Home NDC 42806-512 QUINIDINE SULFATE
Product NDC 42806-512
11-digit product format 428060512
Labeler code 42806
Product ID 42806-512_80df716e-b0d6-4b0f-b0f4-879874d7ed05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name quinidine sulfate tablet
Dosage form TABLET
Route ORAL
Labeler EPIC PHARMA, LLC
Application ANDA088072
Marketing category ANDA
Marketing start 2021-12-15
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 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 · 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# Additional Listing Data#
Finished product Yes
Brand name base QUINIDINE SULFATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength QUINIDINE SULFATE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J13S2394HE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 852877 Internal RxNorm lookup 852913 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 42806-512-01 QUINIDINE SULFATE 100 in 1 BOTTLE TABLET 100 2 42806-512-30 QUINIDINE SULFATE 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-512 QUINIDINE SULFATE (QUINIDINE SULFATE TABLET) TABLET [EPIC PHARMA, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231221_b0d6341b-d880-4f0b-8844-bc788c03004a.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 Units Marketing start Marketing end Sample Exclude flag Status 42806-512-01 42806051201 100 TABLET in 1 BOTTLE (42806-512-01) 100 tablet 2021-12-15 0000-00-00 No No Current 42806-512-30 42806051230 30 TABLET in 1 BOTTLE (42806-512-30) 30 tablet 2022-01-02 0000-00-00 No No Current