Levocetirizine Dihydrochloride

Product NDC: 69230-321
11-digit product format: 692300321
Labeler code: 69230
Product ID: 69230-321_7ca0cee0-b628-4266-b361-ad5c52b6f11e
Type: HUMAN OTC DRUG
Nonproprietary name: Levocetirizine Dihydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Camber Consumer Care Inc
Application: ANDA213513
Marketing category: ANDA
Marketing start: 2020-10-28
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: 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	69230-321		UNFINISHED	Active or certified unfinished drug listing		2026-08-17
unfinished package	package	69230-321	69230-321-36	UNFINISHED	Active or certified unfinished drug listing		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 · 16 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	69230-321-36	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	69230-321-36	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	69230-321-36	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	69230-321-36	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	69230-321-36	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	69230-321-36	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	69230-321-36	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	69230-321-36	`68b1e3bced9e…`	`98a755eb8bc6…`

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
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
2026-08-18 06:07:40	2026-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Levocetirizine Dihydrochloride
Listing expiration: 2026-12-31

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
be72dafb-62ae-40b2-874f-1d8920fad19d	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	SPL version
69230-321-01	Levocetirizine Dihydrochloride	10 in 1 CARTON	TABLET, FILM COATED	10	4
69230-321-01	Levocetirizine Dihydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	4
69230-321-10	Levocetirizine Dihydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	4
69230-321-31	Levocetirizine Dihydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	4
69230-321-31	Levocetirizine Dihydrochloride	35 in 1 BOTTLE	TABLET, FILM COATED	35	4
69230-321-32	Levocetirizine Dihydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	4
69230-321-32	Levocetirizine Dihydrochloride	55 in 1 BOTTLE	TABLET, FILM COATED	55	4
69230-321-33	Levocetirizine Dihydrochloride	80 in 1 BOTTLE	TABLET, FILM COATED	80	4
69230-321-33	Levocetirizine Dihydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	4
69230-321-34	Levocetirizine Dihydrochloride	1 in 1 CARTON	TABLET, FILM COATED	1	4
69230-321-34	Levocetirizine Dihydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69230-321-10	EA - Each	69230-321	84a2a231-d14a-401d-9979-adec87d0ed53	1	2021-01-08
69230-321-31	EA - Each	69230-321	00dec7c6-cc7e-43c1-a75f-a56089546469	1	2021-01-08
69230-321-33	EA - Each	69230-321	33452538-def5-4491-9a09-fab29865059f	1	2021-01-08
69230-321-34	EA - Each	69230-321	2c505c0b-13ca-49dd-a26e-ed381568e575	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69230-321	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [CAMBER CONSUMER CARE INC]	4	Current NDC, Legacy NDC, 11 package rows	20201201_be72dafb-62ae-40b2-874f-1d8920fad19d.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 · 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 ndc (product): 69230-321

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	be72dafb-62ae-40b2-874f-1d8920fad19d	4
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	be72dafb-62ae-40b2-874f-1d8920fad19d	4
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	be72dafb-62ae-40b2-874f-1d8920fad19d	4
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
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	8c00c74f-4377-4f2c-943e-e55afa5a824f	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	8c00c74f-4377-4f2c-943e-e55afa5a824f	1
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	8c00c74f-4377-4f2c-943e-e55afa5a824f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69230-321-01	69230032101	10 BLISTER PACK in 1 CARTON (69230-321-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2020-10-28	0000-00-00	No	No	Current
69230-321-10	69230032110	1000 TABLET, FILM COATED in 1 BOTTLE (69230-321-10)		2020-10-28	0000-00-00	No	No	Current
69230-321-31	69230032131	1 BOTTLE in 1 CARTON (69230-321-31) / 35 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-10-28	0000-00-00	No	No	Current
69230-321-32	69230032132	1 BOTTLE in 1 CARTON (69230-321-32) / 55 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-10-28	0000-00-00	No	No	Current
69230-321-33	69230032133	1 BOTTLE in 1 CARTON (69230-321-33) / 80 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-10-28	0000-00-00	No	No	Current
69230-321-34	69230032134	1 BOTTLE in 1 CARTON (69230-321-34) / 180 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2020-10-28	0000-00-00	No	No	Current
69230-321-36	69230032136	10000 TABLET, FILM COATED in 1 BAG (69230-321-36)		16-JAN-25				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)	Sportpharm LLC	2026-02-14	HUMAN OTC DRUG LABEL	1
Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)	A-S Medication Solutions	2021-04-15	Human OTC Drug Label	3
Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)	Camber Consumer Care Inc \| Hetero Labs Limited Unit III	2020-11-30	Human OTC Drug Label	4