Cetirizine HCl

Product NDC: 72657-128
Requested package NDC: 72657-128-14
11-digit product format: 726570128
Labeler code: 72657
Product ID: 72657-128_42c1f2da-97b4-4583-bf62-368be53900c2
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: 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL			2007-12-28
A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL			2007-12-28

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078427-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078427-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-28	`74a2ff9319b5…`

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 HCl
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
64O047KTOA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
04b08c52-5390-4cdb-a9e7-fca81fffdc73	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72657-128-03	Cetirizine HCl	300 in 1 BOTTLE	TABLET	300	5
72657-128-03	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-04	Cetirizine HCl	400 in 1 BOTTLE	TABLET	400	5
72657-128-04	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-08	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-08	Cetirizine HCl	120 in 1 BOTTLE	TABLET	120	5
72657-128-14	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-14	Cetirizine HCl	140 in 1 BOTTLE	TABLET	140	5
72657-128-15	Cetirizine HCl	150 in 1 BOTTLE	TABLET	150	5
72657-128-15	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-18	Cetirizine HCl	180 in 1 BOTTLE	TABLET	180	5
72657-128-18	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-24	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-24	Cetirizine HCl	240 in 1 BOTTLE	TABLET	240	5
72657-128-30	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-30	Cetirizine HCl	30 in 1 BOTTLE	TABLET	30	5
72657-128-35	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-35	Cetirizine HCl	365 in 1 BOTTLE	TABLET	365	5
72657-128-41	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-41	Cetirizine HCl	14 in 1 BOTTLE	TABLET	14	5
72657-128-45	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-45	Cetirizine HCl	45 in 1 BOTTLE	TABLET	45	5
72657-128-60	Cetirizine HCl	60 in 1 BOTTLE	TABLET	60	5
72657-128-60	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-70	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5
72657-128-70	Cetirizine HCl	70 in 1 BOTTLE	TABLET	70	5
72657-128-81	Cetirizine HCl	60 in 1 BOTTLE	TABLET	60	5
72657-128-81	Cetirizine HCl	2 in 1 CARTON	TABLET	2	5
72657-128-82	Cetirizine HCl	70 in 1 BOTTLE	TABLET	70	5
72657-128-82	Cetirizine HCl	2 in 1 CARTON	TABLET	2	5
72657-128-84	Cetirizine HCl	90 in 1 BOTTLE	TABLET	90	5
72657-128-84	Cetirizine HCl	2 in 1 CARTON	TABLET	2	5
72657-128-86	Cetirizine HCl	120 in 1 BOTTLE	TABLET	120	5
72657-128-86	Cetirizine HCl	2 in 1 CARTON	TABLET	2	5
72657-128-90	Cetirizine HCl	90 in 1 BOTTLE	TABLET	90	5
72657-128-90	Cetirizine HCl	1 in 1 CARTON	TABLET	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72657-128	CETIRIZINE HCL (CETIRIZINE) TABLET CETIRIZINE HCL (CETIRIZINE) KIT [GLENMARK THERAPEUTICS INC., USA]	5	Current NDC, 36 package rows	20250423_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine HCl	CETIRIZINE	GLENMARK THERAPEUTICS INC., USA	04b08c52-5390-4cdb-a9e7-fca81fffdc73	2026-08-07	Warnings	Exact identifier application applno (ANDA): 078427 application number: ANDA078427 ndc (package): 72657-128-14 ndc (product): 72657-128 ndc11 (package): 72657012814
Cetirizine HCl	CETIRIZINE	Strategic Sourcing Services LLC	65b37b00-8efc-4e04-ab97-a03e8af27d33	2025-04-04	Warnings	Exact identifier application applno (ANDA): 078427 application number: ANDA078427

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE
YO7261ME24	CETIRIZINE	83881-51-0	Cetirizine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	04b08c52-5390-4cdb-a9e7-fca81fffdc73	5
1014676	cetirizine HCl 5 MG Oral Tablet	PSN	04b08c52-5390-4cdb-a9e7-fca81fffdc73	5
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	04b08c52-5390-4cdb-a9e7-fca81fffdc73	5
1014676	cetirizine hydrochloride 5 MG Oral Tablet	SCD	04b08c52-5390-4cdb-a9e7-fca81fffdc73	5
1014678	cetirizine HCl 10 MG Oral Tablet	SY	04b08c52-5390-4cdb-a9e7-fca81fffdc73	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72657-128-14	72657012814	1 BOTTLE in 1 CARTON (72657-128-14) / 140 TABLET in 1 BOTTLE	1 bottle	2024-05-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	GLENMARK THERAPEUTICS INC., USA \| Glenmark Pharmaceuticals Limited	2026-08-07	HUMAN OTC DRUG LABEL	7