NDC 55289-505

Ranitidine

Ranitidine

Ranitidine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Ranitidine Hydrochloride.

Product ID55289-505_7c4adfd3-ed45-e2cb-e053-2991aa0a519d
NDC55289-505
Product TypeHuman Prescription Drug
Proprietary NameRanitidine
Generic NameRanitidine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1998-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA075165
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-505-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-505-30)
Marketing Start Date2009-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-505-60 [55289050560]

Ranitidine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-02
Marketing End Date2019-09-09

NDC 55289-505-30 [55289050530]

Ranitidine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-02
Marketing End Date2019-09-09

NDC 55289-505-14 [55289050514]

Ranitidine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075165
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-11-02
Marketing End Date2019-09-09

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:85f11b74-a88d-45a1-9ef1-6007e1bbedf7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198193
    • UPC Code
  • 0355289505600

    • 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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