Cetirizine Hydrochloride

Product NDC: 49483-682
11-digit product format: 494830682
Labeler code: 49483
Product ID: 49483-682_dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC.
Application: ANDA078933
Marketing category: ANDA
Marketing start: 2022-05-30
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-06-15
A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-15
A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2010-06-15
A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2010-06-15

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078933-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2010-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078933-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2010-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078933-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2010-06-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078933-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2010-06-15	`d06236e962d9…`

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014676	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
dfbddafb-9455-5805-e053-2a95a90ad0d9	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	Strength	SPL version
49483-682-01	Cetirizine Hydrochloride	100 in 1 BOTTLE	TABLET	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-682-01	EA - Each	49483-682	e4f5cd42-9b7e-4034-99cf-2c70b1195b3d	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-682	CETIRIZINE HYDROCHLORIDE TABLET [TIME CAP LABORATORIES, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20220530_dfbddafb-9455-5805-e053-2a95a90ad0d9.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)	CETIRIZINE HYDROCHLORIDE	MARKSANS PHARMA LIMITED	652b0c65-a3f2-4454-9cf2-51a3389282cc	2026-07-10	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Cetirizine Hydrochloride Tablets,10 mg	CETIRIZINE HYDROCHLORIDE	Northwind Health Company, LLC	f756d3b1-d2e4-3705-e053-6294a90aa380	2026-01-01	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
ALLERGY	CETIRIZINE HYDROCHLORIDE	Kroger Company	bc020340-ef39-e49a-e053-2a95a90af810	2025-09-11	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Allergy Relief	CETIRIZINE HYDROCHLORIDE	BETTER LIVING BRANDS, LLC	eb60ae7d-87db-7413-e053-2a95a90afd76	2025-06-28	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Cetirizine Hydrochloride Tablets,10 mg	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	d78223ba-80d5-47f8-e053-2a95a90aebdb	2024-03-06	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	DOLGENCORP, INC.	0643ea78-9709-8526-e063-6394a90a227b	2023-12-15	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Allergy Relief	CETIRIZINE HYDROCHLORIDE	WALGREENS	f3c66f47-016a-799a-e053-2995a90ad424	2023-10-21	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	dfbddafb-9455-5805-e053-2a95a90ad0d9	2022-05-24	Warnings	Exact identifier application applno (ANDA): 078933 application number: ANDA078933 ndc (product): 49483-682

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
1014676	cetirizine HCl 5 MG Oral Tablet	PSN	dfbddafb-9455-5805-e053-2a95a90ad0d9	1
1014676	cetirizine hydrochloride 5 MG Oral Tablet	SCD	dfbddafb-9455-5805-e053-2a95a90ad0d9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-682-01	49483068201	100 TABLET in 1 BOTTLE (49483-682-01)	100 tablet	2022-05-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
682R Timely 49483-682 Cetirizine hydrochloride tablets USP 5 mg	TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2022-05-24	HUMAN OTC DRUG LABEL	1