa0aa1c3
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
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