Lisinopril and Hydrochlorothiazide

Product NDC: 0591-0862
11-digit product format: 005910862
Labeler code: 0591
Product ID: 0591-0862_ab203e31-9939-4e72-8ccd-ed55261bfb65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lisinopril and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA076194
Marketing category: ANDA
Marketing start: 2003-03-04
Substance: HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength: 25; 20 mg/1; mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	0591-0862		UNFINISHED	Active or certified unfinished drug listing		2026-08-03
unfinished package	package	0591-0862	0591-0862-00	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0591-0862-00	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0591-0862-00	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-0862-00	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-0862-00	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-0862-00	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-0862-00	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-0862-00	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-0862-00	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-0862-00	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-0862-00	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0591-0862-00	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0591-0862-00	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0591-0862-00	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0591-0862-00	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0591-0862-00	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0591-0862-00	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0591-0862-00	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0591-0862-00	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0591-0862-00	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0591-0862-00	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0591-0862-00	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A076194-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01
A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG	TABLET / ORAL	AB	2002-07-01
A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG	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
A076194-001	AB
A076194-002	AB
A076194-003	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	A076194-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076194-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076194-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076194-001	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	A076194-002	LISINOPRIL AND HYDROCHLOROTHIAZIDE	25MG;20MG	TABLET / ORAL	AB	2002-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076194-003	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;10MG	TABLET / ORAL	AB	2002-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076194-001	LISINOPRIL AND HYDROCHLOROTHIAZIDE	12.5MG;20MG	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	A076194-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076194-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076194-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076194-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076194-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076194-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076194-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076194-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076194-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076194-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076194-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076194-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076194-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076194-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076194-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076194-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076194-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076194-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076194-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076194-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076194-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076194-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076194-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076194-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076194-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076194-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076194-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076194-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076194-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076194-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076194-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076194-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076194-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076194-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076194-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076194-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076194-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076194-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076194-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076194-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lisinopril and Hydrochlorothiazide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LISINOPRIL	25 mg/1
HYDROCHLOROTHIAZIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0J48LPH2TH	Internal UNII lookup
E7199S1YWR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197885	Internal RxNorm lookup
197886	Internal RxNorm lookup
197887	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
ab5e9ae4-e575-4a63-99f3-2bde36bdd508	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820	Product name	1	20230703
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
f65307a7-3644-0a09-cdfd-94aae8d3b53e	Product name	3	20210902
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-0862-01	Lisinopril and Hydrochlorothiazide	100 in 1 BOTTLE, PLASTIC	TABLET	100		29
0591-0862-05	Lisinopril and Hydrochlorothiazide	500 in 1 BOTTLE, PLASTIC	TABLET	500		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-0862-01	EA - Each	0591-0862	bbe624b9-cfc2-4207-88a6-58eb5f1caa44	1	2012-07-24
0591-0862-05	EA - Each	0591-0862	fd4dfa52-b0c5-4275-9528-68912b4a621b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
LISINOPRIL	ACTIVE INGREDIENT	E7199S1YWR	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
LISINOPRIL ANHYDROUS	ACTIVE MOIETY	7Q3P4BS2FD	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [WATSON LABORATORIES, INC.]	15
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
LISINOPRIL	ACTIVE INGREDIENT	E7199S1YWR	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
LISINOPRIL	ACTIVE INGREDIENT	E7199S1YWR	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
LISINOPRIL	ACTIVE MOIETY	E7199S1YWR	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
LISINOPRIL ANHYDROUS	ACTIVE MOIETY	7Q3P4BS2FD	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-0862	LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [ACTAVIS PHARMA, INC.]	28	Current NDC, Legacy NDC, 2 package rows	20220922_ab5e9ae4-e575-4a63-99f3-2bde36bdd508.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Northwind Health Company, LLC	3d801e51-e675-45eb-bc7e-407e610f4009	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076194 application number: ANDA076194
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	QPharma Inc	ff7b2d81-9006-465d-9095-1bd8696a12a6	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076194 application number: ANDA076194
Lisinopril and hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	NuCarePharmaceuticals, Inc.	4fbf31a1-037b-31a2-e054-00144ff88e88	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076194 application number: ANDA076194
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	NuCare Pharmaceuticals,Inc.	6c57bf12-9ad5-3a25-e053-2a91aa0aaf26	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076194 application number: ANDA076194
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	2b66693d-0514-4f41-b405-bd3dd7618e81	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076194 application number: ANDA076194
Lisinopril and hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Proficient Rx LP	af0b3bef-be36-432a-884e-ea81e2d5c08e	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076194 application number: ANDA076194
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Actavis Pharma, Inc.	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	2020-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076194 application number: ANDA076194 ndc (product): 0591-0862
Lisinopril and Hydrochlorothiazide	LISINOPRIL AND HYDROCHLOROTHIAZIDE	Aphena Pharma Solutions - Tennessee, LLC	5eea66bd-589a-45f8-ba2c-dea66a939d59	2019-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076194 application number: ANDA076194

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
E7199S1YWR	LISINOPRIL	83915-83-7	LISINOPRIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197887	lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	03416554-c787-4bea-902f-41d94629cd64	100
197887	hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet	SCD	03416554-c787-4bea-902f-41d94629cd64	100
197887	HCTZ 25 MG / lisinopril 20 MG Oral Tablet	SY	03416554-c787-4bea-902f-41d94629cd64	100
197885	lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197886	lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197887	lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197885	hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral Tablet	SCD	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197886	hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet	SCD	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197887	hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet	SCD	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197885	HCTZ 12.5 MG / lisinopril 10 MG Oral Tablet	SY	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197886	HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet	SY	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197887	HCTZ 25 MG / lisinopril 20 MG Oral Tablet	SY	ab5e9ae4-e575-4a63-99f3-2bde36bdd508	29
197886	lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	af0b3bef-be36-432a-884e-ea81e2d5c08e	6
197887	lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	af0b3bef-be36-432a-884e-ea81e2d5c08e	6
197886	hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet	SCD	af0b3bef-be36-432a-884e-ea81e2d5c08e	6
197887	hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet	SCD	af0b3bef-be36-432a-884e-ea81e2d5c08e	6
197886	HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet	SY	af0b3bef-be36-432a-884e-ea81e2d5c08e	6
197887	HCTZ 25 MG / lisinopril 20 MG Oral Tablet	SY	af0b3bef-be36-432a-884e-ea81e2d5c08e	6
197885	lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	63fa5147-fb3e-47ec-bea1-a80e1f551866	1
197886	lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	63fa5147-fb3e-47ec-bea1-a80e1f551866	1
197887	lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	63fa5147-fb3e-47ec-bea1-a80e1f551866	1
197885	hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral Tablet	SCD	63fa5147-fb3e-47ec-bea1-a80e1f551866	1
197886	hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet	SCD	63fa5147-fb3e-47ec-bea1-a80e1f551866	1
197887	hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet	SCD	63fa5147-fb3e-47ec-bea1-a80e1f551866	1
197885	HCTZ 12.5 MG / lisinopril 10 MG Oral Tablet	SY	63fa5147-fb3e-47ec-bea1-a80e1f551866	1
197886	HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet	SY	63fa5147-fb3e-47ec-bea1-a80e1f551866	1
197887	HCTZ 25 MG / lisinopril 20 MG Oral Tablet	SY	63fa5147-fb3e-47ec-bea1-a80e1f551866	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-0862-00	00591086200	25000 TABLET in 1 BAG (0591-0862-00)	25000 tablet	01-MAR-03				Current
0591-0862-01	00591086201	100 TABLET in 1 BOTTLE, PLASTIC (0591-0862-01)	100 tablet	2003-03-04	0000-00-00	No	No	Current
0591-0862-05	00591086205	500 TABLET in 1 BOTTLE, PLASTIC (0591-0862-05)	500 tablet	2003-03-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	23
Lisinopril and Hydrochlorothiazide Tablets Revised: January 2013 Rx only	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	6
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP	Preferred Pharmaceuticals Inc.	2022-03-17	HUMAN PRESCRIPTION DRUG LABEL	1
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL	100
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP Rx Only	NuCare Pharmaceuticals,Inc.	2021-02-19	HUMAN PRESCRIPTION DRUG LABEL	2
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP Rx Only	Quality Care Products, LLC	2020-08-25	HUMAN PRESCRIPTION DRUG LABEL	2
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP	Actavis Pharma, Inc.	2020-05-01	HUMAN PRESCRIPTION DRUG LABEL	29
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-04-15	HUMAN PRESCRIPTION DRUG LABEL	1
Lisinopril and Hydrochlorothiazide Tablets Revised: March 2009 Rx only 184007	Rebel Distributors Corp	2010-10-01	HUMAN PRESCRIPTION DRUG LABEL	1