PROPAFENONE HYDROCHLORIDE

Product NDC: 64380-268
11-digit product format: 643800268
Labeler code: 64380
Product ID: 64380-268_c59340fa-0b07-454a-bf5a-c49b54bfd42c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROPAFENONE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA075938
Marketing category: ANDA
Marketing start: 2025-05-05
Substance: PROPAFENONE HYDROCHLORIDE
Active strength: 225 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	RLD / RS	Approval date
A075938-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17
A075938-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17
A075938-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075938-001	AB
A075938-002	AB
A075938-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB		2002-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	RS	2002-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075938-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2002-10-17	`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	A075938-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075938-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075938-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075938-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075938-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075938-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075938-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075938-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075938-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075938-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075938-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075938-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075938-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075938-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075938-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075938-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075938-001	AB	1	`8072bd15b7f6…`

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	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
c65253ab-937f-4982-b841-69c2b9f9ccdb	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
64380-268-01	PROPAFENONE HYDROCHLORIDE	300 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	300		3
64380-268-02	PROPAFENONE HYDROCHLORIDE	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-268-01	EA - Each	64380-268	94a74d09-b84e-4d17-8d72-f0fdb16f0f9f	1	2025-06-13
64380-268-02	EA - Each	64380-268	acc9b84e-9af9-45d7-ad00-9e3c2ea96dba	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-268	PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]	2	Current NDC, 2 package rows	20250507_c65253ab-937f-4982-b841-69c2b9f9ccdb.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	American Health Packaging	da08c286-b930-463a-858a-efc54f12019f	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	American Health Packaging	343e4ad7-05e2-4e6c-8f8e-91c07739cae2	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	c65253ab-937f-4982-b841-69c2b9f9ccdb	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938 ndc (product): 64380-268
PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	a96f9c6f-4c9c-4406-bca8-08bf9a4af1f4	2025-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075938 application number: ANDA075938

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
861424	propafenone HCl 150 MG Oral Tablet	PSN	c65253ab-937f-4982-b841-69c2b9f9ccdb	3
861427	propafenone HCl 225 MG Oral Tablet	PSN	c65253ab-937f-4982-b841-69c2b9f9ccdb	3
861430	propafenone HCl 300 MG Oral Tablet	PSN	c65253ab-937f-4982-b841-69c2b9f9ccdb	3
861424	propafenone hydrochloride 150 MG Oral Tablet	SCD	c65253ab-937f-4982-b841-69c2b9f9ccdb	3
861427	propafenone hydrochloride 225 MG Oral Tablet	SCD	c65253ab-937f-4982-b841-69c2b9f9ccdb	3
861430	propafenone hydrochloride 300 MG Oral Tablet	SCD	c65253ab-937f-4982-b841-69c2b9f9ccdb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
64380-268-01	64380026801	300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-01)	2025-05-05	No	No	Current
64380-268-02	64380026802	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-268-02)	2025-05-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPAFENONE HYDROCHLORIDE	Strides Pharma Science Limited	2025-09-01	HUMAN PRESCRIPTION DRUG LABEL	3