FDA.reportPublic FDA data

Cetirizine HCl

Product NDC
72657-128
11-digit product format
726570128
Labeler code
72657
Product ID
72657-128_9b19f466-3796-44b8-a637-092926c275f1
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine
Dosage form
TABLET
Route
ORAL
Labeler
GLENMARK THERAPEUTICS INC., USA
Application
ANDA078427
Marketing category
ANDA
Marketing start
2024-05-13
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078427-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-28
A078427-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-28

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078427-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A078427-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-28782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014676Internal RxNorm lookup
1014678Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04b08c52-5390-4cdb-a9e7-fca81fffdc73Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72657-128-03Cetirizine HCl300 in 1 BOTTLETABLET3005
72657-128-03Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-04Cetirizine HCl400 in 1 BOTTLETABLET4005
72657-128-04Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-08Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-08Cetirizine HCl120 in 1 BOTTLETABLET1205
72657-128-14Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-14Cetirizine HCl140 in 1 BOTTLETABLET1405
72657-128-15Cetirizine HCl150 in 1 BOTTLETABLET1505
72657-128-15Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-18Cetirizine HCl180 in 1 BOTTLETABLET1805
72657-128-18Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-24Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-24Cetirizine HCl240 in 1 BOTTLETABLET2405
72657-128-30Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-30Cetirizine HCl30 in 1 BOTTLETABLET305
72657-128-35Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-35Cetirizine HCl365 in 1 BOTTLETABLET3655
72657-128-41Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-41Cetirizine HCl14 in 1 BOTTLETABLET145
72657-128-45Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-45Cetirizine HCl45 in 1 BOTTLETABLET455
72657-128-60Cetirizine HCl60 in 1 BOTTLETABLET605
72657-128-60Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-70Cetirizine HCl1 in 1 CARTONTABLET15
72657-128-70Cetirizine HCl70 in 1 BOTTLETABLET705
72657-128-81Cetirizine HCl60 in 1 BOTTLETABLET605
72657-128-81Cetirizine HCl2 in 1 CARTONTABLET25
72657-128-82Cetirizine HCl70 in 1 BOTTLETABLET705
72657-128-82Cetirizine HCl2 in 1 CARTONTABLET25
72657-128-84Cetirizine HCl90 in 1 BOTTLETABLET905
72657-128-84Cetirizine HCl2 in 1 CARTONTABLET25
72657-128-86Cetirizine HCl120 in 1 BOTTLETABLET1205
72657-128-86Cetirizine HCl2 in 1 CARTONTABLET25
72657-128-90Cetirizine HCl90 in 1 BOTTLETABLET905
72657-128-90Cetirizine HCl1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72657-128CETIRIZINE HCL (CETIRIZINE) TABLET CETIRIZINE HCL (CETIRIZINE) KIT [GLENMARK THERAPEUTICS INC., USA]5Current NDC, 36 package rows20250423_04b08c52-5390-4cdb-a9e7-fca81fffdc73.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HClCETIRIZINEGLENMARK THERAPEUTICS INC., USA04b08c52-5390-4cdb-a9e7-fca81fffdc732026-02-06WarningsExact identifier
application applno (ANDA): 078427
application number: ANDA078427
ndc (product): 72657-128
Cetirizine HClCETIRIZINEStrategic Sourcing Services LLC65b37b00-8efc-4e04-ab97-a03e8af27d332025-04-04WarningsExact identifier
application applno (ANDA): 078427
application number: ANDA078427

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN04b08c52-5390-4cdb-a9e7-fca81fffdc735
1014676cetirizine HCl 5 MG Oral TabletPSN04b08c52-5390-4cdb-a9e7-fca81fffdc735
1014678cetirizine hydrochloride 10 MG Oral TabletSCD04b08c52-5390-4cdb-a9e7-fca81fffdc735
1014676cetirizine hydrochloride 5 MG Oral TabletSCD04b08c52-5390-4cdb-a9e7-fca81fffdc735
1014678cetirizine HCl 10 MG Oral TabletSY04b08c52-5390-4cdb-a9e7-fca81fffdc735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72657-128-03726570128031 BOTTLE in 1 CARTON (72657-128-03) / 300 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-04726570128041 BOTTLE in 1 CARTON (72657-128-04) / 400 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-08726570128081 BOTTLE in 1 CARTON (72657-128-08) / 120 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-14726570128141 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-15726570128151 BOTTLE in 1 CARTON (72657-128-15) / 150 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-18726570128181 BOTTLE in 1 CARTON (72657-128-18) / 180 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-24726570128241 BOTTLE in 1 CARTON (72657-128-24) / 240 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-30726570128301 BOTTLE in 1 CARTON (72657-128-30) / 30 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-35726570128351 BOTTLE in 1 CARTON (72657-128-35) / 365 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-41726570128411 BOTTLE in 1 CARTON (72657-128-41) / 14 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-45726570128451 BOTTLE in 1 CARTON (72657-128-45) / 45 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-60726570128601 BOTTLE in 1 CARTON (72657-128-60) / 60 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-70726570128701 BOTTLE in 1 CARTON (72657-128-70) / 70 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent
72657-128-81726570128812 BOTTLE in 1 CARTON (72657-128-81) / 60 TABLET in 1 BOTTLE2 bottle2024-05-13NoNoCurrent
72657-128-82726570128822 BOTTLE in 1 CARTON (72657-128-82) / 70 TABLET in 1 BOTTLE2 bottle2024-05-13NoNoCurrent
72657-128-84726570128842 BOTTLE in 1 CARTON (72657-128-84) / 90 TABLET in 1 BOTTLE2 bottle2024-05-13NoNoCurrent
72657-128-86726570128862 BOTTLE in 1 CARTON (72657-128-86) / 120 TABLET in 1 BOTTLE2 bottle2024-05-13NoNoCurrent
72657-128-90726570128901 BOTTLE in 1 CARTON (72657-128-90) / 90 TABLET in 1 BOTTLE1 bottle2024-05-13NoNoCurrent