Levocetirizine Dihydrochloride

Product NDC: 10135-639
11-digit product format: 101350639
Labeler code: 10135
Product ID: 10135-639_f380ef7e-eece-412d-b50c-deae2f6098d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levocetirizine Dihydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA202046
Marketing category: ANDA
Marketing start: 2018-09-01
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 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
f5d8d6a6-6455-430b-8923-090e1ca2ae3b	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	Strength	SPL version
10135-639-30	Levocetirizine Dihydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
10135-639-90	Levocetirizine Dihydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-639-30	EA - Each	10135-639	5b68684e-85c4-4ef5-a57a-0379875fdd8c	1	2018-10-11
10135-639-90	EA - Each	10135-639	91b8fd18-7de7-40cc-b1da-1715a2249c57	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-639	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1	Current NDC, Legacy NDC, 2 package rows	20180901_f5d8d6a6-6455-430b-8923-090e1ca2ae3b.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
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 ndc (product): 10135-639

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	f5d8d6a6-6455-430b-8923-090e1ca2ae3b	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	f5d8d6a6-6455-430b-8923-090e1ca2ae3b	1
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	f5d8d6a6-6455-430b-8923-090e1ca2ae3b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-639-30	10135063930	30 TABLET, FILM COATED in 1 BOTTLE (10135-639-30)	2018-09-01	0000-00-00	No	No	Current
10135-639-90	10135063990	90 TABLET, FILM COATED in 1 BOTTLE (10135-639-90)	2018-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocetirizine Dihydrochloride	Marlex Pharmaceuticals Inc	2018-01-01	HUMAN PRESCRIPTION DRUG LABEL	1