ACCURETIC

Product NDC
0071-3112
Requested package NDC
0071-3112-23
11-digit product format
000713112
Labeler code
0071
Product ID
0071-3112_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
2021-11-29
Marketing end
0000-00-00
Substance
QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength
10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0071-31120071-3112-23DDiscontinued by firm2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020125-001ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28
N020125-002ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28
N020125-003ACCURETICHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020125-002ACCURETIC12.5MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020125-003ACCURETIC25MG;EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020125-001ACCURETIC12.5MG;EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-12-288072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020125-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020125-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020125-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020125-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020125-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020125-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020125-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020125-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020125-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020125-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020125-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020125-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020125-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020125-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020125-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020125-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020125-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020125-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020125-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020125-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020125-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020125-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020125-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020125-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020125-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020125-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020125-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020125-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020125-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020125-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020125-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020125-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020125-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020125-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020125-003AB1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020125-001AB13a93d1ddd44b…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0071-3112-23EA - Each0071-3112cff48af8-3daf-4174-b5e0-f51559437cca12021-12-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
QUINAPRIL HYDROCHLORIDEACTIVE INGREDIENT33067B3N2MACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
QUINAPRILATACTIVE MOIETY34SSX5LDE5ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
CROSPOVIDONEINACTIVE INGREDIENT68401960MKACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
POVIDONESINACTIVE INGREDIENTFZ989GH94EACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0071-3112ACCURETIC (QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED ACCURETIC (QUINAPRIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]32Legacy NDC20230919_80e9d61d-9674-4ac4-b84c-79a875d408dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0071-3112-230007131122390 TABLET, FILM COATED in 1 BOTTLE (0071-3112-23) 2021-11-290000-00-00NoNoCurrent