NDC 0378-5150

Nizatidine

Nizatidine

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

Product ID0378-5150_1510df83-b013-4280-b49b-d0d2a23e86d4
NDC0378-5150
Product TypeHuman Prescription Drug
Proprietary NameNizatidine
Generic NameNizatidine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2002-07-10
Marketing End Date2020-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA075806
Labeler NameMylan Pharmaceuticals Inc.
Substance NameNIZATIDINE
Active Ingredient Strength150 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN

Packaging

NDC 0378-5150-91

60 CAPSULE in 1 BOTTLE, PLASTIC (0378-5150-91)
Marketing Start Date2002-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-5150-05 [00378515005]

Nizatidine CAPSULE
Marketing CategoryANDA
Application NumberANDA075806
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-07-10
Marketing End Date2014-02-28

NDC 0378-5150-91 [00378515091]

Nizatidine CAPSULE
Marketing CategoryANDA
Application NumberANDA075806
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-07-10
Marketing End Date2020-05-31

NDC 0378-5150-01 [00378515001]

Nizatidine CAPSULE
Marketing CategoryANDA
Application NumberANDA075806
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-07-10
Marketing End Date2014-02-28

Drug Details

Active Ingredients

IngredientStrength
NIZATIDINE150 mg/1

OpenFDA Data

SPL SET ID:db844934-9c1d-4576-a1b5-ef9b9c66a940
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198041
  • 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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