Cetirizine Hydrochloride

Product NDC: 13668-596
Requested package NDC: 13668-596-11
11-digit product format: 136680596
Labeler code: 13668
Product ID: 13668-596_d6e3bd11-efa1-cbee-e053-2995a90ae5ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Torrent Pharma Inc.
Application: ANDA078870
Marketing category: ANDA
Marketing start: 2018-07-13
Marketing end: 0000-00-00
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	13668-596	13668-596-11	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

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

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
A078870-001	CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA		2009-04-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078870-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL	AA	2009-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2009-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2009-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2009-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2009-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2009-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2009-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL	AA	2009-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		2009-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078870-001	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SYRUP / ORAL		2009-04-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078870-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078870-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078870-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078870-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078870-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078870-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078870-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078870-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078870-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078870-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078870-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078870-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078870-001	AA	1	`79d66fd596c7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078870-001	AA	1	`5c6f7cd8ea54…`
2019-12-13 00:20 UTC	2019-12	A078870-001	AA	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A078870-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078870-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078870-001	AA	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
13668-596-07	2022-01-31	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP For Oral Use Rx Only
13668-596-11	2022-01-31	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP For Oral Use Rx Only
13668-596-07	2022-01-28	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP For Oral Use Rx Only
13668-596-11	2022-01-28	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP For Oral Use Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-596-07	ML - Milliliter	13668-596	05e82206-be9b-4c33-bf9f-eb1de420baa2	1	2018-08-13

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 Oral Solution	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION	APOZEAL PHARMACEUTICALS INC	9c6a440b-bd0f-414b-bab3-3b2f57c479d7	2026-01-06	Adverse reactions	Exact identifier application applno (ANDA): 078870 application number: ANDA078870
Cetirizine Hydrochloride Oral Solution	CETIRIZINE HYDROCHLORIDE ORAL SOLUTION	Preferred Pharmaceuticals Inc.	a03d33dc-a84c-4ab7-88a8-77333bfcb8e7	2025-06-27	Adverse reactions	Exact identifier application applno (ANDA): 078870 application number: ANDA078870

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	95d73b05-1b3f-404e-be2e-5efc333748b7	3
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	95d73b05-1b3f-404e-be2e-5efc333748b7	3
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	95d73b05-1b3f-404e-be2e-5efc333748b7	3
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	95d73b05-1b3f-404e-be2e-5efc333748b7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-596-11	13668059611	480 mL in 1 BOTTLE (13668-596-11)	480 ml	2018-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP For Oral Use Rx Only	Torrent Pharma Inc.	2022-01-31	HUMAN PRESCRIPTION DRUG LABEL	3
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION, USP For Oral Use Rx Only	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	3