Quinapril Hydrochloride/Hydrochlorothiazide

Product NDC: 35356-998
11-digit product format: 353560998
Labeler code: 35356
Product ID: 35356-998_72504531-8f26-4e25-bc63-2e705c9c41fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quinapril Hydrochloride/Hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: ANDA078450
Marketing category: ANDA
Marketing start: 2007-08-24
Marketing end: 0000-00-00
Substance: QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength: 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: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35356-998		D	Discontinued by firm	2026-10-05
excluded package	package	35356-998	35356-998-30	D	Discontinued by firm	2026-10-05
excluded package	package	35356-998	35356-998-60	D	Discontinued by firm	2026-10-05
excluded package	package	35356-998	35356-998-90	D	Discontinued by firm	2026-10-05

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 2 · 76 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-998-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-998-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-998-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-998-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-998-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-998-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-998-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-998-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-998-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-998-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-998-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-998-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-998-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-998-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-998-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-998-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-998-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-998-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-998-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-998-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-998-30	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-998-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-998-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-998-30	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-998-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-998-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-998-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-998-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-998-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-998-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-998-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-998-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-998-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-998-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-998-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-998-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	35356-998-90	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	35356-998-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	35356-998-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	35356-998-90	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	35356-998-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	35356-998-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	35356-998-90	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	35356-998-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	35356-998-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24
A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24
A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078450-001	AB
A078450-002	AB
A078450-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078450-002	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 20MG BASE	TABLET / ORAL	AB		2007-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078450-003	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	25MG;EQ 20MG BASE	TABLET / ORAL	AB	RS	2007-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078450-001	QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	12.5MG;EQ 10MG BASE	TABLET / ORAL	AB		2007-08-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078450-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078450-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078450-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078450-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078450-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078450-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078450-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078450-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078450-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078450-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078450-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078450-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078450-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078450-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078450-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078450-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078450-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078450-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078450-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078450-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078450-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078450-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078450-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078450-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078450-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078450-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078450-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078450-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078450-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078450-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078450-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078450-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078450-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078450-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078450-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078450-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078450-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078450-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078450-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078450-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
35356-998-30	2025-01-15	Quinapril Hydrochloride/Hydrochlorothiazide Tablets
35356-998-60	2025-01-15	Quinapril Hydrochloride/Hydrochlorothiazide Tablets
35356-998-90	2025-01-15	Quinapril Hydrochloride/Hydrochlorothiazide Tablets
35356-998-30	2021-01-29	Quinapril Hydrochloride/Hydrochlorothiazide Tablets
35356-998-60	2021-01-29	Quinapril Hydrochloride/Hydrochlorothiazide Tablets
35356-998-90	2021-01-29	Quinapril Hydrochloride/Hydrochlorothiazide Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-998-30	EA - Each	35356-998	f842f24f-7b0f-4cff-821f-0d0d3dbb08c4	1	2013-11-04
35356-998-60	EA - Each	35356-998	42703759-8744-4a39-84c7-335876a2834a	1	2013-11-04
35356-998-90	EA - Each	35356-998	97256445-0db2-4c32-a9ad-593571085676	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
QUINAPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	33067B3N2M	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
QUINAPRILAT	ACTIVE MOIETY	34SSX5LDE5	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE	Aurobindo Pharma Limited	50a58159-9572-4445-9859-b392632597da	2024-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078450 application number: ANDA078450

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33067B3N2M	QUINAPRIL HYDROCHLORIDE	82586-55-8	QUINAPRIL HYDROCHLORIDE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quinapril Hydrochloride/Hydrochlorothiazide Tablets	Lake Erie Medical DBA Quality Care Products LLC	2018-04-11	Human Prescription Drug Label	2