FDA.reportPublic FDA data

Cetirizine hydrochloride

Product NDC
72888-480
11-digit product format
728880480
Labeler code
72888
Product ID
72888-480_4c56197b-744a-fe94-e063-6394a90ac0e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Advagen Pharma Ltd.,
Application
ANDA220335
Marketing category
ANDA
Marketing start
2026-02-25
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A220335-001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2026-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220335-001AA

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
2026-09-14 22:38:342026-08A220335-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2026-02-2584e616aacf4f…
2026-08-18 06:07:402026-07A220335-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2026-02-25caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220335-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2026-02-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220335-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A220335-001AA1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220335-001AA1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014673Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0956baea-f0ad-4aac-9464-831840db9230Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-480-01Cetirizine hydrochloride120 mL in 1 BOTTLESOLUTION1201

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
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvagen Pharma Ltd.,0956baea-f0ad-4aac-9464-831840db92302026-03-06Adverse reactionsExact identifier
application applno (ANDA): 220335
application number: ANDA220335
ndc (product): 72888-480

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN0956baea-f0ad-4aac-9464-831840db92301
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD0956baea-f0ad-4aac-9464-831840db92301
1014673cetirizine HCl 1 MG/ML Oral SyrupSY0956baea-f0ad-4aac-9464-831840db92301
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY0956baea-f0ad-4aac-9464-831840db92301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-480-0172888048001120 mL in 1 BOTTLE (72888-480-01) 120 ml2026-02-25NoNoCurrent