Application 213105

Type: ANDA
Sponsor: CATALENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	CAPSULE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2020-09-21

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.

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	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213105-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2020-09-21	`a50c72e98297…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HCL	WALMART INC. (see also Equate)	967be504-85b1-4e9b-9b08-2b27a43fa0aa	2026-06-18	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
Allergy Relief	CETIRIZINE HCL	CVS PHARMACY, INC	fb850a4c-7ac1-4993-b6ea-5c8d42e17703	2026-05-18	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
All Day Allergy	CETIRIZINE HCL	WALMART INC. (see also Equate)	c8016d34-aa72-4857-b5ed-5476948b386a	2026-02-20	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 79903-084
Allergy Relief	CETIRIZINE HCL	Safeway, Inc.	1fbb274c-cacc-4ba9-be97-33d83e2773db	2025-12-16	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 21130-364
ZYRTEC Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	0face45c-af24-3559-e063-6294a90abde5	2025-10-21	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105
All Day Allergy Relief	CETIRIZINE HCL	P & L Development, LLC	7dabf6bd-8a96-4e7f-bc19-5a47cec36419	2025-05-16	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 59726-064
basic care all day allergy	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	e71e259a-494e-4a9a-b0e4-25bd25dd0e07	2025-04-06	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 72288-980
Allergy Relief	CETIRIZINE HCL	H E B	4bbf0be5-7bcc-46c6-a443-7b37d4679c6f	2024-05-10	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 37808-564
topcare all day allergy	CETIRIZINE HYDROCHLORIDE	Topco Associates LLC	10c512a1-bb96-4d2a-9e41-a422efb57e28	2023-02-09	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 36800-448
Allergy Relief	CETIRIZINE HCL	Publix Supermarkets, Inc.	cb70ca8b-847f-4122-b86f-bf5d39e2a83b	2022-11-08	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 56062-064
Allergy Relief	CETIRIZINE HCL	CVS PHARMACY, INC	ed8951a1-bd7e-439d-a427-685d56a9c9ad	2022-11-07	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 51316-064
careone allergy relief	CETIRIZINE HYDROCHLORIDE	Retail Business Services, LLC	6d94d302-b79a-4143-bb3c-c74da2a6a72e	2022-10-20	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 72476-623
Allergy Relief	CETIRIZINE HCL	Care One (Retail Business Services, LLC.)	04a6087e-d854-4e70-9d89-3971890a44a3	2022-10-20	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 72476-064
Good Sense All Day Allergy	CETIRIZINE HYDROCHLORIDE	L. Perrigo Company	5b1203c7-9678-4cee-9d7b-6510da295561	2022-09-08	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 0113-0981
dg health all day allergy	CETIRIZINE HYDROCHLORIDE	Dolgencorp Inc	6baa66e7-93df-43d9-a301-5d9c14274c99	2022-04-01	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 55910-934
allergy relief	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	268170c9-b6a7-4851-b7d3-33dd1d733e39	2022-03-07	Warnings	Exact identifier application applno (ANDA): 213105 application number: ANDA213105 ndc (product): 56062-111

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0981	Good Sense All Day Allergy	cetirizine hydrochloride	L. Perrigo Company	ANDA	Current
11822-0980	all day allergy	cetirizine hydrochloride	Rite Aid Corporation	ANDA	Current
21130-364	Allergy Relief	Cetirizine HCl	Safeway, Inc.	ANDA	Current
21130-364	Allergy Relief	Cetirizine HCl	Safeway, Inc.	ANDA	Current
36800-448	topcare all day allergy	cetirizine hydrochloride	Topco Associates LLC	ANDA	Current
37808-564	Allergy Relief	Cetirizine HCl	H E B	ANDA	Current
37808-564	Allergy Relief	Cetirizine HCl	H E B	ANDA	Current
51316-064	Allergy Relief	Cetirizine HCl	CVS PHARMACY, INC	ANDA	Current
51316-064	Allergy Relief	Cetirizine HCl	CVS PHARMACY, INC	ANDA	Current
51316-064	Allergy Relief	Cetirizine HCl	CVS PHARMACY, INC	ANDA	Current
55910-934	dg health all day allergy	cetirizine hydrochloride	Dolgencorp Inc	ANDA	Current
56062-064	Allergy Relief	Cetirizine HCl	Publix Supermarkets, Inc.	ANDA	Current
56062-064	Allergy Relief	Cetirizine HCl	Publix Supermarkets, Inc.	ANDA	Current
56062-111	allergy relief	cetirizine hydrochloride	Publix Super Markets Inc	ANDA	Current
59726-063	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-063	All Day Allergy Relief	Cetirizine HCl	P & L Development, LLC	ANDA	Current
59726-064	All Day Allergy Relief	Cetirizine HCL	P & L Development, LLC	ANDA	Current
59726-064	All Day Allergy Relief	Cetirizine HCL	P & L Development, LLC	ANDA	Current
59726-064	All Day Allergy Relief	Cetirizine HCL	P & L Development, LLC	ANDA	Current
72288-980	basic care all day allergy	cetirizine hydrochloride	Amazon.com Services LLC	ANDA	Current
72476-064	Allergy Relief	Cetirizine HCl	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-064	Allergy Relief	Cetirizine HCl	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-623	careone allergy relief	cetirizine hydrochloride	Retail Business Services, LLC	ANDA	Current
79481-0981	24 hour allergy	cetirizine hydrochloride	Meijer, Inc.	ANDA	Current
79481-0981	24 hour allergy	cetirizine hydrochloride	Meijer, Inc.	ANDA	Current
79903-084	All Day Allergy	Cetirizine HCl	WALMART INC.	ANDA	Current