NDC 67546-212

Alinia

Nitazoxanide

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

• Product ID: 67546-212_7a8d52fc-09ba-c364-e053-2991aa0ab2e4
• NDC: 67546-212
• Product Type: Human Prescription Drug
• Proprietary Name: Alinia
• Generic Name: Nitazoxanide
• Dosage Form: Powder, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2002-11-22
• Marketing Category: NDA / NDA
• Application Number: NDA021498
• Labeler Name: Romark Laboratories, L.C.
• Substance Name: NITAZOXANIDE
• Active Ingredient Strength: 100 mg/5mL
• Pharm Classes: Antiprotozoal [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67546-212-21

1 BOTTLE, GLASS in 1 CARTON (67546-212-21) > 60 mL in 1 BOTTLE, GLASS

• Marketing Start Date: 2002-11-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67546-212-21 [67546021221]

Alinia POWDER, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA021498
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2002-11-22

Drug Details

Active Ingredients

Ingredient	Strength
NITAZOXANIDE	100 mg/5mL

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

67546021221 ALINIA 100 MG/5 ML SUSPENSION

Pricing Unit: ML | 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