Propafenone Hydrochloride

Product NDC: 63629-2105
11-digit product format: 636292105
Labeler code: 63629
Product ID: 63629-2105_ae1bf45c-2106-497f-a42a-8fcc4ce3d9ad
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: 150 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…`

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 · 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 ndc (product): 63629-2105
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
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

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	150 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
861424	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
9da7e6d2-64da-43cd-9575-b2b0d5d412dc	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
63629-2105-1	Propafenone Hydrochloride	100 in 1 BOTTLE	TABLET, COATED	100		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2105-1	EA - Each	63629-2105	c46cb798-cd49-48d2-9b50-5843bd791b46	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2105	PROPAFENONE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 1 package rows	20241004_9da7e6d2-64da-43cd-9575-b2b0d5d412dc.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
861424	propafenone HCl 150 MG Oral Tablet	PSN	9da7e6d2-64da-43cd-9575-b2b0d5d412dc	105
861424	propafenone hydrochloride 150 MG Oral Tablet	SCD	9da7e6d2-64da-43cd-9575-b2b0d5d412dc	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2105-1	63629210501	100 TABLET, COATED in 1 BOTTLE (63629-2105-1)	2021-01-29	0000-00-00	No	No	Current