Accupril

Product NDC: 0071-0535
11-digit product format: 000710535
Labeler code: 0071
Product ID: 0071-0535_140c689b-e8c8-4db9-9bcf-c68869e0d762
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quinapril hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Parke-Davis Div of Pfizer Inc
Application: NDA019885
Marketing category: NDA
Marketing start: 1991-11-19
Marketing end: 0000-00-00
Substance: QUINAPRIL HYDROCHLORIDE
Active strength: 40 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0071-0535		D	Discontinued by firm		2026-08-17
excluded package	package	0071-0535	0071-0535-23	D	Discontinued by firm		2026-08-17

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	RLD / RS	Approval date
N019885-001	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19
N019885-002	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19
N019885-003	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19
N019885-004	ACCUPRIL	QUINAPRIL HYDROCHLORIDE	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019885-001	ACCUPRIL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019885-002	ACCUPRIL	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019885-003	ACCUPRIL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019885-004	ACCUPRIL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-11-19	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	N019885-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019885-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019885-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019885-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019885-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019885-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019885-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019885-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019885-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019885-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019885-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019885-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019885-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019885-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019885-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019885-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019885-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019885-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019885-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019885-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019885-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019885-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019885-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019885-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019885-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019885-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019885-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019885-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019885-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019885-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019885-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019885-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019885-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019885-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019885-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019885-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019885-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019885-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019885-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019885-004	AB	1	`c0c555d07b60…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0071-0535-23	EA - Each	0071-0535	6d277627-a267-42c0-b268-73c0f2fafdc3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUINAPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	33067B3N2M	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
QUINAPRILAT	ACTIVE MOIETY	34SSX5LDE5	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0071-0535	ACCUPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED ACCUPRIL (QUINAPRIL) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	26	Legacy NDC	20250119_63cf5651-d52c-4d27-9fd4-ed9cd9724dff.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0071-0535-23	00071053523	90 TABLET, FILM COATED in 1 BOTTLE (0071-0535-23)	1991-11-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Accupril ® (quinapril) Tablets	Parke-Davis Div of Pfizer Inc \| Pfizer Inc	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	26