Cetirizine Hydrochloride

Product NDC: 54838-571
11-digit product format: 548380571
Labeler code: 54838
Product ID: 54838-571_083a0699-dc95-44fc-880d-168a6058d0a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA078876
Marketing category: ANDA
Marketing start: 2012-05-11
Marketing end: 2023-11-30
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54838-571		D	Discontinued by firm	2026-08-03
excluded package	package	54838-571	54838-571-40	D	Discontinued by firm	2026-08-03
excluded package	package	54838-571	54838-571-80	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54838-571-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54838-571-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54838-571-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54838-571-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54838-571-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54838-571-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54838-571-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54838-571-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54838-571-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54838-571-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54838-571-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54838-571-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54838-571-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54838-571-40	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54838-571-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54838-571-40	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54838-571-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54838-571-40	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54838-571-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54838-571-40	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54838-571-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54838-571-40	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54838-571-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54838-571-40	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078876-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2012-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A078876-001	AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2012-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078876-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2012-05-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078876-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078876-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078876-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078876-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078876-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078876-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078876-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078876-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078876-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078876-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078876-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078876-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078876-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078876-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078876-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078876-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078876-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078876-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078876-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078876-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078876-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078876-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078876-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078876-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078876-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078876-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078876-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078876-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078876-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078876-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078876-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078876-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078876-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078876-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078876-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078876-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078876-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078876-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078876-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078876-001	AA	1	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10
Cetirizine	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10
acetic acid	INACTIVE INGREDIENT	Q40Q9N063P	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10
calcium acetate	INACTIVE INGREDIENT	Y882YXF34X	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10
water	INACTIVE INGREDIENT	059QF0KO0R	CETIRIZINE HYDROCHLORIDE SYRUP [SILARX PHARMACEUITCALS, INC]	10

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
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aventura Pharmaceuticals, LLC	aeb73ab9-3b05-4062-a7fd-352cf2094a56	2025-10-02	Adverse reactions	Exact identifier application applno (ANDA): 078876 application number: ANDA078876
Cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	a9b21d71-106e-4bd5-aaab-9254c8a44e0d	2025-02-12	Adverse reactions	Exact identifier application applno (ANDA): 078876 application number: ANDA078876
Cetirizine Hydrochloride Oral Solution	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION	Chartwell RX, LLC	41dc7107-a2d2-4519-ac6f-cbed9f07e9bf	2023-10-05	Adverse reactions	Exact identifier application applno (ANDA): 078876 application number: ANDA078876

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54838-571-40	54838057140	120 mL in 1 BOTTLE, PLASTIC (54838-571-40)	120 ml	2012-05-11	2023-11-30	No	No	Current
54838-571-80	54838057180	473 mL in 1 BOTTLE, PLASTIC (54838-571-80)	473 ml	2012-05-11	2023-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Oral Solution, USP For Oral Use Rx only	Lannett Company, Inc.	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	17