QUINAPRIL

Product NDC
50090-5400
11-digit product format
500905400
Labeler code
50090
Product ID
50090-5400_ef15db5c-724f-4af0-98bb-2925ca172b0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quinapril
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205823
Marketing category
ANDA
Marketing start
2017-11-10
Marketing end
0000-00-00
Substance
QUINAPRIL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5400DDiscontinued by firm2026-08-17
excluded packagepackage50090-540050090-5400-0DDiscontinued by firm2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5400-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5400-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-5400-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-5400-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-5400-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-5400-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-5400-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-5400-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-5400-00efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205823-001QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-15
A205823-002QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-15
A205823-003QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-15
A205823-004QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205823-001AB
A205823-002AB
A205823-003AB
A205823-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-15caaa826d4ba7…
2026-08-18 06:07:402026-07A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-15d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205823-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205823-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205823-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205823-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205823-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205823-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205823-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205823-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205823-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205823-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205823-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205823-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205823-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205823-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205823-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205823-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205823-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205823-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205823-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205823-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205823-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205823-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205823-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205823-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205823-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205823-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205823-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205823-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205823-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205823-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205823-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205823-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205823-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205823-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205823-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205823-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205823-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205823-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205823-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205823-004AB1d8e5a09893c0…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5400-02023-02-06C16284748780-1f386c64a-033e-0266-e053-dadaa90a7c1aQuinapril Tablets, USP
50090-5400-02023-01-30C16284748780-1f386c64a-033e-0266-e053-dadaa90a7c1aQuinapril Tablets, USP

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUINAPRILQUINAPRILBryant Ranch Prepackfb069caa-14d0-4f76-b662-6145fb4cc2762023-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205823
application number: ANDA205823
QUINAPRILQUINAPRILProficient Rx LP1aafcf35-46cb-4a6f-81d4-821c599bdb712022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205823
application number: ANDA205823
QUINAPRILQUINAPRILBryant Ranch Prepackda84cb14-a9dd-4df0-a7e5-d5fbd84ac6da2021-08-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205823
application number: ANDA205823
QUINAPRILQUINAPRILSolco Healthcare US, LLCcd46691d-5593-4a9f-a937-999c6803e3122020-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205823
application number: ANDA205823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5400-05009054000030 TABLET in 1 BOTTLE (50090-5400-0) 30 tablet2020-12-070000-00-00NoNoCurrent