Levocetirizine Dihydrochloride

Product NDC: 0093-7701
11-digit product format: 000937701
Labeler code: 0093
Product ID: 0093-7701_27746553-05ff-43dd-a541-26bb9a6e9a4c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levocetirizine Dihydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA090199
Marketing category: ANDA
Marketing start: 2011-09-06
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
A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2011-08-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090199-001	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	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090199-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2011-08-22	`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	A090199-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090199-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090199-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090199-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090199-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090199-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090199-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090199-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090199-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090199-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090199-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090199-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090199-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090199-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090199-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090199-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090199-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090199-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090199-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090199-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090199-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090199-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090199-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090199-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090199-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090199-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090199-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090199-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090199-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090199-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090199-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090199-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090199-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090199-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090199-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090199-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090199-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090199-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090199-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090199-001	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
4f43d057-cba8-4366-86ba-4be361e4c71f	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
0093-7701-98	Levocetirizine Dihydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7701-98	EA - Each	0093-7701	6f6cd492-b322-4667-8b36-8e5e77ef0a10	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVOCETIRIZINE DIHYDROCHLORIDE	ACTIVE INGREDIENT	SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
LEVOCETIRIZINE	ACTIVE MOIETY	6U5EA9RT2O	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	7
LEVOCETIRIZINE DIHYDROCHLORIDE	ACTIVE INGREDIENT	SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
LEVOCETIRIZINE	ACTIVE MOIETY	6U5EA9RT2O	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	6
LEVOCETIRIZINE DIHYDROCHLORIDE	ACTIVE INGREDIENT	SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
LEVOCETIRIZINE	ACTIVE MOIETY	6U5EA9RT2O	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-7701	LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	19	Current NDC, Legacy NDC, 1 package rows	20221019_4f43d057-cba8-4366-86ba-4be361e4c71f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	344ba2d6-4e17-4cef-bd7b-248fbb1af3b6	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	4f43d057-cba8-4366-86ba-4be361e4c71f	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199 ndc (product): 0093-7701
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Proficient Rx LP	9f83891c-2466-4972-b0f4-b92cc7337be3	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2787aaa2-5209-f7d5-e063-6294a90a7103	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090199 application number: ANDA090199

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	4f43d057-cba8-4366-86ba-4be361e4c71f	21
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	4f43d057-cba8-4366-86ba-4be361e4c71f	21
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	4f43d057-cba8-4366-86ba-4be361e4c71f	21
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	344ba2d6-4e17-4cef-bd7b-248fbb1af3b6	19
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	344ba2d6-4e17-4cef-bd7b-248fbb1af3b6	19
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	344ba2d6-4e17-4cef-bd7b-248fbb1af3b6	19
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	ae073592-c187-4a6d-ae48-ffae2502b9eb	8
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	ae073592-c187-4a6d-ae48-ffae2502b9eb	8
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	ae073592-c187-4a6d-ae48-ffae2502b9eb	8
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	4a7e849d-6172-492a-bfac-ddf15e4a4216	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	2787aaa2-5209-f7d5-e063-6294a90a7103	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	9f83891c-2466-4972-b0f4-b92cc7337be3	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	4a7e849d-6172-492a-bfac-ddf15e4a4216	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	9f83891c-2466-4972-b0f4-b92cc7337be3	1
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	2787aaa2-5209-f7d5-e063-6294a90a7103	1
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	4a7e849d-6172-492a-bfac-ddf15e4a4216	1
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	2787aaa2-5209-f7d5-e063-6294a90a7103	1
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	9f83891c-2466-4972-b0f4-b92cc7337be3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-7701-98	00093770198	90 TABLET, FILM COATED in 1 BOTTLE (0093-7701-98)	2011-09-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	2025-09-15	HUMAN PRESCRIPTION DRUG LABEL	19
Levocetirizine Dihydrochloride	Teva Pharmaceuticals USA, Inc.	2025-08-11	HUMAN PRESCRIPTION DRUG LABEL	21
Levocetirizine Dihydrochloride	Proficient Rx LP	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	1
Levocetirizine Dihydrochloride	NuCare Pharmaceuticals, Inc.	2024-11-22	HUMAN PRESCRIPTION DRUG LABEL	1
Levocetirizine Dihydrochloride	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	8
Levocetirizine Dihydrochloride	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Levocetirizine Dihydrochloride	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-06-11	HUMAN PRESCRIPTION DRUG LABEL	1