Home NDC 43386-710 Quinapril HCL and Hydrochlorothiazide
Product NDC 43386-710
11-digit product format 433860710
Labeler code 43386
Product ID 43386-710_916f3e69-0d6e-4524-8abe-afb2e134eec2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quinapril HCl and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA076374
Marketing category ANDA
Marketing start 2011-07-15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076374-001 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 A076374-002 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 A076374-003 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076374-002 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076374-003 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 25MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076374-001 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;EQ 10MG BASE TABLET / ORAL 2004-03-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076374-002 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076374-003 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 25MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076374-001 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;EQ 10MG BASE TABLET / ORAL 2004-03-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076374-002 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076374-003 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 25MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076374-001 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;EQ 10MG BASE TABLET / ORAL 2004-03-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076374-002 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 12.5MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076374-003 QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 25MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076374-001 QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 10MG BASE TABLET / ORAL 2004-03-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076374-002 QUINAPRIL HYDROCHLORIDE 12.5MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076374-003 QUINAPRIL HYDROCHLORIDE 25MG;EQ 20MG BASE TABLET / ORAL 2004-03-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076374-003 QUINARETIC 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076374-003 QUINARETIC 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076374-003 QUINARETIC 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076374-003 QUINARETIC 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076374-003 QUINARETIC 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076374-003 QUINARETIC 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A076374-003 QUINARETIC 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A076374-003 QUINARETIC 25MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076374-001 QUINARETIC 12.5MG;EQ 10MG BASE TABLET / ORAL AB 2004-03-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A076374-002 QUINARETIC 12.5MG;EQ 20MG BASE TABLET / ORAL AB 2004-03-31 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
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 HCL and Hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength QUINAPRIL HYDROCHLORIDE 10 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33067B3N2M Internal UNII lookup 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310796 Internal RxNorm lookup 310797 Internal RxNorm lookup 310809 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43386-710-03 Quinapril HCL and Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 9 43386-710-05 Quinapril HCL and Hydrochlorothiazide 500 in 1 BOTTLE TABLET 500 9 43386-710-09 Quinapril HCL and Hydrochlorothiazide 90 in 1 BOTTLE TABLET 90 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 QUINAPRIL HYDROCHLORIDE ACTIVE INGREDIENT 33067B3N2M QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 QUINAPRILAT ACTIVE MOIETY 34SSX5LDE5 QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 MAGNESIUM HYDROXIDE INACTIVE INGREDIENT NBZ3QY004S QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [GAVIS PHARMACEUTICALS, LLC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-710 QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS,INC.] 9 Current NDC, Legacy NDC, 3 package rows 20240131_383ecaa6-29c8-4280-a442-c47f101d7c88.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43386-710-03 43386071003 30 TABLET in 1 BOTTLE (43386-710-03) 30 tablet 2012-06-18 0000-00-00 No No Current 43386-710-05 43386071005 500 TABLET in 1 BOTTLE (43386-710-05) 500 tablet 2011-07-15 0000-00-00 No No Current 43386-710-09 43386071009 90 TABLET in 1 BOTTLE (43386-710-09) 90 tablet 2011-07-15 0000-00-00 No No Current