Home NDC 50090-1134 Propafenone Hydrochloride
Product NDC 50090-1134
11-digit product format 500901134
Labeler code 50090
Product ID 50090-1134_f293d2ab-428b-47bb-8995-07c65f2c5ff1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propafenone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA075938
Marketing category ANDA
Marketing start 2002-10-17
Marketing end 0000-00-00
Substance PROPAFENONE HYDROCHLORIDE
Active strength 225 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-1134-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-1134-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-1134-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-1134-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-1134-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-1134-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-1134-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-1134-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-1134-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-1134-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-1134-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-1134-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-1134-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-1134-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-1134-0 1332a3947898…d4bfe170f9cd…
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.
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-1134-0 Propafenone Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1134 PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 7 Legacy NDC, 1 package rows 20210616_5b3890cc-9078-4e11-b396-a26f75da3eb2.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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-1134-0 50090113400 60 TABLET, FILM COATED in 1 BOTTLE (50090-1134-0) 2014-11-28 0000-00-00 No No Current