Quinidine Sulfate

Product NDC: 0185-1047
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0185-1047		D	Discontinued by firm	2026-08-11
excluded package	package	0185-1047	0185-1047-01	D	Discontinued by firm	2026-08-11
excluded package	package	0185-1047	0185-1047-10	D	Discontinued by firm	2026-08-11

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 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-1047-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-1047-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-1047-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-1047-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0185-1047-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0185-1047-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0185-1047-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0185-1047-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0185-1047-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0185-1047-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0185-1047-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0185-1047-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0185-1047-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0185-1047-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A088072-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A088072-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A088072-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A088072-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088072-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A088072-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088072-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A088072-002	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-1047-01	EA - Each	0185-1047	4f88a295-47e1-46b0-aece-0302b79f6213	1	2012-07-24
0185-1047-10	EA - Each	0185-1047	e3a4e9d9-1837-46b0-bc72-aabf548039e4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUINIDINE SULFATE	QUINIDINE SULFATE TABLET	EPIC PHARMA, LLC	b0d6341b-d880-4f0b-8844-bc788c03004a	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088072 application number: ANDA088072

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J13S2394HE	QUINIDINE SULFATE	6591-63-5	QUINIDINE SULFATE

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	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quinidine Sulfate Tablets, USP 200 mg and 300 mg	Eon Labs, Inc.	2019-09-13	HUMAN PRESCRIPTION DRUG LABEL	8