Quinapril

Product NDC
68084-899
Requested package NDC
68084-899-25
11-digit product format
680840899
Labeler code
68084
Product ID
68084-899_ea3fb07f-0005-8a55-e053-2a95a90a8243
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinapril
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077690
Marketing category
ANDA
Marketing start
2015-09-24
Marketing end
0000-00-00
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68084-89968084-899-25DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077690-001QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-20
A077690-002QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-20
A077690-003QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-20
A077690-004QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077690-001AB
A077690-002AB
A077690-003AB
A077690-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077690-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2006-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077690-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2006-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077690-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2006-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077690-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALABRS2006-06-20d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077690-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077690-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077690-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077690-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077690-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077690-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077690-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077690-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077690-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077690-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077690-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077690-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077690-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077690-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077690-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077690-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077690-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077690-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077690-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077690-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077690-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077690-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077690-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077690-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077690-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077690-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077690-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077690-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077690-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077690-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077690-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077690-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077690-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077690-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077690-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077690-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077690-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077690-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077690-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077690-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-899-25EA - Each68084-899ba3d7ce6-d69f-4233-8d9a-450b27efc31c12015-11-12
68084-899-95EA - Each68084-8993a5c929e-736c-4ca6-99dd-4ecbbfe55c8612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUINAPRIL HYDROCHLORIDEACTIVE INGREDIENT33067B3N2MQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
QUINAPRILATACTIVE MOIETY34SSX5LDE5QUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62QUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990QUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
TALCINACTIVE INGREDIENT7SEV7J4R1UQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEQUINAPRIL TABLET [AMERICAN HEALTH PACKAGING]1

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuinaprilQUINAPRILNorthwind Health Company, LLCda562e3b-4411-e750-e053-2a95a90ad7e52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077690
application number: ANDA077690
QuinaprilQUINAPRILBryant Ranch Prepacka6cf2ffd-cf94-4f1c-a12e-ce0e93a6304d2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077690
application number: ANDA077690
QuinaprilQUINAPRILLupin Pharmaceuticals, Inc.8ded0773-3aec-4e89-9836-d22a5a84abf02023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077690
application number: ANDA077690
QuinaprilQUINAPRILProficient Rx LP2efb2ede-a49b-4e3e-9c93-4c202f67211f2022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077690
application number: ANDA077690
QuinaprilQUINAPRILBluePoint Laboratories1b5809a8-873d-44cb-af59-e0d8fc81b3852020-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077690
application number: ANDA077690

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-899-256808408992530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-899-25) > 1 TABLET in 1 BLISTER PACK (68084-899-95) 30 blister pack2015-09-240000-00-00NoNoCurrent