Home NDC 64380-164 PROPAFENONE HYDROCHLORIDE
Product NDC 64380-164
11-digit product format 643800164
Labeler code 64380
Product ID 64380-164_3c3e948d-7eef-4a8b-8155-aef063cd1678
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROPAFENONE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA075938
Marketing category ANDA
Marketing start 2022-08-01
Substance PROPAFENONE HYDROCHLORIDE
Active strength 225 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64380-164-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64380-164-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64380-164-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64380-164-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64380-164-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64380-164-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64380-164-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64380-164-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64380-164-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64380-164-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64380-164-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64380-164-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64380-164-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64380-164-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 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 · 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 A075938-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2002-10-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075938-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL AB 2002-10-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075938-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2002-10-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075938-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2002-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075938-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL AB 2002-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075938-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL AB RS 2002-10-17 caaa826d4ba7…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…
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPAFENONE HYDROCHLORIDE 225 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861424 Internal RxNorm lookup 861427 Internal RxNorm lookup 861430 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 64380-164-01 PROPAFENONE HYDROCHLORIDE 300 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 300 6 64380-164-02 PROPAFENONE HYDROCHLORIDE 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-164 PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] 6 Current NDC, Legacy NDC, 2 package rows 20250330_a96f9c6f-4c9c-4406-bca8-08bf9a4af1f4.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 ndc (product): 64380-164
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 64380-164-01 64380016401 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-164-01) 2022-08-01 0000-00-00 No No Current 64380-164-02 64380016402 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-164-02) 2022-08-01 0000-00-00 No No Current