levocetirizine dihydrochloride

Product NDC: 68196-406
11-digit product format: 681960406
Labeler code: 68196
Product ID: 68196-406_35231680-b77b-f06e-11a5-a2107565afd1
Type: HUMAN OTC DRUG
Nonproprietary name: levocetirizine dihydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: SAM'S WEST INC
Application: ANDA210375
Marketing category: ANDA
Marketing start: 2020-06-24
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

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

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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210375-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-01-19	`cb3db0bc1861…`

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
bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68196-406-02	levocetirizine dihydrochloride	200 in 1 BOTTLE	TABLET, COATED	200		4
68196-406-20	levocetirizine dihydrochloride	2 in 1 CARTON	TABLET, COATED	2		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68196-406	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [SAM'S WEST INC ]	2	Current NDC, 2 package rows	20241020_bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1.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 ndc (product): 68196-406
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Target Corporation	7e933c85-96b0-b103-e26a-1aa8a1ded58e	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210375 application number: ANDA210375
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	bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1	4
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1	4
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68196-406-02	68196040602	200 in 1 BOTTLE					Historical
68196-406-20	68196040620	2 BOTTLE in 1 CARTON (68196-406-20) / 200 TABLET, COATED in 1 BOTTLE (68196-406-02)	2 bottle	2023-10-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocetirizine Dihydrochloride Tablets USP, 5 mg	SAM'S WEST INC	2026-01-19	HUMAN OTC DRUG LABEL	4