FDA.reportPublic FDA data

Quinapril and Hydrochlorothiazide 10/12.5

Product NDC
69097-828
11-digit product format
690970828
Labeler code
69097
Product ID
69097-828_4d3f7e7a-ed61-4df6-bc45-f38fb4117406
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quinapril and Hydrochlorothiazide 10/12.5
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA201356
Marketing category
ANDA
Marketing start
2016-07-20
Substance
QUINAPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Active strength
10; 12.5 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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-20
A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-20
A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-20

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-2084e616aacf4f…
2026-09-14 22:38:342026-08A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-2084e616aacf4f…
2026-09-14 22:38:342026-08A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-2084e616aacf4f…
2026-08-18 06:07:402026-07A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-20caaa826d4ba7…
2026-08-18 06:07:402026-07A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-20caaa826d4ba7…
2026-08-18 06:07:402026-07A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201356-002QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 20MG BASETABLET / ORAL2011-04-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201356-003QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;EQ 20MG BASETABLET / ORAL2011-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201356-001QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;EQ 10MG BASETABLET / ORAL2011-04-20301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201356-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201356-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201356-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201356-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201356-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201356-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201356-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201356-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201356-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201356-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201356-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201356-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201356-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201356-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201356-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201356-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201356-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201356-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201356-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201356-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201356-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A201356-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A201356-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A201356-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201356-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A201356-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A201356-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201356-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A201356-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A201356-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201356-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A201356-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A201356-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A201356-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201356-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201356-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201356-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201356-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201356-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201356-001AB16a51e52b5d6a…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Quinapril and Hydrochlorothiazide 10/12.5
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUINAPRIL HYDROCHLORIDE10 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup
33067B3N2MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310796Internal RxNorm lookup
310797Internal RxNorm lookup
310809Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1de5420c-23d6-40c5-ba24-39143c0f90fbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
9992a562-005f-c280-535c-2e4eaa81efcdProduct name220161121
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-828-05Quinapril and Hydrochlorothiazide 10/12.590 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-828QUINAPRIL AND HYDROCHLOROTHIAZIDE 10/12.5 TABLET QUINAPRIL AND HYDROCHLOROTHIAZIDE 20/12.5 TABLET QUINAPRIL AND HYDROCHLOROTHIAZIDE 20/25 (QUINAPRIL AND HYDROCHLOROTHIAZIDE 20/25) TABLET [CIPLA USA INC.]4Current NDC, Legacy NDC, 1 package rows20220111_1de5420c-23d6-40c5-ba24-39143c0f90fb.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quinapril and Hydrochlorothiazide 10/12.5QUINAPRIL AND HYDROCHLOROTHIAZIDE 10/12.5Cipla USA Inc.1de5420c-23d6-40c5-ba24-39143c0f90fb2022-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201356
application number: ANDA201356
ndc (product): 69097-828

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310796quinapril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN1de5420c-23d6-40c5-ba24-39143c0f90fb4
310797quinapril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN1de5420c-23d6-40c5-ba24-39143c0f90fb4
310809quinapril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN1de5420c-23d6-40c5-ba24-39143c0f90fb4
310796hydrochlorothiazide 12.5 MG / quinapril 10 MG Oral TabletSCD1de5420c-23d6-40c5-ba24-39143c0f90fb4
310797hydrochlorothiazide 12.5 MG / quinapril 20 MG Oral TabletSCD1de5420c-23d6-40c5-ba24-39143c0f90fb4
310809hydrochlorothiazide 25 MG / quinapril 20 MG Oral TabletSCD1de5420c-23d6-40c5-ba24-39143c0f90fb4
310796HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 10 MG Oral TabletSY1de5420c-23d6-40c5-ba24-39143c0f90fb4
310797HCTZ 12.5 MG / quinapril (as quinapril hydrochloride) 20 MG Oral TabletSY1de5420c-23d6-40c5-ba24-39143c0f90fb4
310796HCTZ 12.5 MG / quinapril 10 MG Oral TabletSY1de5420c-23d6-40c5-ba24-39143c0f90fb4
310797HCTZ 12.5 MG / quinapril 20 MG Oral TabletSY1de5420c-23d6-40c5-ba24-39143c0f90fb4
310809HCTZ 25 MG / quinapril (as quinapril hydrochloride) 20 MG Oral TabletSY1de5420c-23d6-40c5-ba24-39143c0f90fb4
310809HCTZ 25 MG / quinapril 20 MG Oral TabletSY1de5420c-23d6-40c5-ba24-39143c0f90fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-828-056909708280590 TABLET in 1 BOTTLE (69097-828-05) 90 tablet2016-07-200000-00-00NoNoCurrent