ACCURETIC

Product NDC: 0071-5212
11-digit product format: 000715212
Labeler code: 0071
Product ID: 0071-5212_1d3fab62-2114-4d5b-b07a-9b0f2b5a3efd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: quinapril and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Parke-Davis Div of Pfizer Inc
Application: NDA020125
Marketing category: NDA
Marketing start: 2021-12-06
Marketing end: 0000-00-00
Substance: QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength: 20 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: 2022-12-31
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	0071-5212		D	Discontinued by firm		2026-10-15
excluded package	package	0071-5212	0071-5212-23	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N020125-001	ACCURETIC	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28
N020125-002	ACCURETIC	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28
N020125-003	ACCURETIC	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020125-002	ACCURETIC	12.5MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020125-003	ACCURETIC	25MG;EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020125-001	ACCURETIC	12.5MG;EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-12-28	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020125-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020125-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020125-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020125-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020125-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020125-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020125-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020125-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020125-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020125-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020125-003	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0071-5212-23	EA - Each	0071-5212	abd81055-99e7-4c7b-9972-96158342f278	1	2021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
QUINAPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	33067B3N2M	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
QUINAPRILAT	ACTIVE MOIETY	34SSX5LDE5	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0071-5212	ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED ACCURETIC (QUINAPRIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]	32	Legacy NDC	20230919_80e9d61d-9674-4ac4-b84c-79a875d408dd.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0071-5212-23	00071521223	90 TABLET, FILM COATED in 1 BOTTLE (0071-5212-23)	2021-12-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACCURETIC™ (quinapril and hydrochlorothiazide) Tablets	Parke-Davis Div of Pfizer Inc \| Pfizer Manufacturing Deutschland GmbH	2023-09-18	HUMAN PRESCRIPTION DRUG LABEL	32