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⚪no package photo
in the FDA label

PROPAFENONE HYDROCHLORIDE 150 mg Tablet, Film Coated, 250-count

by Sun Pharmaceutical Industries, Inc. · 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-551-03)
NDC 53489-0551-03
🏷️ FDA NDC (as labeled) 53489-551-03 billing pads the product segment with a zero
This package
Contains250-count Pack sizes5 compare ↓
Also comes in: 30 tablets 53489-0551-07 100 tablets 53489-0551-01 500 tablets 53489-0551-05 1000 tablets 53489-0551-10
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced 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

⚠️
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

FDA NDC (as labeled) 53489-551-03
Product NDC 53489-551
11-digit billing NDC 53489055103
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
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 TAB
FDB brand name Propafenone Hcl
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 53489-551-03 — 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 → 53489-0551-03. 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.

🏭 Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES INC
FDA applicationANDA075998 (ANDA)
Labeler code53489
Product typeHuman Prescription Drug
Portfolio889 products on file
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.

🩺 Clinical

Label name PROPAFENONE HCL 150 MG TAB Ingredient Propafenone Hcl
📖 What it is MedlinePlus · NLM

Propafenone is used to treat arrhythmia (irregular heartbeat) and to maintain a normal heart rate. Propafenone is in a class of medications called antiarrhythmics. It works by acting on the heart muscle to improve the heart's rhythm.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Think of it as an electrical 'slow-down' for your heart. Your heart has channels that carry electrical signals triggering each beat — propafenone partially blocks those channels so...
  • What exactly is propafenone doing for my heart?
  • Yes, a few important ones. Grapefruit juice can raise propafenone levels in your blood, so it's best to avoid it. Several medications — including some antidepressants like paroxeti...
  • Are there foods or common medications I should avoid while taking this?
📖 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets 100 tablets 500 tablets 1000 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Propafenone Hydrochloride 150 mg 59651-0256-01 Aurobindo 100 tablets $0.111 AB Availability likely —
Propafenone Hydrochloride 150 mg 60687-0709-01 American 1 tablet $0.111 AB Availability likely —
Propafenone Hydrochloride 150 mg 60687-0930-01 American 1 tablet $0.111 AB Availability likely —
Propafenone Hydrochloride 150 mg 62559-0230-01 ANI 100 tablets $0.111 AB Availability likely —
Propafenone Hydrochloride 150 mg 64380-0165-01 Strides 300 tablets $0.111 AB Availability likely —
Propafenone Hydrochloride 150 mg 64380-0269-01 Strides 300 tablets $0.111 AB Availability likely —
Propafenone HCl 150 mg 00591-0582-01 Actavis 100 tablets $0.114 — 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 —
Propafenone Hydrochloride 150 mgthis 53489-0551-03 Sun 250 tablets — — Discontinued —
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.

📦 Packaging — all sizes for this product

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

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

Pack size FAQ

What quantity is in NDC 53489-0551-03?
NDC 53489-0551-03 is a 250-count package — 250 tablet, film coated in 1 bottle, plastic.
What is the difference between NDC 53489-0551-03 and NDC 53489-0551-07?
Both are PROPAFENONE HYDROCHLORIDE 150 mg Tablet, Film Coated — the drug itself is identical. NDC 53489-0551-03 is the 250-count package, 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?
Bill NDC 53489-0551-03 — the 11-digit billing format is 53489055103. 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.

🧭 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 The FDA label for this product carries no photos.
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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 price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 FDA registers it as 53489-551-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 53489-0551-03, written without dashes as 53489055103. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 53489-0551-03, the first segment (53489) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (0551) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
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), 100 tablets (53489-0551-01), 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.

📄 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.
← 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.