Levocetirizine Dihydrochloride

Product NDC: 72789-023
11-digit product format: 727890023
Labeler code: 72789
Product ID: 72789-023_2d58a1fb-47b6-e4c8-e063-6294a90ad5f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levocetirizine Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA091264
Marketing category: ANDA
Marketing start: 2012-06-29
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 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
A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091264-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091264-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091264-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091264-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091264-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091264-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091264-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091264-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091264-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091264-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091264-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091264-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091264-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091264-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091264-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091264-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091264-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091264-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091264-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091264-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091264-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091264-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091264-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091264-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091264-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091264-001	AB	1	`cb3db0bc1861…`

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
57c7c673-790c-4158-87ca-7d8fb68c4286	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
72789-023-30	Levocetirizine Dihydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-023-30	EA - Each	72789-023	c0b631ba-b806-4b9f-b32e-ce7ddbc8879e	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-023	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 1 package rows	20250206_57c7c673-790c-4158-87ca-7d8fb68c4286.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	A-S Medication Solutions	d8b4b326-8be1-4404-9db7-636d86933139	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Northwind Health Company, LLC	f2b458d6-ac10-0fed-e053-2a95a90a0f9c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Camber Pharmaceuticals, Inc.	dd407f8f-140d-489f-b8c5-f6602d87e247	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	b7bbffcb-5f56-4735-998a-eadd07dfa2cb	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	57c7c673-790c-4158-87ca-7d8fb68c4286	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264 ndc (product): 72789-023
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	A-S Medication Solutions	7c163007-7e0d-4d55-8ae1-89defe55580f	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264

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	57c7c673-790c-4158-87ca-7d8fb68c4286	13
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	57c7c673-790c-4158-87ca-7d8fb68c4286	13
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	57c7c673-790c-4158-87ca-7d8fb68c4286	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72789-023-30	72789002330	30 TABLET in 1 BOTTLE, PLASTIC (72789-023-30)	30 tablet	2019-10-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	13