NDC 67457-397

Ranitidine

Ranitidine

Ranitidine is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Ranitidine Hydrochloride.

Product ID67457-397_0ce9a646-f63d-4b96-bbbc-4edc4da811d2
NDC67457-397
Product TypeHuman Prescription Drug
Proprietary NameRanitidine
Generic NameRanitidine
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA079076
Labeler NameMylan Institutional LLC
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength25 mg/mL
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-397-99

10 VIAL in 1 CARTON (67457-397-99) > 2 mL in 1 VIAL (67457-397-20)
Marketing Start Date2018-08-17
Marketing End Date2021-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-397-99 [67457039799]

Ranitidine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA079076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-08-17
Marketing End Date2021-06-30

NDC 67457-397-20 [67457039720]

Ranitidine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA079076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-19
Marketing End Date2021-06-30

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE25 mg/mL

OpenFDA Data

SPL SET ID:cac737ca-fb4d-4e18-b3a9-af660d565254
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312772
  • 1859553
  • Pharmacological Class

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