Levocetirizine Dihydrochloride

Product NDC: 82804-232
11-digit product format: 828040232
Labeler code: 82804
Product ID: 82804-232_9f83891c-2466-4972-b0f4-b92cc7337be3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levocetirizine Dihydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090199
Marketing category: ANDA
Marketing start: 2011-09-06
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

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
A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-08-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090199-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090199-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090199-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090199-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090199-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090199-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090199-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090199-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090199-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090199-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090199-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090199-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090199-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090199-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090199-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090199-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090199-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090199-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090199-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090199-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090199-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090199-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090199-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090199-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090199-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090199-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090199-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090199-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090199-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090199-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090199-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090199-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090199-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090199-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090199-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090199-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090199-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090199-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090199-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090199-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090199-001	AB	1	`e64feba35796…`

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
9f83891c-2466-4972-b0f4-b92cc7337be3	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
82804-232-30	Levocetirizine Dihydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-232-30	EA - Each	82804-232	f3f6c476-bf78-4024-aeb5-78ffdcbdd3ac	1	2026-02-05

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	344ba2d6-4e17-4cef-bd7b-248fbb1af3b6	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4f43d057-cba8-4366-86ba-4be361e4c71f	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	9f83891c-2466-4972-b0f4-b92cc7337be3	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199 ndc (product): 82804-232
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2787aaa2-5209-f7d5-e063-6294a90a7103	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199

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	9f83891c-2466-4972-b0f4-b92cc7337be3	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	9f83891c-2466-4972-b0f4-b92cc7337be3	1
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	9f83891c-2466-4972-b0f4-b92cc7337be3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82804-232-30	82804023230	30 TABLET, FILM COATED in 1 BOTTLE (82804-232-30)	2025-07-30	No	No	Current