Quinapril

Product NDC: 63187-425
11-digit product format: 631870425
Labeler code: 63187
Product ID: 63187-425_b91e5277-f38e-47fd-9733-bab3dfdfb3d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quinapril
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078457
Marketing category: ANDA
Marketing start: 2012-01-20
Substance: QUINAPRIL HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078457-001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24
A078457-002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24
A078457-003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24
A078457-004	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078457-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078457-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078457-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078457-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078457-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078457-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078457-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078457-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078457-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078457-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078457-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078457-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078457-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078457-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078457-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078457-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078457-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078457-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078457-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078457-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078457-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078457-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078457-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078457-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078457-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078457-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078457-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078457-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078457-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078457-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078457-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078457-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078457-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078457-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078457-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078457-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078457-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078457-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078457-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078457-004	AB	1	`c0c555d07b60…`

Additional Listing Data#

Finished product: Yes
Brand name base: Quinapril
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUINAPRIL HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33067B3N2M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312748	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
f33dbbb1-1a4a-42b0-a5c5-3ac905823206	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9992a562-005f-c280-535c-2e4eaa81efcd	Product name	2	20161121
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-425-30	Quinapril	30 in 1 BOTTLE	TABLET	30	4
63187-425-60	Quinapril	60 in 1 BOTTLE	TABLET	60	4
63187-425-90	Quinapril	90 in 1 BOTTLE	TABLET	90	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUINAPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	33067B3N2M	QUINAPRIL TABLET [PROFICIENT RX LP]	1
QUINAPRILAT	ACTIVE MOIETY	34SSX5LDE5	QUINAPRIL TABLET [PROFICIENT RX LP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	QUINAPRIL TABLET [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	QUINAPRIL TABLET [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	QUINAPRIL TABLET [PROFICIENT RX LP]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	QUINAPRIL TABLET [PROFICIENT RX LP]	1
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	QUINAPRIL TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUINAPRIL TABLET [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	QUINAPRIL TABLET [PROFICIENT RX LP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	QUINAPRIL TABLET [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUINAPRIL TABLET [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-425	QUINAPRIL TABLET [PROFICIENT RX LP]	4	Current NDC, Legacy NDC, 3 package rows	20210115_f33dbbb1-1a4a-42b0-a5c5-3ac905823206.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quinapril	QUINAPRIL	Cipla USA Inc.	e6d36e1e-8e35-4d06-83dc-45e0456365fd	2023-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078457 application number: ANDA078457
Quinapril	QUINAPRIL	Proficient Rx LP	f33dbbb1-1a4a-42b0-a5c5-3ac905823206	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078457 application number: ANDA078457 ndc (product): 63187-425

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33067B3N2M	QUINAPRIL HYDROCHLORIDE	82586-55-8	QUINAPRIL HYDROCHLORIDE
RJ84Y44811	QUINAPRIL	85441-61-8	Quinapril

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312748	quinapril HCl 10 MG Oral Tablet	PSN	f33dbbb1-1a4a-42b0-a5c5-3ac905823206	4
312748	quinapril 10 MG Oral Tablet	SCD	f33dbbb1-1a4a-42b0-a5c5-3ac905823206	4
312748	quinapril (as quinapril HCl) 10 MG Oral Tablet	SY	f33dbbb1-1a4a-42b0-a5c5-3ac905823206	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-425-30	63187042530	30 TABLET in 1 BOTTLE (63187-425-30)	30 tablet	2015-02-02	0000-00-00	No	No	Current
63187-425-60	63187042560	60 TABLET in 1 BOTTLE (63187-425-60)	60 tablet	2015-02-02	0000-00-00	No	No	Current
63187-425-90	63187042590	90 TABLET in 1 BOTTLE (63187-425-90)	90 tablet	2015-02-02	0000-00-00	No	No	Current