Quinidine gluconate

Product NDC: 71930-016
11-digit product format: 719300016
Labeler code: 71930
Product ID: 71930-016_d4e8ed08-f426-4fdb-9dd3-d46730e9f81b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quinidine gluonate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Eywa Pharma Inc
Application: ANDA212589
Marketing category: ANDA
Marketing start: 2022-03-20
Substance: QUINIDINE GLUCONATE
Active strength: 324 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212589-001	QUINIDINE GLUCONATE	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-09-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212589-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		2021-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		2021-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL		2021-09-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212589-001	QUINIDINE GLUCONATE	324MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-09-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212589-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212589-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212589-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212589-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212589-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212589-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212589-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212589-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212589-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212589-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212589-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212589-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212589-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212589-001	AB	1	`8072bd15b7f6…`
2022-04-04 05:41 UTC	2022-04	A212589-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212589-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212589-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212589-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212589-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212589-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212589-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212589-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212589-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212589-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212589-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212589-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212589-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212589-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212589-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212589-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Quinidine gluconate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUINIDINE GLUCONATE	324 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R6875N380F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
852920	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4db375a3-0cff-4fa7-af7a-2a49e0b922d0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
5c89f85a-bde6-5cf8-a351-de14631f6a68	Product name	2	20220315
3cea42cf-df28-7a4d-1e04-432ad7cc2928	Product name	1	20140508
607c7c15-7bf2-457f-7c66-b7729171afe6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71930-016-12	Quinidine gluconate	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71930-016-12	EA - Each	71930-016	eb88db17-5586-46d8-bb1e-7c796c7c9bae	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71930-016	QUINIDINE GLUCONATE (QUINIDINE GLUONATE) TABLET, EXTENDED RELEASE [EYWA PHARMA INC]	2	Current NDC, Legacy NDC, 1 package rows	20220320_4db375a3-0cff-4fa7-af7a-2a49e0b922d0.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 gluconate	QUINIDINE GLUONATE	Eywa Pharma Inc	4db375a3-0cff-4fa7-af7a-2a49e0b922d0	2021-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212589 application number: ANDA212589 ndc (product): 71930-016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R6875N380F	QUINIDINE GLUCONATE	7054-25-3	QUINIDINE GLUCONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
852920	quiNIDine gluconate 324 MG Extended Release Oral Tablet	PSN	4db375a3-0cff-4fa7-af7a-2a49e0b922d0	2
852920	quinidine gluconate 324 MG Extended Release Oral Tablet	SCD	4db375a3-0cff-4fa7-af7a-2a49e0b922d0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71930-016-12	71930001612	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-016-12)	2022-03-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx Only QUINIDINE GLUCONATE EXTENDED-RELEASE TABLETS USP	Eywa Pharma Inc \| Wes Pharma Inc	2021-12-29	Human Prescription Drug Label	2