NDC 45865-374

Nizatidine

Nizatidine

Nizatidine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Nizatidine.

Product ID45865-374_1d6161e3-2dda-5446-e054-00144ff8d46c
NDC45865-374
Product TypeHuman Prescription Drug
Proprietary NameNizatidine
Generic NameNizatidine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA090618
Labeler NameMedsource Pharmaceuticals
Substance NameNIZATIDINE
Active Ingredient Strength150 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45865-374-60

60 CAPSULE in 1 BOTTLE (45865-374-60)
Marketing Start Date2011-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-374-60 [45865037460]

Nizatidine CAPSULE
Marketing CategoryANDA
Application NumberANDA090618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NIZATIDINE150 mg/1

OpenFDA Data

SPL SET ID:1d6161e3-2ddb-5446-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312025
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Nizatidine" or generic name "Nizatidine"

    NDCBrand NameGeneric Name
    0185-0150nizatidinenizatidine
    0185-0300nizatidinenizatidine
    0378-5150Nizatidinenizatidine
    0378-5300Nizatidinenizatidine
    0591-3137NizatidineNizatidine
    0591-3138NizatidineNizatidine
    21695-043NizatidineNizatidine
    21695-375nizatidinenizatidine
    42254-093NizatidineNizatidine
    45865-374NizatidineNizatidine
    52959-824NizatidineNizatidine
    55111-310NizatidineNizatidine
    55111-311NizatidineNizatidine
    60846-301NIZATIDINENIZATIDINE
    63187-249NizatidineNizatidine
    63629-2769NizatidineNizatidine
    65162-659NizatidineNizatidine
    68071-1633NizatidineNizatidine
    68071-5043NizatidineNizatidine
    68151-0017NizatidineNizatidine
    68258-3006NizatidineNizatidine
    68462-425NizatidineNizatidine
    68462-426NizatidineNizatidine
    68788-8913NizatidineNizatidine
    71335-0086NizatidineNizatidine

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