Quinapril

Product NDC
63629-7934
11-digit product format
636297934
Labeler code
63629
Product ID
63629-7934_03c7c1b9-9bf2-432b-8ed4-31df80eb340e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quinapril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202725
Marketing category
ANDA
Marketing start
2013-04-29
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
2026-12-31
Current FDA listing
Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63629-7934-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7934-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7934-11332a3947898…d4bfe170f9cd…

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
A202725-001QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-29
A202725-002QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-29
A202725-003QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-29
A202725-004QUINAPRIL HYDROCHLORIDEQUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202725-001AB
A202725-002AB
A202725-003AB
A202725-004AB

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 06:07:402026-07A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202725-001QUINAPRIL HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2013-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202725-002QUINAPRIL HYDROCHLORIDEEQ 10MG BASETABLET / ORALAB2013-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202725-003QUINAPRIL HYDROCHLORIDEEQ 20MG BASETABLET / ORALAB2013-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202725-004QUINAPRIL HYDROCHLORIDEEQ 40MG BASETABLET / ORALAB2013-04-29d8e5a09893c0…

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 06:07:402026-07A202725-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202725-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202725-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202725-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202725-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202725-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202725-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202725-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202725-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202725-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202725-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202725-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202725-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202725-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202725-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202725-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202725-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202725-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202725-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202725-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202725-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202725-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202725-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202725-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202725-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202725-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202725-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202725-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202725-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202725-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202725-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202725-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202725-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202725-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202725-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202725-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202725-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202725-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202725-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202725-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUINAPRIL HYDROCHLORIDE10 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
312748Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a62d0ed3-8fcc-45fb-9246-b57b08a11f60Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7934-12024-05-31C16284748780-11030e365-249a-111a-e063-dadaa90a10e2Quinapril Tablets, USP Rx only
63629-7934-12024-01-30C16284748780-11030e365-249a-111a-e063-dadaa90a10e2Quinapril Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7934-1Quinapril30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7934QUINAPRIL (QUINAPRIL HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 1 package rows20240602_a62d0ed3-8fcc-45fb-9246-b57b08a11f60.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuinaprilQUINAPRIL HYDROCHLORIDEBryant Ranch Prepacka62d0ed3-8fcc-45fb-9246-b57b08a11f602024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202725
application number: ANDA202725
ndc (product): 63629-7934
QuinaprilQUINAPRIL HYDROCHLORIDEAurobindo Pharma Limited93e6e668-5306-4f26-81d8-cbc3a7a5e7872024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202725
application number: ANDA202725
QuinaprilQUINAPRIL HYDROCHLORIDEProficient Rx LP42e4f9dd-6032-4257-bd0f-8e9b71027f032020-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202725
application number: ANDA202725

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312748quinapril HCl 10 MG Oral TabletPSNa62d0ed3-8fcc-45fb-9246-b57b08a11f603
312748quinapril 10 MG Oral TabletSCDa62d0ed3-8fcc-45fb-9246-b57b08a11f603
312748quinapril (as quinapril HCl) 10 MG Oral TabletSYa62d0ed3-8fcc-45fb-9246-b57b08a11f603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7934-16362979340130 TABLET, FILM COATED in 1 BOTTLE (63629-7934-1) 2019-03-010000-00-00NoNoCurrent