QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE

Product NDC: 65862-162
Requested package NDC: 65862-162-59
11-digit product format: 658620162
Labeler code: 65862
Product ID: 65862-162_5842ecc2-874a-481b-8997-afa9d862dc5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078450
Marketing category: ANDA
Marketing start: 2007-08-24
Substance: QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength: 20; 12.5 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-162	65862-162-59	UNFINISHED	Active or certified unfinished drug listing		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 1 · 21 matching rows.

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

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

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.

Additional Listing Data#

Finished product: Yes
Brand name base: QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUINAPRIL HYDROCHLORIDE	20 mg/1
HYDROCHLOROTHIAZIDE	12.5 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
33067B3N2M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310796	Internal RxNorm lookup
310797	Internal RxNorm lookup
310809	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
50a58159-9572-4445-9859-b392632597da	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
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
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
9992a562-005f-c280-535c-2e4eaa81efcd	Product name	2	20161121
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
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
65862-162-30	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30		24
65862-162-90	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90		24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-162-30	EA - Each	65862-162	296d054b-6a12-4acc-a0a2-5ff9e0c3e250	1	2012-07-24
65862-162-90	EA - Each	65862-162	207bf9ed-d460-468f-8cd5-c34122ddcf05	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
QUINAPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	33067B3N2M	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
QUINAPRILAT	ACTIVE MOIETY	34SSX5LDE5	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	13
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-162	QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	24	Current NDC, Legacy NDC, 2 package rows	20240430_50a58159-9572-4445-9859-b392632597da.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 · 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 ndc (product): 65862-162

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310796	quinapril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	50a58159-9572-4445-9859-b392632597da	24
310797	quinapril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	50a58159-9572-4445-9859-b392632597da	24
310809	quinapril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	50a58159-9572-4445-9859-b392632597da	24
310796	hydrochlorothiazide 12.5 MG / quinapril 10 MG Oral Tablet	SCD	50a58159-9572-4445-9859-b392632597da	24
310797	hydrochlorothiazide 12.5 MG / quinapril 20 MG Oral Tablet	SCD	50a58159-9572-4445-9859-b392632597da	24
310809	hydrochlorothiazide 25 MG / quinapril 20 MG Oral Tablet	SCD	50a58159-9572-4445-9859-b392632597da	24
310796	HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 10 MG Oral Tablet	SY	50a58159-9572-4445-9859-b392632597da	24
310797	HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 20 MG Oral Tablet	SY	50a58159-9572-4445-9859-b392632597da	24
310796	HCTZ 12.5 MG / quinapril 10 MG Oral Tablet	SY	50a58159-9572-4445-9859-b392632597da	24
310797	HCTZ 12.5 MG / quinapril 20 MG Oral Tablet	SY	50a58159-9572-4445-9859-b392632597da	24
310809	HCTZ 25 MG / quinapril (as quinapril hydrochloride) 20 MG Oral Tablet	SY	50a58159-9572-4445-9859-b392632597da	24
310809	HCTZ 25 MG / quinapril 20 MG Oral Tablet	SY	50a58159-9572-4445-9859-b392632597da	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-162-59	65862016259	5000 TABLET, FILM COATED in 1 BAG (65862-162-59)	24-AUG-07	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quinapril and Hydrochlorothiazide Tablets, USP Rx only	Aurobindo Pharma Limited	2024-04-28	Human Prescription Drug Label	24
Quinapril Hydrochloride/Hydrochlorothiazide Tablets	Lake Erie Medical DBA Quality Care Products LLC	2018-04-11	Human Prescription Drug Label	2