levocetirizine dihydrochloride

Product NDC: 11673-847
Requested package NDC: 11673-847-79
11-digit product format: 116730847
Labeler code: 11673
Product ID: 11673-847_35fedca9-3c7b-5252-e99f-a62f55564e69
Type: HUMAN OTC DRUG
Nonproprietary name: levocetirizine dihydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Target Corporation
Application: ANDA210375
Marketing category: ANDA
Marketing start: 2018-12-31
Substance: LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength: 5 mg/1
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

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	11673-847	11673-847-79	D	Discontinued by firm		2026-08-17

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 · 10 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2018-01-19

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: levocetirizine dihydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOCETIRIZINE DIHYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOD6A38AGA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855172	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
7e933c85-96b0-b103-e26a-1aa8a1ded58e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760	Product name	7	20190702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11673-847	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [TARGET CORPORATION]	7	Current NDC, Legacy NDC	20241024_7e933c85-96b0-b103-e26a-1aa8a1ded58e.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	1f722b84-08de-7e6a-41ac-2c9d9bb9fb43	2026-06-04	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	KROGER COMPANY	e47658af-e0f3-5765-f568-300ba407dc29	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	CVS PHARMACY	c8681ca3-27b4-6738-af72-599ff05f2ec8	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Walgreens Company	766b8836-74b8-8af7-b900-b813b4fc175b	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
24HR Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	6ba57f12-fd25-c4a6-ff2d-2955116f84c4	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Albertsons Companies	e1a6932b-d076-6573-5b88-7b06c3a91681	2026-01-20	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	SAM'S WEST INC	bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Target Corporation	7e933c85-96b0-b103-e26a-1aa8a1ded58e	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375 ndc (package): 11673-847-79 ndc (product): 11673-847 ndc11 (package): 11673084779
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	HEB	b13ab6fc-4fec-c870-2c5f-b5e31dec722a	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	fb0a3619-9d5b-5c58-82f3-31f031672f33	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Walmart Inc.	82da5fa1-3633-2c48-32b9-d15482f308a1	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Rite Aid Corporation	fafc8149-d59a-1253-ae79-f33a088e3769	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	BJWC (Berkley & Jensen / BJ'S)	0216f644-767c-ae88-f48f-cd29ac1547ed	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Chain Drug Marketing Association INC	61fb8bef-d868-adee-3237-d3268d603ba6	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	AMERISOURCEBERGEN DRUG CORPORATION	fdf54de3-16a9-3b28-b4c4-d745322b3d3c	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	5036170d-7eeb-65a8-8473-7d98aeb51ee4	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE	130018-87-0	LEVOCETIRIZINE DIHYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	7e933c85-96b0-b103-e26a-1aa8a1ded58e	9
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	7e933c85-96b0-b103-e26a-1aa8a1ded58e	9
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	7e933c85-96b0-b103-e26a-1aa8a1ded58e	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11673-847-79	11673084779	2 BLISTER PACK in 1 BLISTER PACK (11673-847-79) > 5 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2018-12-31	0000-00-00	No	No	Current