PROPAFENONE HYDROCHLORIDE

Product NDC: 59651-257
11-digit product format: 596510257
Labeler code: 59651
Product ID: 59651-257_b59b252f-8b73-4f72-8d01-4d2076c18fa6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROPAFENONE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA202445
Marketing category: ANDA
Marketing start: 2019-10-25
Substance: PROPAFENONE HYDROCHLORIDE
Active strength: 225 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202445-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11
A202445-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11
A202445-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202445-001	AB
A202445-002	AB
A202445-003	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	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2016-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2016-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202445-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2016-05-11	`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	A202445-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202445-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202445-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202445-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202445-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202445-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202445-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202445-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202445-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202445-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202445-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202445-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202445-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202445-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202445-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202445-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202445-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202445-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202445-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202445-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: PROPAFENONE HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPAFENONE HYDROCHLORIDE	225 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
861424	Internal RxNorm lookup
861427	Internal RxNorm lookup
861430	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
0c887381-42fe-4f37-858a-d9ffb218dd1c	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
06783798-d93a-d4be-8416-24bb30819d48	Product name	2	20160630
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-257-01	PROPAFENONE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100		4
59651-257-33	PROPAFENONE HYDROCHLORIDE	300 in 1 BOTTLE	TABLET, FILM COATED	300		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-257-01	EA - Each	59651-257	5417be39-5493-4176-9074-9b94c5f5c01e	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-257	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	4	Current NDC, Legacy NDC, 2 package rows	20230722_0c887381-42fe-4f37-858a-d9ffb218dd1c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	c8ad1f0f-0e95-4868-a2af-e193c1833841	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202445 application number: ANDA202445
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	faa8e971-4b4f-43db-be97-33acc16dcdc7	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202445 application number: ANDA202445
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	80f174e1-f249-4f34-806d-20e643084429	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202445 application number: ANDA202445
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	0c887381-42fe-4f37-858a-d9ffb218dd1c	2023-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202445 application number: ANDA202445 ndc (product): 59651-257

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
861427	propafenone HCl 225 MG Oral Tablet	PSN	80f174e1-f249-4f34-806d-20e643084429	100
861427	propafenone hydrochloride 225 MG Oral Tablet	SCD	80f174e1-f249-4f34-806d-20e643084429	100
861424	propafenone HCl 150 MG Oral Tablet	PSN	0c887381-42fe-4f37-858a-d9ffb218dd1c	4
861427	propafenone HCl 225 MG Oral Tablet	PSN	0c887381-42fe-4f37-858a-d9ffb218dd1c	4
861430	propafenone HCl 300 MG Oral Tablet	PSN	0c887381-42fe-4f37-858a-d9ffb218dd1c	4
861424	propafenone hydrochloride 150 MG Oral Tablet	SCD	0c887381-42fe-4f37-858a-d9ffb218dd1c	4
861427	propafenone hydrochloride 225 MG Oral Tablet	SCD	0c887381-42fe-4f37-858a-d9ffb218dd1c	4
861430	propafenone hydrochloride 300 MG Oral Tablet	SCD	0c887381-42fe-4f37-858a-d9ffb218dd1c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-257-01	59651025701	100 TABLET, FILM COATED in 1 BOTTLE (59651-257-01)	2019-10-25	0000-00-00	No	No	Current
59651-257-33	59651025733	300 TABLET, FILM COATED in 1 BOTTLE (59651-257-33)	2019-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	2026-04-20	HUMAN PRESCRIPTION DRUG LABEL	100
PROPAFENONE HYDROCHLORIDE	Aurobindo Pharma Limited	2023-07-21	Human Prescription Drug Label	4