Cetirizine Hydrochloride Oral Solution

Product NDC: 13668-029
11-digit product format: 136680029
Labeler code: 13668
Product ID: 13668-029_d5f621e8-9a36-8add-e053-2a95a90a5ddf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cetirizine Hydrochloride Oral Solution
Dosage form: SOLUTION
Route: ORAL
Labeler: Torrent Pharma, Inc.
Application: ANDA078870
Marketing category: ANDA
Marketing start: 2018-05-01
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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13668-029		D	Discontinued by firm	2026-10-05
excluded product	product	13668-029		D	Discontinued by firm	2026-10-05
excluded product	product	13668-029		D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-01	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-05	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-25	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-30	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-02	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-03	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-04	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-06	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-07	D	Discontinued by firm	2026-10-05
excluded package	package	13668-029	13668-029-11	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 3 · 156 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
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	13668-029-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13668-029-04	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
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	13668-029-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13668-029-04	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
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	13668-029-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13668-029-04	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	13668-029-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13668-029-04	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
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	13668-029-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-029-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-029-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-029-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13668-029-07	`cfe11265f3b6…`	`090c488252e2…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-029-07	ML - Milliliter	13668-029	fad6bf63-01ec-4b00-be99-833ed90a4e02	1	2021-02-05

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-029-07	13668002907	120 mL in 1 BOTTLE (13668-029-07)	120 ml	2018-05-01	0000-00-00	No	No	Current
13668-029-11	13668002911	480 mL in 1 BOTTLE (13668-029-11)	480 ml	2021-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Oral Solution	Torrent Pharma, Inc. \| Torrent Pharma Inc \| Torrent Pharma Inc.	2022-01-19	HUMAN PRESCRIPTION DRUG LABEL	7