FDA.reportPublic FDA data

Nitazoxanide

Product NDC
31722-100
11-digit product format
317220100
Labeler code
31722
Product ID
31722-100_4729e7ee-3333-ee2b-e063-6394a90aa85c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitazoxanide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218701
Marketing category
ANDA
Marketing start
2025-04-15
Substance
NITAZOXANIDE
Active strength
500 mg/1
Pharmacologic classes
Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nitazoxanide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITAZOXANIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOA12P041N
Rxcui427163

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cec5eadb-226e-482c-b9e2-1bc9a6b1427eProduct name220251118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-100-30Nitazoxanide1 in 1 CARTONTABLET, FILM COATED11
31722-100-30Nitazoxanide30 in 1 BOTTLETABLET, FILM COATED301
31722-100-31Nitazoxanide1 in 1 CARTONTABLET, FILM COATED11
31722-100-31Nitazoxanide12 in 1 BOTTLETABLET, FILM COATED121
31722-100-32Nitazoxanide1 in 1 CARTONTABLET, FILM COATED11
31722-100-32Nitazoxanide6 in 1 BOTTLETABLET, FILM COATED61

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
427163nitazoxanide 500 MG Oral TabletPSN295011e1-f919-4e5a-b9e7-4c784f623a861
427163nitazoxanide 500 MG Oral TabletSCD295011e1-f919-4e5a-b9e7-4c784f623a861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-100-30317220100301 BOTTLE in 1 CARTON (31722-100-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-15NoNoCurrent
31722-100-31317220100311 BOTTLE in 1 CARTON (31722-100-31) / 12 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-15NoNoCurrent
31722-100-32317220100321 BOTTLE in 1 CARTON (31722-100-32) / 6 TABLET, FILM COATED in 1 BOTTLE1 bottle2025-04-15NoNoCurrent