Propafenone Hydrochloride 425 mg Capsule, Extended Release, 60-count
by Actavis Pharma, Inc. · 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2287-60)
NDC 00591-2287-60
🏷️ FDA NDC (as labeled)
0591-2287-60
billing pads the labeler segment with a zero
This package
Also comes in:
8855 capsules 00591-2287-00
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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 Jan 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)
0591-2287-60
Product NDC
0591-2287
11-digit billing NDC
00591228760
NCPDP billing unit
EA — each (per item)
SPL Set ID
706f24c4-1514-4434-88a9-dc8e80327148
DEA schedule
Non-controlled
Marketing category
DRUG FOR FURTHER PROCESSING
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Jan 2021)
Marketing start
2015-09-22
Dosage form
CAPSULE, EXTENDED RELEASE
Substance
PROPAFENONE HYDROCHLORIDE
GPI-14
35300050006940
GPI class
Propafenone HCl ER
GCN Seq No
053541
GCN
21059
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 ER 425 MG CAP
FDB brand name
Propafenone Hcl Er
Legend status
F — Federal legend — prescription drug or device
Why two NDCs?
The FDA registers this code as 0591-2287-60 — a 4-4-2 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 labeler segment → 00591-2287-60. 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
LabelerActavis Pharma, Inc.
Labeler code00591
First marketedSep 2015
Product typeDrug For Further Processing
Portfolio324 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 ER 425 MG CAP 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Propafenone Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.565 | $33.90 / 60 capsules |
| 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
▼ Down 45% over the last 9 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Propafenone Hydrochloride 425 mg 00832-0742-60 | Upsher-Smith | 60 capsules | $0.565 | AB | Availability likely | — |
| Propafenone Hydrochloride 425 mg 16571-0738-06 | Rising | 60 capsules | $0.565 | AB | Availability likely | — |
| propafenone hydrochloride 425 mg 16714-0827-01 | Northstar | 60 capsules | $0.565 | AB | Availability likely | — |
| Propafenone Hydrochloride 425 mg 64380-0186-01 | Strides | 60 capsules | $0.565 | AB | Discontinued | — |
| propafenone hydrochloride 425 mg 68462-0410-60 | Glenmark | 60 capsules | $0.565 | AB | Availability likely | — |
| Propafenone Hydrochloride 425 mgthis 00591-2287-60 | Actavis | 60 capsules | $0.565 | — | Discontinued | — |
| Propafenone Hydrochloride 425 mg 59651-0278-05 | Aurobindo | 500 capsules | — | AB | FDA listed | — |
| Propafenone Hydrochloride 425 mg 68382-0524-05 | Zydus | 500 capsules | — | AB | FDA listed | — |
| Propafenone Hydrochloride 425 mg 69680-0132-60 | Vitruvias | 60 capsules | — | AB | FDA listed | — |
| Propafenone Hydrochloride 425 mg 70771-1527-05 | Zydus | 500 capsules | — | AB | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
🏛️
2015
On the market since
Sep 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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 NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00591-2287-60 You're viewing this | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2287-60) | $0.5650 / ea | $33.90 | 2015-10-15 | Discontinued by firm |
| 00591-2287-00 | 8855 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0591-2287-00) | — | — | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 00591-2287-60?
NDC 00591-2287-60 is a 60-count package — 60 capsule, extended release in 1 bottle, plastic.
What is the difference between NDC 00591-2287-60 and NDC 00591-2287-00?
Both are Propafenone Hydrochloride 425 mg Capsule, Extended Release — the drug itself is identical. NDC 00591-2287-60 is the 60-count package, while NDC 00591-2287-00 is the 8855 capsules package.
What NDC number is used to bill for this package of Propafenone Hydrochloride 425 mg Capsule, Extended Release?
Bill NDC 00591-2287-60 — the 11-digit billing format is 00591228760. 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
Listed for further processing / repackaging
No longer marketed (per FDA listing data)
What "drug for further processing" means
FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.
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) | ✓ Available |
| 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
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 0591-2287-60, 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: 00591-2287-60, written without dashes as 00591228760. 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 00591-2287-60, the first segment (00591) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (2287) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 1 other package presentation of this same product, including 8855 capsules (00591-2287-00). 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?
Actavis Pharma, 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.
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 FDA label FDA SPL
The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.