levocetirizine dihydrochloride

Product NDC: 45802-680
11-digit product format: 458020680
Labeler code: 45802
Product ID: 45802-680_1a939b38-64a2-4238-816d-4c01075e5cbe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levocetirizine dihydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Padagis Israel Pharmaceuticals Ltd
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 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
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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091263-001	LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	SOLUTION / ORAL	AA	RS	2011-11-07	`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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091263-001	AA	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/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
2965ef46-18db-4615-9dce-bfb0f0b3366a	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
45802-680-28	levocetirizine dihydrochloride	148 mL in 1 BOTTLE	SOLUTION	148		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-680-28	ML - Milliliter	45802-680	54726ce9-a98f-4e7b-8355-3a2b40451077	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOCETIRIZINE DIHYDROCHLORIDE	ACTIVE INGREDIENT	SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
LEVOCETIRIZINE	ACTIVE MOIETY	6U5EA9RT2O	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PERRIGO NEW YORK INC]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-680	LEVOCETIRIZINE DIHYDROCHLORIDE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]	16	Current NDC, Legacy NDC, 1 package rows	20221221_2965ef46-18db-4615-9dce-bfb0f0b3366a.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 ndc (product): 45802-680
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

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	628c26f0-f6bb-4658-ba50-8ca04cd859cb	108
855168	levocetirizine dihydrochloride 0.5 MG/ML Oral Solution	SCD	628c26f0-f6bb-4658-ba50-8ca04cd859cb	108
855168	levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution	SY	628c26f0-f6bb-4658-ba50-8ca04cd859cb	108
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
855168	levocetirizine dihydrochloride 2.5 MG in 5 mL Oral Solution	PSN	2965ef46-18db-4615-9dce-bfb0f0b3366a	18
855168	levocetirizine dihydrochloride 0.5 MG/ML Oral Solution	SCD	2965ef46-18db-4615-9dce-bfb0f0b3366a	18
855168	levocetirizine dihydrochloride 2.5 MG per 5 ML Oral Solution	SY	2965ef46-18db-4615-9dce-bfb0f0b3366a	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-680-28	45802068028	148 mL in 1 BOTTLE (45802-680-28)	148 ml	2011-11-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
levocetirizine dihydrochloride	Padagis Israel Pharmaceuticals Ltd	2025-07-31	HUMAN PRESCRIPTION DRUG LABEL	18
levocetirizine dihydrochloride	Bryant Ranch Prepack	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	108
levocetirizine dihydrochloride	Bryant Ranch Prepack	2023-09-26	HUMAN PRESCRIPTION DRUG LABEL	100