Propafenone Hydrochloride

Product NDC: 60687-537
Requested package NDC: 60687-537-01
11-digit product format: 606870537
Labeler code: 60687
Product ID: 60687-537_e271f15f-9dfd-8e72-e053-2a95a90ab2a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propafenone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA075938
Marketing category: ANDA
Marketing start: 2020-06-01
Marketing end: 2023-02-28
Substance: PROPAFENONE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Antiarrhythmic [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60687-537	60687-537-01	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

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

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-537-01	EA - Each	60687-537	f9a5ea4b-7e99-4adc-b4af-886a328132dc	1	2020-07-13
60687-537-11	EA - Each	60687-537	9bf3cedc-949c-49c1-8dbc-4d91506bb103	1	2020-07-13

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-537-01	60687053701	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-537-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-537-11)	100 blister pack	2020-06-01	2023-02-28	No	No	Current