Application 091264

Type: ANDA
Sponsor: HETERO LABS LTD III

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	TABLET;ORAL	5MG	No	No

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
A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB		2012-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091264-001	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	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091264-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	AB	2012-06-29	`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	A091264-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091264-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091264-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091264-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091264-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091264-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091264-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091264-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091264-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091264-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091264-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091264-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091264-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091264-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091264-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091264-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091264-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091264-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091264-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091264-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091264-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091264-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091264-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091264-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091264-001	AB	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	A-S Medication Solutions	d8b4b326-8be1-4404-9db7-636d86933139	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264 ndc (product): 50090-1430
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Northwind Health Company, LLC	f2b458d6-ac10-0fed-e053-2a95a90a0f9c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Camber Pharmaceuticals, Inc.	dd407f8f-140d-489f-b8c5-f6602d87e247	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264 ndc (product): 31722-551
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Bryant Ranch Prepack	b7bbffcb-5f56-4735-998a-eadd07dfa2cb	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264 ndc (product): 71335-0789
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	57c7c673-790c-4158-87ca-7d8fb68c4286	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264 ndc (product): 72789-023
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	A-S Medication Solutions	7c163007-7e0d-4d55-8ae1-89defe55580f	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091264 application number: ANDA091264

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-551	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-551	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-1430	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-1430	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	A-S Medication Solutions	ANDA	Current
70518-0931	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0931	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0931	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0789	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0789	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0789	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
72789-023	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-023	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-023	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-023	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-023	Levocetirizine Dihydrochloride	Levocetirizine Dihydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current