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 ID: 67546-111_7a8d52fc-09ba-c364-e053-2991aa0ab2e4
• NDC: 67546-111
• Product Type: Human Prescription Drug
• Proprietary Name: Alinia
• Generic Name: Nitazoxanide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2004-07-21
• Marketing Category: NDA / NDA
• Application Number: NDA021497
• Labeler Name: Romark Laboratories, L.C.
• Substance Name: NITAZOXANIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Antiprotozoal [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67546-111-12

1 BOTTLE, PLASTIC in 1 CARTON (67546-111-12) > 30 TABLET in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2004-07-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67546-111-37 [67546011137]

Alinia TABLET

• Marketing Category: NDA
• Application Number: NDA021497
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-07-21
• Marketing End Date: 2012-06-02

NDC 67546-111-17 [67546011117]

Alinia TABLET

• Marketing Category: NDA
• Application Number: NDA021497
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-11-25
• Marketing End Date: 2016-02-18

NDC 67546-111-14 [67546011114]

Alinia TABLET

• Marketing Category: NDA
• Application Number: NDA021497
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-07-21

NDC 67546-111-11 [67546011111]

Alinia TABLET

• Marketing Category: NDA
• Application Number: NDA021497
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-07-21
• Marketing End Date: 2013-11-25

NDC 67546-111-12 [67546011112]

Alinia TABLET

• Marketing Category: NDA
• Application Number: NDA021497
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-07-21

Drug Details

Active Ingredients

Ingredient	Strength
NITAZOXANIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 56b1575a-dff4-4c5a-a159-2f858e7a0cb8
• Manufacturer:
  • Romark Laboratories, L.C.
• UNII:
  • SOA12P041N
• 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"

NDC	Brand Name	Generic Name
67546-111	Alinia	nitazoxanide
67546-212	Alinia	nitazoxanide
43386-405	N/A	nitazoxanide
64980-526	Nitazoxanide	Nitazoxanide