Levocetirizine Dihydrochloride

Product NDC: 68071-5107
11-digit product format: 680715107
Labeler code: 68071
Product ID: 68071-5107_1b469ff6-52ec-a91b-e063-6394a90a3123
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levocetirizine Dihydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA202046
Marketing category: ANDA
Marketing start: 2013-09-30
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

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 · 6 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
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	68071-5107-9	`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	68071-5107-9	`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	68071-5107-9	`1332a3947898…`	`d4bfe170f9cd…`

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
A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2013-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202046-001	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	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202046-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2013-09-17	`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	A202046-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202046-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202046-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202046-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202046-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202046-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202046-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202046-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202046-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202046-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202046-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202046-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202046-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202046-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202046-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202046-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202046-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202046-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202046-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202046-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202046-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202046-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202046-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202046-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202046-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202046-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202046-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202046-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202046-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202046-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202046-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202046-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202046-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202046-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202046-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202046-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202046-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202046-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202046-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202046-001	AB	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/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
97a67686-7e94-dd77-e053-2995a90a42c6	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-19	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
2023-01-30	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
2021-02-22	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
2021-01-29	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
68071-5107-9	Levocetirizine Dihydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5107	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240621_97a67686-7e94-dd77-e053-2995a90a42c6.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Micro Labs Limited	717eb542-3a05-485e-be76-3930efb40d33	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	e885f084-9ce2-4e0c-aadb-c9d651224e5b	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	97a67686-7e94-dd77-e053-2995a90a42c6	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046 ndc (product): 68071-5107
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	f10cfe9a-1884-4a65-b827-8fd781fb75c4	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Marlex Pharmaceuticals Inc	f5d8d6a6-6455-430b-8923-090e1ca2ae3b	2018-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202046 application number: ANDA202046

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	97a67686-7e94-dd77-e053-2995a90a42c6	4
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	97a67686-7e94-dd77-e053-2995a90a42c6	4
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	97a67686-7e94-dd77-e053-2995a90a42c6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5107-9	68071510709	90 TABLET, FILM COATED in 1 BOTTLE (68071-5107-9)	2019-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocetirizine Dihydrochloride	NuCare Pharmaceuticals,Inc.	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	4