Home NDC 72162-2618 PROPAFENONE HYDROCHLORIDE
Product NDC 72162-2618
11-digit product format 721622618
Labeler code 72162
Product ID 72162-2618_49304df7-a225-49e7-b9e5-3117950887b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROPAFENONE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA202445
Marketing category ANDA
Marketing start 2019-10-25
Substance PROPAFENONE HYDROCHLORIDE
Active strength 300 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 43 .
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 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.
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 · 129 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 2026-09-14 22:38:34 2026-08 A202445-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202445-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL AB 2016-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202445-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2016-05-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202445-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2016-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202445-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL AB 2016-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202445-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL AB 2016-05-11 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72162-2618-1 PROPAFENONE HYDROCHLORIDE 100 in 1 BOTTLE TABLET, FILM COATED 100 100
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 ndc (product): 72162-2618 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72162-2618-1 72162261801 100 TABLET, FILM COATED in 1 BOTTLE (72162-2618-1) 2026-04-20 No No Current