Quinapril

Product NDC: 69097-842
11-digit product format: 690970842
Labeler code: 69097
Product ID: 69097-842_56ce107f-65d9-4ec8-8859-6a256b27dc57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quinapril
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA078457
Marketing category: ANDA
Marketing start: 2016-07-22
Substance: QUINAPRIL HYDROCHLORIDE
Active strength: 20 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 1.

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-10-29 15:01 UTC	2024-10	A078457-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078457-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078457-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078457-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	2007-08-24	`d06236e962d9…`

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	20 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312748	Internal RxNorm lookup
312749	Internal RxNorm lookup
312750	Internal RxNorm lookup
314203	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
e6d36e1e-8e35-4d06-83dc-45e0456365fd	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	Strength	SPL version
69097-842-05	Quinapril	90 in 1 BOTTLE	TABLET	90		5
69097-842-15	Quinapril	1000 in 1 BOTTLE	TABLET	1000		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-842	QUINAPRIL TABLET [CIPLA USA INC.]	5	Current NDC, Legacy NDC, 2 package rows	20230121_e6d36e1e-8e35-4d06-83dc-45e0456365fd.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 ndc (product): 69097-842
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

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	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
312749	quinapril HCl 20 MG Oral Tablet	PSN	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
314203	quinapril HCl 40 MG Oral Tablet	PSN	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
312750	quinapril HCl 5 MG Oral Tablet	PSN	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
312748	quinapril 10 MG Oral Tablet	SCD	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
312749	quinapril 20 MG Oral Tablet	SCD	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
314203	quinapril 40 MG Oral Tablet	SCD	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
312750	quinapril 5 MG Oral Tablet	SCD	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
312748	quinapril (as quinapril HCl) 10 MG Oral Tablet	SY	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
312749	quinapril (as quinapril HCl) 20 MG Oral Tablet	SY	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
314203	quinapril (as quinapril hydrochloride) 40 MG Oral Tablet	SY	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5
312750	quinapril (as quinapril hydrochloride) 5 MG Oral Tablet	SY	e6d36e1e-8e35-4d06-83dc-45e0456365fd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-842-05	69097084205	90 TABLET in 1 BOTTLE (69097-842-05)	90 tablet	2016-07-22	0000-00-00	No	No	Current
69097-842-15	69097084215	1000 TABLET in 1 BOTTLE (69097-842-15)	1000 tablet	2016-07-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quinapril Tablets, USP Rx Only	Cipla USA Inc. \| InvaGen Pharmaceutical Inc	2023-01-19	HUMAN PRESCRIPTION DRUG LABEL	5