Cetirizine Hydrochloride

Product NDC: 53943-519
11-digit product format: 539430519
Labeler code: 53943
Product ID: 53943-519_5c71a4a6-cf88-4fdc-db4f-23235af0306b
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Discount Drug Mart, Inc
Application: ANDA078343
Marketing category: ANDA
Marketing start: 2020-01-20
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2008-01-15
A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-01-15
A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2008-01-15
A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2008-01-15

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078343-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2008-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078343-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2008-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078343-003	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2008-01-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078343-004	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2008-01-15	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
c7c7e496-3682-c764-88ef-d2a09823f71e	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
53943-519-30	Cetirizine Hydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	4
53943-519-30	Cetirizine Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
53943-519-45	Cetirizine Hydrochloride	45 in 1 BOTTLE	TABLET, FILM COATED	45	4
53943-519-45	Cetirizine Hydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-519	CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DISCOUNT DRUG MART, INC]	3	Current NDC, Legacy NDC, 4 package rows	20231009_c7c7e496-3682-c764-88ef-d2a09823f71e.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Preferred Pharmaceuticals Inc.	14a885e5-5e75-4a18-b5bc-6aaa748712db	2026-03-25	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Proficient Rx LP	55b1738c-fa72-4cd1-a8e8-be41b12b593d	2026-03-01	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Sportpharm LLC	d5297bdb-823c-4318-a797-5311d5cf0df8	2026-02-06	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Northwind Health Company, LLC	f70886af-a8a4-63a0-e053-6294a90a2d2c	2026-01-01	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	VERITYRX, LLC	42778a1c-6894-8646-e063-6294a90a6cb5	2025-10-31	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Bryant Ranch Prepack	e4324124-13f8-4450-9fd6-686bd6e25578	2025-10-28	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Dr. Reddy's Laboratories Inc.	206ab55a-3720-6205-d710-6e7953571418	2025-07-17	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Strategic Sourcing Services LLC	52b70885-f623-b1c8-29c6-584bff46ed45	2025-07-17	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Discount Drug Mart, Inc	c7c7e496-3682-c764-88ef-d2a09823f71e	2025-07-16	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343 ndc (product): 53943-519
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE TABLETS	Dr. Reddy's Laboratories Inc.	e4eca4df-9ad8-b7c4-b512-bfaed5673789	2025-07-16	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Dr.Reddy's Laboratories Limited	de152651-bfcd-856a-8329-a2ac93a376bc	2011-09-30	Warnings	Exact identifier application applno (ANDA): 078343 application number: ANDA078343

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	c7c7e496-3682-c764-88ef-d2a09823f71e	4
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	c7c7e496-3682-c764-88ef-d2a09823f71e	4
1014678	cetirizine HCl 10 MG Oral Tablet	SY	c7c7e496-3682-c764-88ef-d2a09823f71e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-519-30	53943051930	1 BOTTLE in 1 CARTON (53943-519-30) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-01-20	0000-00-00	No	No	Current
53943-519-45	53943051945	1 BOTTLE in 1 CARTON (53943-519-45) / 45 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-01-20	0000-00-00	No	No	Current