levocetirizine dihydrochloride

Product NDC: 42543-712
11-digit product format: 425430712
Labeler code: 42543
Product ID: 42543-712_e0dc4ba0-8ea1-47c3-8bed-427969ca5c15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levocetirizine dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Vensun Pharmaceuticals, Inc.
Application: ANDA203646
Marketing category: ANDA
Marketing start: 2014-10-27
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
A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2014-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203646-001	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	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203646-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2014-09-09	`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	A203646-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203646-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203646-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203646-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203646-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203646-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203646-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203646-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203646-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203646-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203646-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203646-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203646-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203646-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203646-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203646-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203646-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203646-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203646-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203646-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203646-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203646-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203646-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203646-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203646-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203646-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203646-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203646-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203646-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203646-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203646-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203646-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203646-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203646-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203646-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203646-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203646-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203646-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203646-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203646-001	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
7a2ca8aa-ba0b-45b4-bdb3-651879350130	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
42543-712-03	levocetirizine dihydrochloride	300 in 1 BOTTLE	TABLET	300	10
42543-712-30	levocetirizine dihydrochloride	30 in 1 BOTTLE	TABLET	30	10
42543-712-90	levocetirizine dihydrochloride	90 in 1 BOTTLE	TABLET	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42543-712-90	EA - Each	42543-712	89e23f68-6765-40cf-9279-14e840cece23	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
levocetirizine dihydrochloride	ACTIVE INGREDIENT	SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1
levocetirizine	ACTIVE MOIETY	6U5EA9RT2O	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42543-712	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [VENSUN PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 3 package rows	20180723_7a2ca8aa-ba0b-45b4-bdb3-651879350130.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	8274ca80-e7d3-4f4f-9901-cc5c589b4fef	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	be58ca52-ab5d-4656-bfe0-bd5766235968	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	c79d3668-5243-4627-ad2b-cc7c045df120	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	c2dbf151-5b3d-5dfb-e053-2995a90a4c19	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Northwind Health Company, LLC	dae403cd-b6fc-7c50-e053-2995a90a95e3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Golden State Medical Supply, Inc.	163dcce7-4535-a596-e063-6394a90a634f	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	ScieGen Pharmaceuticals, Inc.	bd7fe481-dfe7-4dfd-aa05-6e2318a9234e	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Westminster Pharmaceuticals, LLC	85dcd6c0-7fb2-40b3-b07f-93bab169011d	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	8f308352-5854-409e-8bf7-bc9958cc3c5e	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	51d88b2a-d10d-4e7a-b874-98de48069223	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	4d0a0f8e-b298-46d2-b27d-0bb737507fed	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	7108ad0a-af1e-4172-b4ba-e5d9aaadfba7	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	1ceff0e6-1e66-4494-b986-1bd23eb6813e	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	b84ccb27-9c52-43b9-9a46-8f52a571045e	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	34541530-ae3b-4247-b08c-cd1c13e2e6a1	2019-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646
levocetirizine dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Vensun Pharmaceuticals, Inc.	7a2ca8aa-ba0b-45b4-bdb3-651879350130	2018-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203646 application number: ANDA203646 ndc (product): 42543-712

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	7a2ca8aa-ba0b-45b4-bdb3-651879350130	10
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	7a2ca8aa-ba0b-45b4-bdb3-651879350130	10
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	7a2ca8aa-ba0b-45b4-bdb3-651879350130	10
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	34541530-ae3b-4247-b08c-cd1c13e2e6a1	3
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	34541530-ae3b-4247-b08c-cd1c13e2e6a1	3
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	34541530-ae3b-4247-b08c-cd1c13e2e6a1	3
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	b84ccb27-9c52-43b9-9a46-8f52a571045e	2
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	b84ccb27-9c52-43b9-9a46-8f52a571045e	2
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	b84ccb27-9c52-43b9-9a46-8f52a571045e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42543-712-03	42543071203	300 TABLET in 1 BOTTLE (42543-712-03)	300 tablet	2014-10-27	0000-00-00	No	No	Current
42543-712-30	42543071230	30 TABLET in 1 BOTTLE (42543-712-30)	30 tablet	2014-10-27	0000-00-00	No	No	Current
42543-712-90	42543071290	90 TABLET in 1 BOTTLE (42543-712-90)	90 tablet	2014-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
levocetirizine dihydrochloride	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
levocetirizine dihydrochloride	Bryant Ranch Prepack	2019-06-11	HUMAN PRESCRIPTION DRUG LABEL	3
levocetirizine dihydrochloride	Vensun Pharmaceuticals, Inc. \| ScieGen Pharmaceuticals, Inc.	2018-07-13	HUMAN PRESCRIPTION DRUG LABEL	10