Levocetirizine Dihydrochloride

Product NDC: 50090-5341
Requested package NDC: 50090-5341-0
11-digit product format: 500905341
Labeler code: 50090
Product ID: 50090-5341_ec104719-030c-4cd3-bdf8-09e2ce339eb8
Type: HUMAN OTC DRUG
Nonproprietary name: Levocetirizine Dihydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA213513
Marketing category: ANDA
Marketing start: 2020-10-28
Marketing end: 0000-00-00
Substance: LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	50090-5341	50090-5341-0	I	Inactivated by FDA		2026-08-03

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
A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2020-04-29

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.

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	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goodmeds Levocetirizine Dihydrochloride 5mg 365 count	LEVOCETIRIZINE DIHYDROCHLORIDE 5MG	Cabinet Health P.B.C.	54f34304-952e-2f07-e063-6394a90a80ee	2026-06-23	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Farmacias De Similares TX LLC	4ed17484-5609-d993-e063-6294a90a82a2	2026-04-06	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Curist Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG	Little Pharma, Inc.	f2a2a5bc-2efa-c550-e053-2a95a90a55ff	2026-03-05	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Sportpharm LLC	8c00c74f-4377-4f2c-943e-e55afa5a824f	2026-02-14		Exact identifier application applno (ANDA): 213513 application number: ANDA213513
ALLERGY RELIEF	LEVOCETIRIZINE DIHYDROCHLORIDE	YYBA CORP	8ee69332-742d-4071-95df-84bc42e170e7	2025-12-03	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Curist Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG	Little Pharma, Inc.	feabf140-e283-dcd5-e053-6394a90a2917	2025-04-16	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Allery Relief 24HR	ALLERY RELIEF 24HR	Allegiant Health	c523c210-b1c4-4049-9c72-2b31c9c93137	2024-04-02	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Camber Consumer Care Inc	be72dafb-62ae-40b2-874f-1d8920fad19d	2020-11-30		Exact identifier application applno (ANDA): 213513 application number: ANDA213513

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5341-0	2023-01-30	C162847	48780-1	f386c64a-328b-0266-e053-dadaa90a7c1a	Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)
50090-5341-1	2023-01-30	C162847	48780-1	f386c64a-328b-0266-e053-dadaa90a7c1a	Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5341-0	Levocetirizine Dihydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
50090-5341-1	Levocetirizine Dihydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5341	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20210417_3fad12b0-1bff-4899-99bb-0608b42d3be3.zip

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	3fad12b0-1bff-4899-99bb-0608b42d3be3	3
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	3fad12b0-1bff-4899-99bb-0608b42d3be3	3
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	3fad12b0-1bff-4899-99bb-0608b42d3be3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5341-0	50090534100	30 TABLET, FILM COATED in 1 BOTTLE (50090-5341-0)	2020-11-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)	A-S Medication Solutions	2021-04-15	Human OTC Drug Label	3