Cetirizine Hydrochloride

Product NDC: 51660-939
11-digit product format: 516600939
Labeler code: 51660
Product ID: 51660-939_2a87ee90-da59-4e35-9cda-27759ba080d4
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Ohm Laboratories Inc.
Application: ANDA077498
Marketing category: ANDA
Marketing start: 2007-12-27
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	51660-939		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	51660-939	51660-939-04	UNFINISHED	Active or certified unfinished drug listing		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 · 4 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	51660-939-04	`a6255e0c9aa5…`	`a0211a219f2e…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	51660-939-04	`05c55d027831…`	`ca05dca9dc4c…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27
A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	5MG	TABLET / ORAL	2007-12-27
A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE	10MG	TABLET / ORAL	2007-12-27

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077498-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077498-002	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077498-003	CETIRIZINE HYDROCHLORIDE HIVES	5MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077498-004	CETIRIZINE HYDROCHLORIDE HIVES	10MG	TABLET / ORAL	2007-12-27	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cetirizine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	10 mg/1

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
1014678	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
161c4122-2c89-46e6-a6ae-db088087330d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51660-939-01	Cetirizine Hydrochloride	100 in 1 BOTTLE	TABLET	100	8
51660-939-13	Cetirizine Hydrochloride	120 in 1 BOTTLE	TABLET	120	8
51660-939-30	Cetirizine Hydrochloride	30 in 1 BOTTLE	TABLET	30	8
51660-939-53	Cetirizine Hydrochloride	300 in 1 BOTTLE	TABLET	300	8
51660-939-54	Cetirizine Hydrochloride	14 in 1 BLISTER PACK	TABLET	14	8
51660-939-90	Cetirizine Hydrochloride	90 in 1 BOTTLE	TABLET	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51660-939-01	EA - Each	51660-939	c6152a9c-4004-45e7-a393-318a7dc523ad	1	2018-09-05
51660-939-30	EA - Each	51660-939	6d3f9435-6ac5-4598-834c-7031f6d208dc	1	2015-04-03
51660-939-53	EA - Each	51660-939	8cd8fd29-46e6-4c8a-9d09-89f40c703bca	1	2021-06-02
51660-939-54	EA - Each	51660-939	9548bacb-ebe1-49df-a60f-57726490d5e6	1	2013-07-02
51660-939-90	EA - Each	51660-939	de021969-bdaa-424c-8b8b-ca61a2b68df8	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	2
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51660-939	CETIRIZINE HYDROCHLORIDE TABLET [OHM LABORATORIES INC.]	8	Current NDC, Legacy NDC, 6 package rows	20210525_161c4122-2c89-46e6-a6ae-db088087330d.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sportpharm LLC	357523b6-618b-4bff-a80d-c62e72a0804e	2026-05-08	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	a7da81e1-8865-45c9-83c7-32fb8032ca2e	2026-03-19	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marlex Pharmaceuticals, Inc	eb917099-fecf-6b55-e053-2995a90aaafa	2025-09-23	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	d0d8b376-9001-8776-e053-2a95a90ae651	2024-08-12	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	15eaa0d1-d18d-72b1-e063-6394a90a8a94	2024-04-12	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Proficient Rx LP	d14feb90-3ca2-4d5b-825c-25fc2252ca38	2022-06-01	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Ohm Laboratories Inc.	161c4122-2c89-46e6-a6ae-db088087330d	2021-05-21	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498 ndc (product): 51660-939
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Publix Super Markets Inc	a0a063a1-e067-480e-afab-7f01165025f4	2019-08-19	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Consortium, LLC	9d7d2342-a594-4851-810b-b7bce1bd07dc	2018-08-24	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Valu Merchandisers Company	4a8d2887-8ac3-4d54-9e67-4a271d416426	2018-08-23	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Quality Choice Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	2e8cc4e3-8386-42de-801f-fef37f612849	2018-08-22	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Marc Glassman, Inc.	f30900e6-425f-43e0-81b6-1fa3bd321f0b	2018-06-20	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	LIDL US, LLC	a210d6b7-0829-4120-bb6d-fee0c2e57b26	2018-01-09	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	FAMILY DOLLAR SERVICES, INC	b326dacc-6123-47a7-9fde-6909db1d780b	2018-01-08	Warnings	Exact identifier application applno (ANDA): 077498 application number: ANDA077498

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
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	a7da81e1-8865-45c9-83c7-32fb8032ca2e	15
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	a7da81e1-8865-45c9-83c7-32fb8032ca2e	15
1014678	cetirizine HCl 10 MG Oral Tablet	SY	a7da81e1-8865-45c9-83c7-32fb8032ca2e	15
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	161c4122-2c89-46e6-a6ae-db088087330d	8
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	161c4122-2c89-46e6-a6ae-db088087330d	8
1014678	cetirizine HCl 10 MG Oral Tablet	SY	161c4122-2c89-46e6-a6ae-db088087330d	8
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	d14feb90-3ca2-4d5b-825c-25fc2252ca38	5
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	d14feb90-3ca2-4d5b-825c-25fc2252ca38	5
1014678	cetirizine HCl 10 MG Oral Tablet	SY	d14feb90-3ca2-4d5b-825c-25fc2252ca38	5
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	9ff21853-ff3d-4b0e-a4a6-342d0ef459ae	3
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	9ff21853-ff3d-4b0e-a4a6-342d0ef459ae	3
1014678	cetirizine HCl 10 MG Oral Tablet	SY	9ff21853-ff3d-4b0e-a4a6-342d0ef459ae	3
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	d0d8b376-9001-8776-e053-2a95a90ae651	2
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	d0d8b376-9001-8776-e053-2a95a90ae651	2
1014678	cetirizine HCl 10 MG Oral Tablet	SY	d0d8b376-9001-8776-e053-2a95a90ae651	2
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	296e5977-0e8c-4147-a94d-374eb913ab51	1
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	357523b6-618b-4bff-a80d-c62e72a0804e	1
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	1cfedef0-7cd3-8cd9-e063-6294a90a525d	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	357523b6-618b-4bff-a80d-c62e72a0804e	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	296e5977-0e8c-4147-a94d-374eb913ab51	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	1cfedef0-7cd3-8cd9-e063-6294a90a525d	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	357523b6-618b-4bff-a80d-c62e72a0804e	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	296e5977-0e8c-4147-a94d-374eb913ab51	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	1cfedef0-7cd3-8cd9-e063-6294a90a525d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51660-939-01	51660093901	100 TABLET in 1 BOTTLE (51660-939-01)	100 tablet	2007-12-27	0000-00-00	No	No	Current
51660-939-04	51660093904	5000 TABLET in 1 BAG (51660-939-04)	5000 tablet	28-NOV-24				Current
51660-939-13	51660093913	120 TABLET in 1 BOTTLE (51660-939-13)	120 tablet	2007-12-27	0000-00-00	No	No	Current
51660-939-30	51660093930	30 TABLET in 1 BOTTLE (51660-939-30)	30 tablet	2007-12-27	0000-00-00	No	No	Current
51660-939-53	51660093953	300 TABLET in 1 BOTTLE (51660-939-53)	300 tablet	2007-12-27	0000-00-00	No	No	Current
51660-939-54	51660093954	14 TABLET in 1 BLISTER PACK (51660-939-54)	14 tablet	2007-12-27	0000-00-00	No	No	Current
51660-939-90	51660093990	90 TABLET in 1 BOTTLE (51660-939-90)	90 tablet	2007-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride	Sportpharm LLC	2026-05-08	HUMAN OTC DRUG LABEL	1
Cetirizine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2026-03-19	HUMAN OTC DRUG LABEL	15
Cetirizine Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-08-12	HUMAN OTC DRUG LABEL	2
Cetirizine Hydrochloride	RedPharm Drug	2024-07-11	HUMAN OTC DRUG LABEL	1
Drug Facts	Proficient Rx LP	2022-06-01	HUMAN OTC DRUG LABEL	5
Cetirizine Hydrochloride	A-S Medication Solutions	2021-06-14	HUMAN OTC DRUG LABEL	3
Cetirizine Hydrochloride	Ohm Laboratories Inc. \| Sun Pharmaceutical Industries Inc.	2021-05-21	HUMAN OTC DRUG LABEL	8
Drug Facts	Rebel Distributors Corp	2012-02-29	HUMAN OTC DRUG LABEL	1