Cetirizine Hydrochloride

Product NDC: 67668-161
11-digit product format: 676680161
Labeler code: 67668
Product ID: 67668-161_89050554-8e16-41ce-88a5-30718b7f6f9c
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unique Pharmaceutical Laboratories
Application: ANDA077829
Marketing category: ANDA
Marketing start: 2009-10-01
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67668-161		I	Inactivated by FDA	2026-10-12
excluded package	package	67668-161	67668-161-00	I	Inactivated by FDA	2026-10-12
excluded package	package	67668-161	67668-161-30	I	Inactivated by FDA	2026-10-12
excluded package	package	67668-161	67668-161-45	I	Inactivated by FDA	2026-10-12

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 2 · 88 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	67668-161-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67668-161-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67668-161-00	`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	67668-161-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67668-161-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67668-161-00	`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	67668-161-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67668-161-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67668-161-00	`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	67668-161-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67668-161-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67668-161-00	`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	67668-161-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67668-161-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67668-161-00	`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	67668-161-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67668-161-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67668-161-00	`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	67668-161-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67668-161-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67668-161-00	`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	67668-161-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67668-161-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67668-161-00	`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	67668-161-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67668-161-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67668-161-00	`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	67668-161-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67668-161-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67668-161-00	`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	67668-161-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67668-161-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67668-161-00	`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	67668-161-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67668-161-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67668-161-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67668-161-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67668-161-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67668-161-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67668-161-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67668-161-45	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67668-161-00	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67668-161-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67668-161-45	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67668-161-00	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	RS	2009-08-26
A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL		2009-08-26
A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL		2009-08-26

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-002	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	RS	2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077829-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL		2009-08-26	`5bbf6a4d5a75…`

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
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67668-161-00	2020-01-31	C162847	48780-1	9d75b9d0-3175-f424-e053-dadaa90a57ce	Cetirizine Hydrochloride Tablets, 5 mg, Allergy
67668-161-30	2020-01-31	C162847	48780-1	9d75b9d0-3175-f424-e053-dadaa90a57ce	Cetirizine Hydrochloride Tablets, 5 mg, Allergy
67668-161-45	2020-01-31	C162847	48780-1	9d75b9d0-3175-f424-e053-dadaa90a57ce	Cetirizine Hydrochloride Tablets, 5 mg, Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67668-161-00	Cetirizine Hydrochloride	100 in 1 BOTTLE	TABLET	100	2
67668-161-30	Cetirizine Hydrochloride	30 in 1 BOTTLE	TABLET	30	2
67668-161-45	Cetirizine Hydrochloride	45 in 1 BOTTLE	TABLET	45	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2
Cetirizine	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2
hypromellose	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2
lactose	INACTIVE INGREDIENT	J2B2A4N98G	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2
povidone	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67668-161	CETIRIZINE HYDROCHLORIDE TABLET [UNIQUE PHARMACEUTICAL LABORATORIES]	2	Legacy NDC, 3 package rows	20091222_139536a1-b021-4ef3-902f-b618da5aaa44.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Umasuto, LLC	9af4ab23-d6d3-43f9-a026-76fd9771963f	2025-03-06	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	4b192084-dfdc-47bc-a968-6f49e137b248	2024-07-25	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Bryant Ranch Prepack	ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7	2024-05-21	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	6493d4f6-dead-45ec-ade1-28ce624af33d	2024-02-22	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	0b116de8-55c5-44dc-b0b6-f5a919e39a65	2019-10-01	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	9c2b97d9-9990-46ab-9027-c34ffb07ce8f	2019-10-01	Warnings	Exact identifier application applno (ANDA): 077829 application number: ANDA077829

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
1014676	cetirizine HCl 5 MG Oral Tablet	PSN	139536a1-b021-4ef3-902f-b618da5aaa44	2
1014676	cetirizine hydrochloride 5 MG Oral Tablet	SCD	139536a1-b021-4ef3-902f-b618da5aaa44	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67668-161-00	67668016100	100 in 1 BOTTLE	Historical
67668-161-30	67668016130	30 in 1 BOTTLE	Historical
67668-161-45	67668016145	45 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Tablets, 5 mg, Allergy	Unique Pharmaceutical Laboratories	2009-12-18	HUMAN OTC DRUG LABEL	2