Home NDC 0185-1047-01 Quinidine Sulfate
Product NDC 0185-1047
Requested package NDC 0185-1047-01
11-digit product format 001851047
Labeler code 0185
Product ID 0185-1047_e297490d-c30d-48e2-a7b8-25c6429ddaef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Quinidine Sulfate
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA088072
Marketing category ANDA
Marketing start 1983-09-26
Marketing end 2025-05-31
Substance QUINIDINE SULFATE
Active strength 300 mg/1
Pharmacologic classes Antiarrhythmic [EPC], Cytochrome P450 2D6 Inhibitor [EPC], Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0185-1047 0185-1047-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0185-1047 0185-1047-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A088072-001 QUINIDINE SULFATE QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 A088072-002 QUINIDINE SULFATE QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982
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 3 · 82 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 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL AB 1983-09-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088072-001 QUINIDINE SULFATE 300MG TABLET / ORAL RS 1983-09-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A088072-002 QUINIDINE SULFATE 200MG TABLET / ORAL RS, Approved before 1982 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded QUINIDINE SULFATE ACTIVE INGREDIENT J13S2394HE QUINIDINE SULFATE TABLET [EON LABS, INC.] 3 QUINIDINE ACTIVE MOIETY ITX08688JL QUINIDINE SULFATE TABLET [EON LABS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U QUINIDINE SULFATE TABLET [EON LABS, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ QUINIDINE SULFATE TABLET [EON LABS, INC.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 QUINIDINE SULFATE TABLET [EON LABS, INC.] 3 ZINC STEARATE INACTIVE INGREDIENT H92E6QA4FV QUINIDINE SULFATE TABLET [EON LABS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0185-1047 QUINIDINE SULFATE TABLET [EON LABS, INC.] 8 Legacy NDC 20220513_a10b6ded-4fe0-4059-bd77-c45acc3c876d.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0185-1047-01 00185104701 100 TABLET in 1 BOTTLE (0185-1047-01) 100 tablet 1983-09-26 2025-05-31 No No Current