LEVOCETIRIZINE DIHYDROCHLORIDE

Product NDC: 70934-235
Requested package NDC: 70934-235-30
11-digit product format: 709340235
Labeler code: 70934
Product ID: 70934-235_b7c3b6c1-4a42-fbb5-e053-2a95a90acbe2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA205564
Marketing category: ANDA
Marketing start: 2019-01-15
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70934-235	70934-235-30	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2016-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205564-001	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	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205564-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2016-01-11	`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	A205564-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205564-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205564-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205564-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205564-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205564-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205564-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205564-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205564-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205564-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205564-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205564-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205564-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205564-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205564-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205564-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205564-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205564-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205564-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205564-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205564-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205564-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205564-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205564-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205564-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205564-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205564-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205564-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205564-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205564-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205564-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205564-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205564-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205564-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205564-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205564-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205564-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205564-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205564-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205564-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760	Product name	7	20190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70934-235-30	2022-01-28	C162847	48780-1	d6a99b39-8170-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS. LEVOCETIRIZINE dihydrochloride tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-235-30	LEVOCETIRIZINE DIHYDROCHLORIDE	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-235	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20210101_87c4d9c1-db12-9b61-e053-2995a90abfec.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	Bryant Ranch Prepack	1b593c65-2866-45d9-9c94-ac181f4cbc51	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205564 application number: ANDA205564
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Macleods Pharmaceuticals Limited	8a3c06a5-4a9a-4205-8ae7-c58efeb73c58	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205564 application number: ANDA205564
LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5d6941c7-ef0a-48d3-93dc-53bc2c9789de	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205564 application number: ANDA205564

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	87c4d9c1-db12-9b61-e053-2995a90abfec	2
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	87c4d9c1-db12-9b61-e053-2995a90abfec	2
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	87c4d9c1-db12-9b61-e053-2995a90abfec	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-235-30	70934023530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-235-30)	2019-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVOCETIRIZINE DIHYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-31	HUMAN PRESCRIPTION DRUG LABEL	2