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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218701-001NITAZOXANIDENITAZOXANIDE500MGTABLET / ORALAB2025-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218701-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218701-001NITAZOXANIDE500MGTABLET / ORALAB2025-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218701-001NITAZOXANIDE500MGTABLET / ORALAB2025-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A218701-001NITAZOXANIDE500MGTABLET / ORALAB2025-04-156a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218701-001NITAZOXANIDE500MGTABLET / ORALAB2025-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218701-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218701-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218701-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218701-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOA12P041NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
427163Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
295011e1-f919-4e5a-b9e7-4c784f623a86Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitazoxanideNITAZOXANIDECamber Pharmaceuticals, Inc.295011e1-f919-4e5a-b9e7-4c784f623a862025-12-30Adverse reactionsExact identifier
application applno (ANDA): 218701
application number: ANDA218701
ndc (product): 31722-100

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