Home › NDC Lookup › Ingredients › Propafenone Hydrochloride › 53489-0551-01
⚪image loading
(from DailyMed)

Propafenone Hydrochloride 150 mg Tablet, Film Coated, 100-count — NDC 53489-551-01 (Billing 53489-0551-01)

by Sun Pharmaceutical Industries, Inc. · 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Propafenone Hydrochloride 150 mg Tablet, Film Coated from Sun Pharmaceutical Industries, Inc., no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $0.1384 per tablet (NADAC). It is the main listing for this product, which comes in 5 package sizes.

NDC 53489-0551-01
🏷️ FDA NDC (as labeled) 53489-551-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1384 NADAC Per package$13.84 / 100 tablets Pack sizes5 compare ↓
Main listing for product 53489-551 · Also comes in: 30 tablets 53489-551-07 250 tablets 53489-551-03 500 tablets 53489-551-05 1000 tablets 53489-551-10
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 53489-551-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
53489 labeler · 551 product · 01 package
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 5348955101 4
FDA record last changed
Mar 13, 2024
⚠️
Other active recalls for Propafenone Hydrochloride (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0316-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0351-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0352-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0315-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2021. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53489-551-01
Product NDC 53489-551
11-digit billing NDC 53489055101
NCPDP billing unit EA — each (per item)
Application # ANDA075998
Established class (EPC) Antiarrhythmic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2021)
Route ORAL
Dosage form TABLET, FILM COATED
Substance PROPAFENONE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 013646
GCN 12431
HICL code 004833
Ingredient (HICL) Propafenone Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A2
Therapeutic class — intermediate (HIC2) Cardiac Depressants
HIC3 code A2A
Therapeutic class — specific (HIC3) Antiarrhythmics
AHFS code 24:04.04.12
AHFS class Class Ic Antiarrhythmics
FDB label name PROPAFENONE HCL 150 MG TABLET
FDB brand name Propafenone Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 013646
  • GCN: 12431
  • HICL (First Databank): 004833
  • AHFS class code: 24:04.04.12
Why two NDCs? The FDA registers this code as 53489-551-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 53489-0551-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name PROPAFENONE HCL 150 MG TABLET Ingredient Propafenone Hcl
📗 Our plain-language guide HelloPharmacist
  • Propafenone helps keep your heart rhythm steady. The extended-release capsules are used to prolong the time before symptomatic atrial fibrillation returns. The tablets are also use...
  • Take it by mouth exactly as prescribed. Tablets are usually taken about every 8 hours, and the extended-release capsules about every 12 hours with or without food. Do not crush the...
  • Dizziness, palpitations, nausea, taste changes, tiredness, and constipation are common. Call right away for fainting, a new racing or irregular heartbeat, swelling, trouble breathi...
  • What side effects should I expect, and when should I call?
📖 Read our full Propafenone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.138 $13.84 / 100 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Apr 2022 Sep 2022 Feb 2024 $0.154 $0.130
▲ Up 6% over the last 15 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
53489-0551-01 You're viewing this Main listing 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC $0.1384 / ea $13.84 2001-11-29 — Discontinued by firm
53489-0551-03 53489-551-03 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC — — 2001-11-29 — Discontinued by firm
53489-0551-05 53489-551-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC — — 2001-11-29 — Discontinued by firm
53489-0551-07 53489-551-07 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC — — 2001-11-29 — Discontinued by firm
53489-0551-10 53489-551-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC — — 2001-11-29 — Discontinued by firm

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 bottle, plastic.
How does this package differ from NDC 53489-0551-07?
Both are Propafenone Hydrochloride 150 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 53489-0551-07 is the 30 tablets package.
What NDC number is used to bill for this package of Propafenone Hydrochloride 150 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Propafenone HCl 150 mg 00591-0582-01 Actavis 100 tablets $0.114 — Discontinued save 18%
Propafenone Hydrochloride 150 mg 59651-0256-01 Aurobindo 100 tablets $0.115 AB Availability likely save 17%
Propafenone Hydrochloride 150 mg 60687-0709-01 American 1 tablet $0.115 AB Availability likely save 17%
Propafenone Hydrochloride 150 mg 60687-0930-01 American 1 tablet $0.115 AB Availability likely save 17%
Propafenone Hydrochloride 150 mg 62559-0230-01 ANI 100 tablets $0.115 AB Availability likely save 17%
Propafenone Hydrochloride 150 mg 64380-0165-01 Strides 300 tablets $0.115 AB Availability likely save 17%
Propafenone Hydrochloride 150 mg 64380-0269-01 Strides 300 tablets $0.115 AB Availability likely save 17%
Propafenone Hydrochloride 150 mgthis 53489-0551-01 Sun 100 tablets $0.138 — Discontinued —
Propafenone Hydrochloride 150 mg 51407-0015-01 Golden 100 tablets — AB FDA listed —
Propafenone Hydrochloride 150 mg 63629-2105-01 Bryant 100 tablets — AB FDA listed —
Propafenone Hydrochloride 150 mg 71335-2780-01 Bryant 30 tablets — AB FDA listed —
Propafenone Hydrochloride 150 mg 72162-1751-01 Bryant 100 tablets — AB FDA listed —
Propafenone Hydrochloride 150 mg 72162-2616-01 Bryant 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Propafenone inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationANDA075998 (ANDA)
Labeler code53489
Product typeHuman Prescription Drug
Portfolio891 products on file

More NDCs from Sun Pharmaceutical Industries, Inc. labeler code 53489

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 30 tablets (53489-0551-07), 250 tablets (53489-0551-03), 500 tablets (53489-0551-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 53489-0500-01 · Sun 53489-0647-01 · Sun →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.