Application 076007

Type: ANDA
Sponsor: SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	12.5MG;10MG	No	No
002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	12.5MG;20MG	No	No
003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	25MG;20MG	No	No

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	Approval date
A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01
A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01
A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET / ORAL	AB	2002-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076007-001	AB
A076007-002	AB
A076007-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076007-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076007-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076007-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`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	A076007-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076007-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076007-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076007-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076007-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076007-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076007-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076007-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076007-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076007-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076007-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076007-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076007-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076007-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076007-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076007-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076007-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076007-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076007-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076007-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076007-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076007-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076007-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076007-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076007-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076007-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076007-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076007-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076007-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076007-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076007-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076007-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076007-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076007-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076007-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076007-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076007-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076007-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076007-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076007-001	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 4 · 67 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	d7214539-6c3d-466a-a474-6fde096fa182	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	St. Mary's Medical Park Pharmacy	e1aa9682-b1ad-4a22-e053-2a95a90a0e2f	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	3857ac53-0435-4d68-8066-c22291414889	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	868b1442-c412-4ee8-9798-f2408cd2249a	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	408e797a-2cf3-4ee6-9f9b-179a8cf3d799	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	St. Mary's Medical Park Pharmacy	00b266d9-ac4a-e931-e063-6294a90a6a0b	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Coupler LLC	52b90789-2902-3ab9-e063-6394a90a5abb	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Preferred Pharmaceuticals Inc.	5956a107-0f7b-49e7-b9c9-36790349b06e	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Preferred Pharmaceuticals, Inc.	5aa18b0b-4688-493a-a5ae-cb056ea6c0e3	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Preferred Pharmaceuticals Inc.	9207c3bc-e12e-4017-8b85-0f928e744f64	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	Preferred Pharmaceuticals Inc.	fc4d7d0e-78a6-4d7e-ba53-aeeb008aa2dc	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	544b75eb-55f1-4164-9b83-39f6bc5fb479	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	REMEDYREPACK INC.	d383e0e5-4e00-44cc-9d6f-86e76f4e79e3	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	REMEDYREPACK INC.	3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e	2026-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	019ac336-0dc3-ec89-3e0a-09110e0fc30b	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	eac8c44f-cf77-6a30-cfd7-7cffffc79bd6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE	LISINOPRIL AND HYDROCHLOROTHIAZIDE	St Marys Medical Park Pharmacy	e7b68ea6-4fc8-441a-9640-1ccd3a482d8e	2026-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Legacy Pharmaceutical Packaging, LLC	6d729ec5-7311-4534-9999-9d6fa4f3ba2f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	A-S Medication Solutions	7d4ee5ec-5b68-453b-8d6e-214457a58159	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS	A-S Medication Solutions	62e8c093-cd8e-4342-aadb-209c7e6699c8	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Lisinopril and Hydrochlorothiazide

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-536	Lisinopril and Hydrochlorothiazide	Lisinopril and hydrochlorothiazide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-537	Lisinopril and Hydrochlorothiazide	Lisinopril and hydrochlorothiazide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-538	Lisinopril and Hydrochlorothiazide	Lisinopril and hydrochlorothiazide	Ranbaxy Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31060	ORIG	2004-06-08
8848	ORIG	2003-04-10