QUINAPRIL

Product NDC
63629-8710
11-digit product format
636298710
Labeler code
63629
Product ID
63629-8710_78872c13-1caa-4a0f-9f5e-995fcfb35e73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quinapril
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205823
Marketing category
ANDA
Marketing start
2017-11-10
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
2026-12-31
Current FDA listing
Yes

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
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 · 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 UTC2026-02A205823-001QUINAPRIL 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…
2024-10-29 15:01 UTC2024-10A205823-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2016-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A205823-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2016-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A205823-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2016-09-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A205823-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2016-09-15d06236e962d9…

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 UTC2026-02A205823-001AB1011fe1cb6892…
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…
2024-10-29 15:01 UTC2024-10A205823-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205823-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205823-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205823-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
QUINAPRIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUINAPRIL HYDROCHLORIDE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33067B3N2MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312749Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
da84cb14-a9dd-4df0-a7e5-d5fbd84ac6daAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9992a562-005f-c280-535c-2e4eaa81efcdProduct name220161121
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8710-1QUINAPRIL30 in 1 BOTTLETABLET30100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8710QUINAPRIL TABLET [BRYANT RANCH PREPACK]100Current NDC, Legacy NDC, 1 package rows20210821_da84cb14-a9dd-4df0-a7e5-d5fbd84ac6da.zip

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
ndc (product): 63629-8710
QUINAPRILQUINAPRILSolco Healthcare US, LLCcd46691d-5593-4a9f-a937-999c6803e3122020-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205823
application number: ANDA205823

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312749quinapril HCl 20 MG Oral TabletPSNda84cb14-a9dd-4df0-a7e5-d5fbd84ac6da100
312749quinapril 20 MG Oral TabletSCDda84cb14-a9dd-4df0-a7e5-d5fbd84ac6da100
312749quinapril (as quinapril HCl) 20 MG Oral TabletSYda84cb14-a9dd-4df0-a7e5-d5fbd84ac6da100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8710-16362987100130 TABLET in 1 BOTTLE (63629-8710-1) 30 tablet2021-08-020000-00-00NoNoCurrent