Levocetirizine Dihydrochloride

Product NDC: 69117-1000
11-digit product format: 691171000
Labeler code: 69117
Product ID: 69117-1000_9c134fe5-26a3-6bb3-e053-2995a90a2ceb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levocetirizine Dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: YILING PHARMACEUTICAL, INC.
Application: ANDA203646
Marketing category: ANDA
Marketing start: 2017-03-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69117-1000		I	Inactivated by FDA		2026-08-07
excluded package	package	69117-1000	69117-1000-1	I	Inactivated by FDA		2026-08-07

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69117-1000-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69117-1000-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69117-1000-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69117-1000-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69117-1000-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69117-1000-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69117-1000-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69117-1000-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69117-1000-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69117-1000-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69117-1000-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69117-1000-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69117-1000-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69117-1000-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69117-1000-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69117-1000-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69117-1000-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69117-1000-1	`bd6a592717d7…`	`303034d00443…`

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…`

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
69117-1000-1	2022-01-28	C162847	48780-1	d6a99b39-8677-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
69117-1000-1	Levocetirizine Dihydrochloride	90 in 1 BOTTLE	TABLET	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69117-1000-1	EA - Each	69117-1000	0ccdb6ac-10b7-4fef-b8b6-89c9e55eb96f	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69117-1000	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [YILING PHARMACEUTICAL, INC.]	4	Legacy NDC, 1 package rows	20200114_4aa6f67e-5331-661b-e054-00144ff88e88.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

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	4aa6f67e-5331-661b-e054-00144ff88e88	4
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	4aa6f67e-5331-661b-e054-00144ff88e88	4
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	4aa6f67e-5331-661b-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69117-1000-1	69117100001	90 TABLET in 1 BOTTLE (69117-1000-1)	90 tablet	2017-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocetirizine Dihydrochloride	AvKARE, Inc.	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	7
Levocetirizine Dihydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-03-21	HUMAN PRESCRIPTION DRUG LABEL	1
Levocetirizine Dihydrochloride	YILING PHARMACEUTICAL, INC. \| ScieGen Pharmaceuticals, Inc.	2020-01-13	HUMAN PRESCRIPTION DRUG LABEL	4