Propafenone Hydrochloride

Product NDC: 63629-1989
11-digit product format: 636291989
Labeler code: 63629
Product ID: 63629-1989_1a40d563-a1f1-4a18-b7db-b6a460f0a33d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propafenone Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076550
Marketing category: ANDA
Marketing start: 2015-03-31
Substance: PROPAFENONE HYDROCHLORIDE
Active strength: 300 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
A076550-001	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23
A076550-002	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23
A076550-003	PROPAFENONE HYDROCHLORIDE	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076550-001	AB
A076550-002	AB
A076550-003	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	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-002	PROPAFENONE HYDROCHLORIDE	225MG	TABLET / ORAL	AB	2004-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-003	PROPAFENONE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2004-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076550-001	PROPAFENONE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2004-04-23	`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	A076550-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076550-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076550-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076550-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076550-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076550-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076550-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076550-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076550-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076550-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076550-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076550-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076550-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076550-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076550-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076550-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076550-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076550-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076550-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076550-001	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	300 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
7bcc5d3b-b2c9-4753-9eef-b5360538f5ee	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
63629-1989-1	Propafenone Hydrochloride	100 in 1 BOTTLE	TABLET, COATED	100		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1989-1	EA - Each	63629-1989	ca4ccf49-9b00-45f0-a96d-8b2bd0bb0e8e	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1989	PROPAFENONE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 1 package rows	20240820_7bcc5d3b-b2c9-4753-9eef-b5360538f5ee.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	A-S Medication Solutions	41b4e503-60a6-4662-a6f9-46ecf93d930a	2026-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	680a803d-3d4d-4ca3-b1ce-7d7e3ff8a626	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	5c8cebcd-699f-4c4c-900b-94e0fe519345	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	739b7624-952d-4343-b720-974d30e284d9	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	7202aed6-40a9-2bff-e053-2a95a90ae752	2025-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	a6ac2a70-e0ec-4fcd-8732-5f1637be1e60	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	617faff7-d9e4-477d-ab2c-aded5c129a86	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	8d1be333-be2b-4064-86a4-c2ad9ad07b83	2025-09-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	9da7e6d2-64da-43cd-9575-b2b0d5d412dc	2024-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	7bcc5d3b-b2c9-4753-9eef-b5360538f5ee	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550 ndc (product): 63629-1989
Propafenone Hydrochloride	PROPAFENONE HYDROCHLORIDE	Bryant Ranch Prepack	2492317c-8b04-477e-a5d2-53e791fface9	2023-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076550 application number: ANDA076550

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
861430	propafenone HCl 300 MG Oral Tablet	PSN	7bcc5d3b-b2c9-4753-9eef-b5360538f5ee	104
861430	propafenone hydrochloride 300 MG Oral Tablet	SCD	7bcc5d3b-b2c9-4753-9eef-b5360538f5ee	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1989-1	63629198901	100 TABLET, COATED in 1 BOTTLE (63629-1989-1)	2021-02-02	0000-00-00	No	No	Current