NDC 67546-111

Alinia

Nitazoxanide

Alinia is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Romark Laboratories, L.c.. The primary component is Nitazoxanide.

Product ID67546-111_7a8d52fc-09ba-c364-e053-2991aa0ab2e4
NDC67546-111
Product TypeHuman Prescription Drug
Proprietary NameAlinia
Generic NameNitazoxanide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-07-21
Marketing CategoryNDA / NDA
Application NumberNDA021497
Labeler NameRomark Laboratories, L.C.
Substance NameNITAZOXANIDE
Active Ingredient Strength500 mg/1
Pharm ClassesAntiprotozoal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67546-111-12

1 BOTTLE, PLASTIC in 1 CARTON (67546-111-12) > 30 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date2004-07-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67546-111-37 [67546011137]

Alinia TABLET
Marketing CategoryNDA
Application NumberNDA021497
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-07-21
Marketing End Date2012-06-02

NDC 67546-111-17 [67546011117]

Alinia TABLET
Marketing CategoryNDA
Application NumberNDA021497
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-25
Marketing End Date2016-02-18

NDC 67546-111-14 [67546011114]

Alinia TABLET
Marketing CategoryNDA
Application NumberNDA021497
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-07-21

NDC 67546-111-11 [67546011111]

Alinia TABLET
Marketing CategoryNDA
Application NumberNDA021497
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-07-21
Marketing End Date2013-11-25

NDC 67546-111-12 [67546011112]

Alinia TABLET
Marketing CategoryNDA
Application NumberNDA021497
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-07-21

Drug Details

Active Ingredients

IngredientStrength
NITAZOXANIDE500 mg/1

OpenFDA Data

SPL SET ID:56b1575a-dff4-4c5a-a159-2f858e7a0cb8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 404419
  • 359822
  • 540617
  • 427163
  • UPC Code
  • 0367546212213
  • 0367546111172
  • Pharmacological Class

    • Antiprotozoal [EPC]

    Medicade Reported Pricing

    67546011114 ALINIA 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    67546011112 ALINIA 500 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Alinia" or generic name "Nitazoxanide"

    NDCBrand NameGeneric Name
    67546-111Alinianitazoxanide
    67546-212Alinianitazoxanide
    43386-405N/Anitazoxanide
    64980-526NitazoxanideNitazoxanide

    Trademark Results [Alinia]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ALINIA
    ALINIA
    98653328 not registered Live/Pending
    Alinia AI, Inc.
    2024-07-17
    ALINIA
    ALINIA
    78188660 2812956 Live/Registered
    ROMARK LABORATORIES, L.C.
    2002-11-25

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