Application 091629

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;50MG	No	No
002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;100MG	No	No
003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	25MG;100MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06
A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06
A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091629-001	AB
A091629-002	AB
A091629-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091629-002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;100MG	TABLET / ORAL	AB		2010-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091629-003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	25MG;100MG	TABLET / ORAL	AB	RS	2010-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091629-001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	12.5MG;50MG	TABLET / ORAL	AB		2010-10-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A091629-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091629-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091629-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091629-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091629-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091629-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091629-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091629-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091629-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091629-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091629-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091629-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091629-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091629-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091629-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091629-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091629-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091629-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091629-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091629-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091629-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091629-001	AB	1	`8072bd15b7f6…`

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
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	9f9cd7a7-be95-4ea8-8247-eb7ecbd36936	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629 ndc (product): 70518-2737
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	be99cc03-ea65-4b17-bd9e-df7ae4307778	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	dc9512cf-db66-40e9-afcb-1d6a722772e8	2026-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	5ec290f4-bf21-4c5b-a576-8eb2bd6bd379	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Coupler LLC	44fd38d2-cb8b-d0e8-e063-6294a90a994e	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	bc8b9ae2-8263-4624-8629-4f856392f9da	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	PD-Rx Pharmaceuticals, Inc.	dcb39c6b-430d-4b3d-ba6f-5bf1efe116aa	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	60f3f17d-fd28-406d-97ca-9f01f5f1c72c	2025-09-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	NorthStar Rx LLC	25318baf-9c2f-458f-b9ea-f52dabca49af	2025-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	dc177d6c-c754-4379-8c2f-1cf6f52f950a	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629 ndc (product): 65862-468 ndc (product): 65862-469 ndc (product): 65862-470
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals Inc.	24ee299f-4466-45d4-9013-17791e1998bb	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629 ndc (product): 68788-6452
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	DirectRx	cf4278a3-fbb7-a8ab-e053-2a95a90abc0f	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Direct_Rx	8de04bf2-83dd-c494-e053-2a95a90abade	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	A-S Medication Solutions	98b97680-474c-4e70-89dd-15bb49773125	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	a6e7d8a7-f969-4a21-ac28-93c77ed1fa63	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629
Losartan Potassium and Hydrochlorothiazide	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	198d5151-7982-4639-9fe1-6573a4529348	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091629 application number: ANDA091629

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 186 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63739-528	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-528	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	McKesson Corporation	ANDA	Current
63739-529	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-529	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	McKesson Corporation	ANDA	Current
65862-468	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-468	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-468	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-468	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-468	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-468	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-468	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-468	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-469	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-469	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-469	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-469	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-469	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-469	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-469	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-469	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-470	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-470	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-470	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-470	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-470	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-470	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-470	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
65862-470	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Aurobindo Pharma Limited	ANDA	Current
68071-1613	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1613	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1613	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1690	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1690	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1690	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1916	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1916	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1916	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1916	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1947	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1947	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1947	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1952	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-2177	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4448	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4448	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4448	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4448	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4493	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4493	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4640	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4640	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4699	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4699	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6329	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6329	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6329	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6329	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6329	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6452	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6452	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6452	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6452	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6452	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6812	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6812	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6812	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6812	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6812	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1682	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-1682	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2057	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2057	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2417	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2417	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2417	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2417	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2737	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2737	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
70518-2737	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	REMEDYREPACK INC.	ANDA	Current
71205-256	Losartan Potassium and Hydrochlorothiazide	Losartan Potassium and Hydrochlorothiazide	Proficient Rx LP	ANDA	Current