Home NDC 53489-553 PROPAFENONE HYDROCHLORIDE
Product NDC 53489-553
11-digit product format 534890553
Labeler code 53489
Product ID 53489-553_90501597-9f9b-483d-a46b-7e60c7b45cad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name propafenone hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA075998
Marketing category ANDA
Marketing start 2001-11-29
Marketing end 0000-00-00
Substance PROPAFENONE HYDROCHLORIDE
Active strength 300 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075998-001 PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 A075998-002 PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 A075998-003 PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29
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 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL 2001-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075998-002 PROPAFENONE HYDROCHLORIDE 225MG TABLET / ORAL 2001-11-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075998-003 PROPAFENONE HYDROCHLORIDE 300MG TABLET / ORAL 2001-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075998-001 PROPAFENONE HYDROCHLORIDE 150MG TABLET / ORAL AB 2001-11-29 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 87 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded propafenone hydrochloride ACTIVE INGREDIENT 33XCH0HOCD PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 propafenone ACTIVE MOIETY 68IQX3T69U PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 Carnauba wax INACTIVE INGREDIENT R12CBM0EIZ PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 polydextrose INACTIVE INGREDIENT VH2XOU12IE PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 povidones INACTIVE INGREDIENT FZ989GH94E PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 starch, corn INACTIVE INGREDIENT O8232NY3SJ PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3 triacetin INACTIVE INGREDIENT XHX3C3X673 PROPAFENONE HYDROCHLORIDE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL CO., INC.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 53489-553-01 53489055301 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-01) 2001-11-29 0000-00-00 No No Current 53489-553-03 53489055303 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-03) 2001-11-29 0000-00-00 No No Current 53489-553-05 53489055305 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-05) 2001-11-29 0000-00-00 No No Current 53489-553-07 53489055307 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-07) 2001-11-29 0000-00-00 No No Current 53489-553-10 53489055310 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-553-10) 2001-11-29 0000-00-00 No No Current