Cetirizine Hydrochloride

Product NDC: 68788-8523
Requested package NDC: 68788-8523-1
11-digit product format: 687888523
Labeler code: 68788
Product ID: 68788-8523_883939e1-51a7-4b72-8a2b-09e8596cb799
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetirizine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA078398
Marketing category: ANDA
Marketing start: 2023-09-13
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078398-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078398-001	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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	RS	2008-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078398-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	RS	2008-06-17	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078398-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078398-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078398-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078398-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078398-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078398-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078398-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078398-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078398-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078398-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078398-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078398-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078398-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078398-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078398-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078398-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078398-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078398-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078398-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078398-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078398-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078398-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078398-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078398-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078398-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078398-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078398-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078398-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078398-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078398-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078398-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078398-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078398-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078398-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078398-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078398-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078398-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078398-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078398-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078398-001	AA	1	`f41ea6bd6efb…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	1 mg/mL

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
1014673	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
e874264a-becc-45d0-b934-779eab5f5085	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68788-8523-1	Cetirizine Hydrochloride	1 in 1 CARTON	SOLUTION	1		4
68788-8523-1	Cetirizine Hydrochloride	120 mL in 1 BOTTLE	SOLUTION	120		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8523	CETIRIZINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, 2 package rows	20250227_e874264a-becc-45d0-b934-779eab5f5085.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e874264a-becc-45d0-b934-779eab5f5085	2026-03-25	Adverse reactions	Exact identifier application applno (ANDA): 078398 application number: ANDA078398 ndc (package): 68788-8523-1 ndc (product): 68788-8523 ndc11 (package): 68788852301
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e	2025-08-31	Adverse reactions	Exact identifier application applno (ANDA): 078398 application number: ANDA078398

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
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	e874264a-becc-45d0-b934-779eab5f5085	4
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	e874264a-becc-45d0-b934-779eab5f5085	4
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	e874264a-becc-45d0-b934-779eab5f5085	4
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	e874264a-becc-45d0-b934-779eab5f5085	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8523-1	68788852301	1 BOTTLE in 1 CARTON (68788-8523-1) / 120 mL in 1 BOTTLE	1 bottle	2023-09-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL	Preferred Pharmaceuticals Inc.	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	4