NDC 49999-428

Ranitidine

Ranitidine

Ranitidine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Ranitidine Hydrochloride.

Product ID49999-428_3aad91ae-a22e-4fc1-8779-ab58270b2e97
NDC49999-428
Product TypeHuman Prescription Drug
Proprietary NameRanitidine
Generic NameRanitidine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-11-19
Marketing CategoryANDA / ANDA
Application NumberANDA078542
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49999-428-30

30 TABLET, FILM COATED in 1 BOTTLE (49999-428-30)
Marketing Start Date2008-11-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-428-90 [49999042890]

Ranitidine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078542
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-19
Marketing End Date2019-10-11

NDC 49999-428-60 [49999042860]

Ranitidine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078542
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-19
Marketing End Date2019-12-31

NDC 49999-428-30 [49999042830]

Ranitidine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078542
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-19

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:9d144e79-dbf6-412b-8ca3-27adc483a458
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198193

    • 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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