levocetirizine dihydrochloride

Product NDC: 72162-1424
11-digit product format: 721621424
Labeler code: 72162
Product ID: 72162-1424_38cb0ddb-5227-4066-9b07-a1feececf7a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levocetirizine dihydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091263
Marketing category: ANDA
Marketing start: 2011-11-07
Substance: LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength: .5 mg/mL
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
A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091263-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`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	A091263-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091263-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091263-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091263-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091263-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091263-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091263-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091263-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091263-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091263-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091263-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091263-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091263-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091263-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091263-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091263-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091263-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091263-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091263-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091263-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091263-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091263-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091263-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091263-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091263-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091263-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091263-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091263-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091263-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091263-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091263-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091263-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091263-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091263-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091263-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091263-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091263-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091263-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091263-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091263-001	AA	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/mL

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
855168	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
a9e7152c-0aa3-4355-8805-307e510ac86b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760	Product name	7	20190702
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-1424-2	levocetirizine dihydrochloride	148 mL in 1 BOTTLE	SOLUTION	148		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1424-2	ML - Milliliter	72162-1424	d1fee09c-0791-48d7-87d5-a5c2ec716b97	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1424	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]	100	Current NDC, 1 package rows	20230927_a9e7152c-0aa3-4355-8805-307e510ac86b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	2965ef46-18db-4615-9dce-bfb0f0b3366a	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091263 application number: ANDA091263
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	628c26f0-f6bb-4658-ba50-8ca04cd859cb	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091263 application number: ANDA091263
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	a9e7152c-0aa3-4355-8805-307e510ac86b	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091263 application number: ANDA091263 ndc (product): 72162-1424

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
855168	levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution	PSN	a9e7152c-0aa3-4355-8805-307e510ac86b	100
855168	levocetirizine dihydrochloride 0.5 MG/ML Oral Solution	SCD	a9e7152c-0aa3-4355-8805-307e510ac86b	100
855168	levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution	SY	a9e7152c-0aa3-4355-8805-307e510ac86b	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-1424-2	72162142402	148 mL in 1 BOTTLE (72162-1424-2)	148 ml	2023-09-26	No	No	Current