Application 078680

Type: ANDA
Sponsor: UNICHEM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

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
A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-06-26
A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-06-26
A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2009-06-26
A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2009-06-26

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	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078680-001	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2009-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078680-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2009-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078680-003	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2009-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078680-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2009-06-26	`5bbf6a4d5a75…`

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 11 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	adcd0e8e-cca7-e1bb-e053-2995a90a83be	2023-05-17	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
betr remedies all day allergy relief	CETIRIZINE HYDROCHLORIDE	Live Betr LLC	4a017852-db01-4085-8947-d92a19ec4e5c	2023-05-10	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Crcle Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Innovus Pharmaceuticals, Inc.	640583b6-379d-4ad3-b00c-383377c54eed	2023-04-21	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f5920-d82f-6549-e053-2995a90ad58a	2023-04-11	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Navajo Manufacturing Company Incorporated	9c4693cb-f066-0666-e053-2a95a90a96d3	2023-03-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
topcare all day allergy	CETIRIZINE HYDROCHLORIDE	Topco Associates LLC	10c512a1-bb96-4d2a-9e41-a422efb57e28	2023-02-09	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
careone allergy relief	CETIRIZINE HYDROCHLORIDE	Retail Business Services, LLC	6d94d302-b79a-4143-bb3c-c74da2a6a72e	2022-10-20	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Welby Childrens Allergy Relief	CETIRIZINE HYDROCHLORIDE	Aldi Inc	a8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a	2022-10-13	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Allergy Relief	CETIRIZINE HYDROCHLORIDE	MARC GLASSMAN, INC.	951b6f19-15fe-45d7-e053-2995a90aa254	2022-10-06	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free Grape	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	582db483-394e-4c00-8522-4041a11696e4	2022-10-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Good Sense All Day Allergy	CETIRIZINE HYDROCHLORIDE	L. Perrigo Company	5b1203c7-9678-4cee-9d7b-6510da295561	2022-09-08	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	1bbefda2-d3c5-4d31-b3ec-7da077e41157	2022-08-16	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Strategic Sourcing Services	1dd63ede-37ca-4b5a-bfed-1aca5dd15424	2022-07-27	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	RITE AID CORPORATION	de169567-5cde-5c4a-e053-2a95a90a1215	2022-07-21	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	d14feb90-3ca2-4d5b-825c-25fc2252ca38	2022-06-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC.	dfbddafb-9455-5805-e053-2a95a90ad0d9	2022-05-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	198ca875-bb8a-49d5-8809-7121ba119381	2022-04-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp Inc	6baa66e7-93df-43d9-a301-5d9c14274c99	2022-04-01	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
allergy relief	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	268170c9-b6a7-4851-b7d3-33dd1d733e39	2022-03-07	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	487ae0f0-320c-4534-b9e2-0e215f167cea	2022-01-12	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-133	cetirizine hydrochloride	cetirizine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-134	cetirizine hydrochloride	cetirizine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-330	cetirizine hydrochloride	cetirizine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-340	cetirizine hydrochloride	cetirizine hydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current