propafenone hydrochloride

Product NDC: 68462-410
11-digit product format: 684620410
Labeler code: 68462
Product ID: 68462-410_9b3e09a2-c396-425e-a1dc-e37cd44b612d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propafenone hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA205268
Marketing category: ANDA
Marketing start: 2017-09-08
Substance: PROPAFENONE HYDROCHLORIDE
Active strength: 425 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205268-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08
A205268-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08
A205268-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A205268-001	AB
A205268-002	AB
A205268-003	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.

Product history page 1 of 4 · 123 observed 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	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205268-002	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205268-003	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205268-001	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2017-09-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205268-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205268-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205268-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205268-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205268-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205268-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205268-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205268-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205268-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205268-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205268-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205268-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205268-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205268-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205268-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205268-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205268-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205268-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205268-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205268-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205268-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205268-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205268-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205268-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205268-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205268-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205268-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
propafenone hydrochloride	PROPAFENONE HYDROCHLORIDE	Northstar Rx LLC	2ecd6452-ccc3-493f-9a4a-69f0fbf67a42	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205268 application number: ANDA205268
propafenone hydrochloride	PROPAFENONE HYDROCHLORIDE	Glenmark Pharmaceuticals Inc., USA	d818af31-2535-4595-82fe-fd7abf66fd6c	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205268 application number: ANDA205268 ndc (product): 68462-410

Additional Listing Data#

Finished product: Yes
Brand name base: propafenone hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPAFENONE HYDROCHLORIDE	425 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33XCH0HOCD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861156	Internal RxNorm lookup
861164	Internal RxNorm lookup
861171	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
d818af31-2535-4595-82fe-fd7abf66fd6c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
559c7edd-6d87-934f-8fcc-0cd5e9651949	Product name	7	20240226
06783798-d93a-d4be-8416-24bb30819d48	Product name	2	20160630

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-410-60	propafenone hydrochloride	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-410-60	EA - Each	68462-410	6aa777f9-9617-4c19-9e24-ef0c635979ee	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-410	PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]	7	Current NDC, Legacy NDC, 1 package rows	20240104_d818af31-2535-4595-82fe-fd7abf66fd6c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33XCH0HOCD	PROPAFENONE HYDROCHLORIDE	34183-22-7	PROPAFENONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861156	propafenone HCl 225 MG 12HR Extended Release Oral Capsule	PSN	d818af31-2535-4595-82fe-fd7abf66fd6c	8
861164	propafenone HCl 325 MG 12HR Extended Release Oral Capsule	PSN	d818af31-2535-4595-82fe-fd7abf66fd6c	8
861171	propafenone HCl 425 MG 12HR Extended Release Oral Capsule	PSN	d818af31-2535-4595-82fe-fd7abf66fd6c	8
861156	12 HR propafenone hydrochloride 225 MG Extended Release Oral Capsule	SCD	d818af31-2535-4595-82fe-fd7abf66fd6c	8
861164	12 HR propafenone hydrochloride 325 MG Extended Release Oral Capsule	SCD	d818af31-2535-4595-82fe-fd7abf66fd6c	8
861171	12 HR propafenone hydrochloride 425 MG Extended Release Oral Capsule	SCD	d818af31-2535-4595-82fe-fd7abf66fd6c	8
861156	propafenone hydrochloride 225 MG 12 HR Extended Release Oral Capsule	SY	d818af31-2535-4595-82fe-fd7abf66fd6c	8
861164	propafenone hydrochloride 325 MG 12 HR Extended Release Oral Capsule	SY	d818af31-2535-4595-82fe-fd7abf66fd6c	8
861171	propafenone hydrochloride 425 MG 12 HR Extended Release Oral Capsule	SY	d818af31-2535-4595-82fe-fd7abf66fd6c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-410-60	68462041060	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-410-60)	2017-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
propafenone hydrochloride	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	8