Home NDC 62135-484 Quinapril
Product NDC 62135-484
11-digit product format 621350484
Labeler code 62135
Product ID 62135-484_09cd5cb9-4fdf-f133-e063-6294a90af691
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quinapril
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA076803
Marketing category ANDA
Marketing start 2005-03-02
Substance QUINAPRIL HYDROCHLORIDE
Active strength 5 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076803-001 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 A076803-002 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 A076803-003 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 A076803-004 QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 1 of 5 · 164 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 2026-02-19 14:30 UTC 2026-02 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076803-001 QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET / ORAL AB 2005-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076803-002 QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET / ORAL AB 2005-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076803-003 QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET / ORAL AB 2005-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076803-004 QUINAPRIL HYDROCHLORIDE EQ 40MG BASE TABLET / ORAL AB 2005-03-02 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Quinapril
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength QUINAPRIL HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33067B3N2M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312748 Internal RxNorm lookup 312749 Internal RxNorm lookup 312750 Internal RxNorm lookup 314203 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 62135-484-60 Quinapril 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-484 QUINAPRIL TABLET, FILM COATED [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20231111_dbc43dbd-94aa-40e2-a9ea-766110cc8687.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62135-484-60 62135048460 60 TABLET, FILM COATED in 1 BOTTLE (62135-484-60) 2023-11-06 No No Current