CETIRIZINE HYDROCHLORIDE

Product NDC: 69452-465
Requested package NDC: 69452-465-81
11-digit product format: 694520465
Labeler code: 69452
Product ID: 69452-465_45745bf3-a132-b51a-e063-6394a90a712e
Type: HUMAN OTC DRUG
Nonproprietary name: CETIRIZINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA078862
Marketing category: ANDA
Marketing start: 2024-10-20
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 43.

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
A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-02-19
A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-02-19
A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-02-19
A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-02-19

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 · 172 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	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078862-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078862-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078862-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078862-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-02-19	`5bbf6a4d5a75…`

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: 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
831d4141-b3be-4d98-a372-9c4d57ad296c	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
69452-465-81	CETIRIZINE HYDROCHLORIDE	400 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	400		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-465	CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [BIONPHARMA INC.]	1	Current NDC, 1 package rows	20241021_831d4141-b3be-4d98-a372-9c4d57ad296c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE TABLETS	DISCOUNT DRUG MART, INC	4b9576dc-d7f9-dc10-e063-6294a90a233e	2026-04-23	Warnings	Exact identifier application applno (ANDA): 078862 application number: ANDA078862
Hives Relief	CETIRIZINE TABLETS	WALGREEN COMPANY	4526b65c-b0e7-180c-e063-6394a90ae916	2026-03-16	Warnings	Exact identifier application applno (ANDA): 078862 application number: ANDA078862
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	Bionpharma Inc.	831d4141-b3be-4d98-a372-9c4d57ad296c	2025-12-08	Warnings	Exact identifier application applno (ANDA): 078862 application number: ANDA078862 ndc (package): 69452-465-81 ndc (product): 69452-465 ndc11 (package): 69452046581

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	831d4141-b3be-4d98-a372-9c4d57ad296c	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	831d4141-b3be-4d98-a372-9c4d57ad296c	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	831d4141-b3be-4d98-a372-9c4d57ad296c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69452-465-81	69452046581	400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81)	2024-10-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
STARCH, CORN - Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2025-12-08	HUMAN OTC DRUG LABEL	2