QUINAPRIL

Product NDC: 63629-8710
Requested package NDC: 63629-8710-1
11-digit product format: 636298710
Labeler code: 63629
Product ID: 63629-8710_78872c13-1caa-4a0f-9f5e-995fcfb35e73
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quinapril
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA205823
Marketing category: ANDA
Marketing start: 2017-11-10
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 43.

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	TE codes	Approval date
A205823-001	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15
A205823-002	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15
A205823-003	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15
A205823-004	QUINAPRIL HYDROCHLORIDE	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205823-001	AB
A205823-002	AB
A205823-003	AB
A205823-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-001	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-002	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-003	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-004	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2016-09-15	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A205823-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205823-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205823-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205823-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205823-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205823-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205823-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205823-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205823-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205823-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205823-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205823-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205823-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205823-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205823-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205823-004	AB	1	`5bbf6a4d5a75…`

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
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312749	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
da84cb14-a9dd-4df0-a7e5-d5fbd84ac6da	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
63629-8710-1	QUINAPRIL	30 in 1 BOTTLE	TABLET	30		100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8710	QUINAPRIL TABLET [BRYANT RANCH PREPACK]	100	Current NDC, Legacy NDC, 1 package rows	20210821_da84cb14-a9dd-4df0-a7e5-d5fbd84ac6da.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUINAPRIL	QUINAPRIL	Bryant Ranch Prepack	fb069caa-14d0-4f76-b662-6145fb4cc276	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205823 application number: ANDA205823
QUINAPRIL	QUINAPRIL	Proficient Rx LP	1aafcf35-46cb-4a6f-81d4-821c599bdb71	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205823 application number: ANDA205823
QUINAPRIL	QUINAPRIL	Bryant Ranch Prepack	da84cb14-a9dd-4df0-a7e5-d5fbd84ac6da	2021-08-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205823 application number: ANDA205823 ndc (package): 63629-8710-1 ndc (product): 63629-8710 ndc11 (package): 63629871001
QUINAPRIL	QUINAPRIL	Solco Healthcare US, LLC	cd46691d-5593-4a9f-a937-999c6803e312	2020-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205823 application number: ANDA205823

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
312749	quinapril HCl 20 MG Oral Tablet	PSN	da84cb14-a9dd-4df0-a7e5-d5fbd84ac6da	100
312749	quinapril 20 MG Oral Tablet	SCD	da84cb14-a9dd-4df0-a7e5-d5fbd84ac6da	100
312749	quinapril (as quinapril HCl) 20 MG Oral Tablet	SY	da84cb14-a9dd-4df0-a7e5-d5fbd84ac6da	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8710-1	63629871001	30 TABLET in 1 BOTTLE (63629-8710-1)	30 tablet	2021-08-02	0000-00-00	No	No	Current