NDC 71335-0086

Nizatidine

Nizatidine

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

Product ID71335-0086_1177e261-a933-4375-8708-c865094f3fb6
NDC71335-0086
Product TypeHuman Prescription Drug
Proprietary NameNizatidine
Generic NameNizatidine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2011-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA090618
Labeler NameBryant Ranch Prepack
Substance NameNIZATIDINE
Active Ingredient Strength150 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 71335-0086-1

60 CAPSULE in 1 BOTTLE (71335-0086-1)
Marketing Start Date2012-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0086-3 [71335008603]

Nizatidine CAPSULE
Marketing CategoryANDA
Application NumberANDA090618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-12
Inactivation Date2020-01-31

NDC 71335-0086-4 [71335008604]

Nizatidine CAPSULE
Marketing CategoryANDA
Application NumberANDA090618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-12
Inactivation Date2020-01-31

NDC 71335-0086-2 [71335008602]

Nizatidine CAPSULE
Marketing CategoryANDA
Application NumberANDA090618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-12
Inactivation Date2020-01-31

NDC 71335-0086-1 [71335008601]

Nizatidine CAPSULE
Marketing CategoryANDA
Application NumberANDA090618
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-12
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
NIZATIDINE150 mg/1

OpenFDA Data

SPL SET ID:b721d5ee-c6e6-4416-a996-b404cc993167
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.