N/A (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

Nitazoxanide Tablets are round, yellow, film-coated tablets debossed with 77 on one side and plain on the other side. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles of 12 and 30 tablets.

Bottles of 12 tablets NDC 43386-405-12

Bottles of 30 tablets NDC 43386-405-03

Store the tablets at 25 ^o C (77 ^o F); excursions permitted to 15 ^o C-30 ^o C (59 ^o F-86 ^o F). [See USP Controlled Room Temperature]

17 PATIENT COUNSELING INFORMATION

Advise patients and parents/caregivers of pediatric patients taking Nitazoxanide Tablets of the following information:

Dosage and Administration:

Nitazoxanide Tablets should be taken with food.

Drug-drug Interactions:

Avoid concurrent warfarin use.

MANUFACTURER INFORMATION

Manufactured By:

Romark Laboratorties, L.C.

Tampa, FL 33607
Telephone: 813-282-8544, Fax: 813-282-1162
E-mail: customer.service@romark.com
Website: www.romark.com

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202

SAP code: 266925 Iss.: 12/2021

Nitazoxanide Tablets — 30 ct Label

NDC 43386-405-03

Nitazoxanide Tablets

500 mg

Rx Only

LUPIN 30 TABLETS

Nitazoxanide Tablets — 30 ct Carton

NDC 43386-405-03

Nitazoxanide Tablets

500 mg

Rx Only

LUPIN 30 Tablets

Nitazoxanide Tablets — 12 ct Label

NDC 43386-405-12

Nitazoxanide Tablets

500 mg

Rx only

LUPIN 12 Tablets

NitazoxanideTablets — 12 ct Carton

NDC 43386-405-12

Nitazoxanide Tablets

500 mg

Rx only

LUPIN 12 Tablets

N/A nitazoxanide tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-405 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITAZOXANIDE (NITAZOXANIDE) NITAZOXANIDE 500 mg

Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE D&C YELLOW NO. 10 FD&C YELLOW NO. 6 FD&C BLUE NO. 2 STARCH, CORN HYPROMELLOSES SUCROSE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC MAGNESIUM STEARATE LECITHIN, SOYBEAN POLYVINYL ALCOHOL XANTHAN GUM

Product Characteristics Color yellow (yellow) Score no score Shape ROUND (ROUND) Size 13mm Flavor Imprint Code 77 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43386-405-03 30 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 30 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (43386-405-03) 2 NDC:43386-405-12 12 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 2 12 TABLET in 1 BOTTLE, PLASTIC This package is contained within the CARTON (43386-405-12)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA021497 02/17/2021

Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Registrant — Romark Laboratories, L.C. (877685123)

Establishment
Name	Address	ID/FEI	Operations
Catalent Pharma Solutions, LLC		014167995	analysis (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Neolpharma, Inc.		078709787	manufacture (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Romark Global Pharma, LLC		080015267	analysis (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Romark Global Pharma, LLC		117034720	manufacture (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Aphena Pharma Solutions — Tennessee, LLC		128385585	pack (43386-405), label (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Whitehouse Analytical Laboratories, LLC		138628008	analysis (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Patheon Puerto Rico, Inc.		143814544	analysis (43386-405)

Establishment
Name	Address	ID/FEI	Operations
PACE Analytical Inc.		362250102	analysis (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Romark Belgium, BVBA		370420271	api manufacture (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Catalent Pharma Solutions, LLC		825745131	manufacture (43386-405)

Establishment
Name	Address	ID/FEI	Operations
Catalent Pharma Solutions, LLC		829672745	manufacture (43386-405)

Revised: 01/2022 Lupin Pharmaceuticals, Inc.