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Spironolactone 25 mg Tablet, Film Coated, 3-count — NDC 63187-0841-03 package photo

Spironolactone 25 mg Tablet, Film Coated, 3-count

by Proficient Rx LP · 3 TABLET, FILM COATED in 1 BOTTLE (63187-841-03)
NDC 63187-0841-03
🏷️ FDA NDC (as labeled) 63187-841-03 billing pads the product segment with a zero
This package
Contains3-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1319/unit — full pricing hub ↓
Also comes in: 30 tablets 63187-0841-30 60 tablets 63187-0841-60 90 tablets 63187-0841-90
Rx only Generic On market Non-controlled
🗂️ 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 →

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 Spironolactone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 5, 2025 — Presence of foreign substance: identified as aluminum. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0574-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63187-841-03
Product NDC 63187-841
11-digit billing NDC 63187084103
NCPDP billing unit EA — each (per item)
RxCUI 313096
UNII 27O7W4T232
UPC 0363187841300
Application # ANDA203253
SPL Set ID 5c2ae130-8e84-4c3f-b190-82691312fcbd
Established class (EPC) Aldosterone Antagonist
Mechanism of action Aldosterone Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-02-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance SPIRONOLACTONE
GPI-14 37500020000305
GPI class Spironolactone
GCN Seq No 006817
GCN 27691
HICL code 002901
Ingredient (HICL) Spironolactone
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1H
Therapeutic class — specific (HIC3) Potassium Sparing Diuretics
AHFS code 24:32.20.08
AHFS class Steroidal Mineralocorticoid Receptor Ant
FDB label name SPIRONOLACTONE 25 MG TABLET
FDB brand name Spironolactone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63187-841-03 — 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 → 63187-0841-03. 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.

🏷️ RxNorm drug class

This medicine belongs to the Aldosterone Antagonist class.

Pharmacologic class Aldosterone Antagonist
Drug family (ATC) Aldosterone antagonists
How it works Aldosterone Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderJUBILANT GENERICS LTD
FDA applicationANDA203253 (ANDA)
Labeler code63187
First marketedFeb 2013
Product typeHuman Prescription Drug
Portfolio1,723 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 SPIRONOLACTONE 25 MG TABLET Ingredient Spironolactone
📖 What it is MedlinePlus · NLM

Spironolactone is used to treat certain patients with hyperaldosteronism (the body produces too much aldosterone, a naturally occurring hormone); low potassium levels; heart failure; and in patients with edema (fluid retention) caused by various conditions, including liver, or kidney disease. It is also used alone or with other medications to treat high blood pressure. Spironolactone is in a class of medications called aldosterone receptor antagonists. It causes the kidneys to eliminate unneeded water and sodium from the body into the urine but reduces the loss of potassium from the body. High...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Spironolactone has a few different uses depending on your situation. Most commonly, it's prescribed to treat moderate-to-severe heart failure, high blood pressure, or fluid buildup...
  • What exactly is spironolactone used for?
  • Yes, it actually matters quite a bit. Food can nearly double the amount of spironolactone your body absorbs. That doesn't mean you must always take it with food — but you should pi...
  • Does it matter if I take it with food or not?
📖 Read our full Spironolactone guide →
7
Nutrient depletion considerations

Spironolactone may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Spironolactone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

💊 What it looks like

Color Brown
ShapeRound
ImprintTL216
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4846Q921YM
    Calcium sulfate dihydrate is a white, crystalline mineral salt. It works as a filler and binder in tablets and capsules, helping give them structure and hold ingredients together.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII V95R5KMY2B
    Peppermint is a flavoring agent derived from the peppermint plant. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 · Q2 2026 $0.1319 $0.40 / 3 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
Spironolactone 25 mg 00378-2146-01 Mylan 100 tablets $0.043 AB Availability likely —
spironolactone 25 mg 00904-6927-61 Major 100 tablets $0.043 AB Availability likely —
spironolactone 25 mg 31722-0094-01 Camber 100 tablets $0.043 AB Availability likely —
Spironolactone 25 mg 51079-0103-20 Mylan 1 tablet $0.043 AB Availability likely —
Spironolactone 25 mg 53489-0143-01 Sun 100 tablets $0.043 AB Availability likely —
Spironolactone 25 mg 53746-0511-01 Amneal 100 tablets $0.043 AB Availability likely —
Spironolactone 25 mg 59651-0426-01 Aurobindo 100 tablets $0.043 AB Availability likely —
Spironolactone 25 mg 60687-0465-01 American 100 tablets $0.043 AB Availability likely —
Spironolactone 25 mg 64980-0706-01 Rising 100 tablets $0.043 AB Availability likely —
spironolactone 25 mg 68382-0660-01 Zydus 100 tablets $0.043 AB Availability likely —
Spironolactone 25 mg 69584-0852-10 Oxford 100 tablets $0.043 AB Availability likely —
Spironolactone 25 mg 72603-0134-01 NorthStar 100 tablets $0.043 AB Availability likely —
Spironolactone 25 mg 16729-0225-01 Accord 100 tablets $0.045 AB Availability likely —
Spironolactone 25 mg 59746-0216-01 Jubilant 100 tablets $0.052 AB FDA listed —
Aldactone 25 mg 00025-1001-31 Pfizer 100 tablets — AB FDA listed —
Spironolactone 25 mg 00615-8451-05 NCS 15 tablets — AB FDA listed —
Spironolactone 25 mg 42708-0101-30 QPharma, 30 tablets — AB FDA listed —
Spironolactone 25 mg 42708-0126-30 QPharma, 30 tablets — AB FDA listed —
Spironolactone 25 mg 43063-0832-01 PD-Rx 100 tablets — AB FDA listed —
Spironolactone 25 mg 48433-0087-20 Safecor 1 tablet — AB FDA listed —
Spironolactone 25 mg 50090-0136-00 A-S 100 tablets — AB FDA listed —
Spironolactone 25 mg 50090-3747-00 A-S 100 tablets — AB FDA listed —
Spironolactone 25 mg 50090-6369-00 A-S 100 tablets — AB FDA listed —
Spironolactone 25 mg 50090-6908-00 A-S 100 tablets — AB FDA listed —
Spironolactone 25 mg 50090-6909-00 A-S 90 tablets — AB FDA listed —
Spironolactone 25 mg 50090-7797-00 A-S 90 tablets — AB FDA listed —
spironolactone 25 mg 55154-3556-00 Cardinal 10 tablets — AB FDA listed —
Spironolactone 25 mg 55154-5517-00 Cardinal 1 tablet — AB FDA listed —
Spironolactone 25 mgthis 63187-0841-03 Proficient 3 tablets — AB FDA listed —
Spironolactone 25 mg 63629-1061-01 Bryant 100 tablets — AB FDA listed —
Spironolactone 25 mg 63629-1062-01 Bryant 500 tablets — AB FDA listed —
Spironolactone 25 mg 63629-1064-01 Bryant 30 tablets — AB FDA listed —
Spironolactone 25 mg 63629-1830-01 Bryant 30 tablets — AB FDA listed —
Spironolactone 25 mg 63629-2437-01 Bryant 500 tablets — AB FDA listed —
Spironolactone 25 mg 63629-8539-01 Bryant 1000 tablets — AB FDA listed —
Spironolactone 25 mg 65162-0511-03 Amneal 30 tablets — AB FDA listed —
Spironolactone 25 mg 67046-0744-03 Coupler 30 tablets — AB FDA listed —
Spironolactone 25 mg 67544-0310-30 Aphena 30 tablets — AB FDA listed —
Spironolactone 25 mg 68071-2989-03 NuCare 30 tablets — AB FDA listed —
Spironolactone 25 mg 68071-3375-01 NuCare 120 tablets — AB FDA listed —
Spironolactone 25 mg 68071-3967-03 NuCare 30 tablets — AB FDA listed —
Spironolactone 25 mg 68071-3969-01 NuCare 100 tablets — AB FDA listed —
Spironolactone 25 mg 68788-8545-03 Preferred 30 tablets — AB FDA listed —
Spironolactone 25 mg 70518-3625-00 REMEDYREPACK 30 tablets — AB FDA listed —
Spironolactone 25 mg 70518-4350-00 REMEDYREPACK 100 tablets — AB FDA listed —
spironolactone 25 mg 70518-4470-00 REMEDYREPACK 1 tablet — AB FDA listed —
spironolactone 25 mg 70771-1027-00 Zydus 1000 tablets — AB FDA listed —
Spironolactone 25 mg 71205-0146-30 Proficient 30 tablets — AB FDA listed —
Spironolactone 25 mg 71205-0772-30 Proficient 30 tablets — AB FDA listed —
Spironolactone 25 mg 71335-0053-01 Bryant 30 tablets — AB FDA listed —
Spironolactone 25 mg 71335-2205-01 Bryant 500 tablets — AB FDA listed —
Spironolactone 25 mg 71335-2217-01 Bryant 1000 tablets — AB FDA listed —
Spironolactone 25 mg 71335-2301-01 Bryant 1000 tablets — AB FDA listed —
Spironolactone 25 mg 71335-2366-01 Bryant 30 tablets — AB FDA listed —
Spironolactone 25 mg 71335-2846-01 Bryant 100 tablets — AB FDA listed —
Spironolactone 25 mg 71610-0102-60 Aphena 90 tablets — AB FDA listed —
Spironolactone 25 mg 71610-0742-30 Aphena 30 tablets — AB FDA listed —
Spironolactone 25 mg 71610-0970-30 Aphena 30 tablets — AB FDA listed —
Spironolactone 25 mg 72162-1624-01 Bryant 100 tablets — AB FDA listed —
Spironolactone 25 mg 72162-1693-05 Bryant 500 tablets — AB FDA listed —
Spironolactone 25 mg 72162-2150-05 Bryant 500 tablets — AB FDA listed —
Spironolactone 25 mg 72189-0497-90 Direct_Rx 90 tablets — AB FDA listed —
Spironolactone 25 mg 72789-0290-30 PD-Rx 30 tablets — AB FDA listed —
Spironolactone 25 mg 76420-0062-30 Asclemed 30 tablets — AB FDA listed —
Spironolactone 25 mg 76420-0556-01 Asclemed 100 tablets — AB FDA listed —
Spironolactone 25 mg 76420-0925-00 Asclemed 1000 tablets — AB FDA listed —
Spironolactone 25 mg 82804-0255-30 Proficient 30 tablets — AB FDA listed —
Spironolactone 25 mg 82804-0975-00 Proficient 100 tablets — AB FDA listed —
spironolactone 25 mg 51655-0636-26 Northwind 90 tablets — AB FDA listed —
Spironolactone 25 mg 67296-2319-09 Redpharm 90 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

🏛️
2013
On the market since
Feb 2013
📍
2026
Currently FDA-listed
13 years listed
🔓
·
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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Spironolactone — the program that covers self-administered drugs. 15 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Spironolactone. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$23.96M
Claims incl. refills
2.6M
Beneficiaries
1.9M
Spend / beneficiary
$12.45
Spend / claim
$9.09
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63187-0841-03 You're viewing this 3 TABLET, FILM COATED in 1 BOTTLE (63187-841-03) 2017-05-01 Active
63187-0841-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-841-30) 2017-05-01 Active
63187-0841-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-841-60) 2017-05-01 Active
63187-0841-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-841-90) 2017-05-01 Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0841-03?
NDC 63187-0841-03 is a 3-count package — 3 tablet, film coated in 1 bottle.
What is the difference between NDC 63187-0841-03 and NDC 63187-0841-30?
Both are Spironolactone 25 mg Tablet, Film Coated — the drug itself is identical. NDC 63187-0841-03 is the 3-count package, while NDC 63187-0841-30 is the 30 tablets package.
What NDC number is used to bill for this package of Spironolactone 25 mg Tablet, Film Coated?
Bill NDC 63187-0841-03 — the 11-digit billing format is 63187084103. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Inactive ingredients (structured) ✓ 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 ✓ Available
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.
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 63187-841-03, 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: 63187-0841-03, written without dashes as 63187084103. 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 63187-0841-03, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0841) 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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (63187-0841-30), 60 tablets (63187-0841-60), 90 tablets (63187-0841-90). 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?
Proficient Rx LP 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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug / Laboratory Test Interactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 40 words ▾

WARNING Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions ). Spironolactone should be used only in those conditions described under Indications and Usage . Unnecessary use of this drug should be avoided.

🎯 Indications and Usage ~3 min read ▾

INDICATIONS AND USAGE Spironolactone tablets are indicated in the management of: Primary hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery.

Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with: Congestive heart failure : For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Spironolactone tablets are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate.

Cirrhosis of the liver accompanied by edema and/or ascites : Aldosterone levels may be exceptionally high in this condition. Spironolactone tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. Nephrotic syndrome : For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.

Essential hypertension Spironolactone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Usually in combination with other drugs, spironolactone tablets are indicated for patients who cannot be treated adequately with other agents or for whom other agents are consi…

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Primary hyperaldosteronism. Spironolactone tablets may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets. Long test: Spironolactone tablets are administered at a daily dosage of 400 mg for three to four weeks.

Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism. Short test: Spironolactone tablets are administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone tablets administration but drops when spironolactone tablets are discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.

After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone tablets may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone tablets may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient. Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome).

An initial daily dosage of 100 mg of spironolactone tablets administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, spironolactone tablets should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone tablets have not occurred, a second diuretic that acts more proximally in the renal tubule may be added to the regimen.

Because of the additive effect of spironolactone tablets when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone tablets should remain unchanged when other diuretic therapy is added. Essential hypertension.

For adults, an initial daily dosage of 50 to 100 mg of spironolactone tablets administered in either single or divided doses is recommended. Spironolactone tablets may also be given with diuretics that act more proximally in the renal tubule or with other antihypertensive agents. Treatment with spironolactone tablets should be continued for at least two weeks since the maximum response may not occur before this time.

Subsequently, dosage should be adjusted according to the response of the patient. Hypokalemia. Spironolactone tablets in a dosage ranging from 25 mg to 100 mg daily are useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.

Severe heart failure in conjunction with standard therapy (NYHA class III - IV). Treatment should be initiated with spironolactone 25 mg once daily if the patient’s serum potassium is ≤5.0 mEq/L and the patient’s serum creatinine is ≤ 2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated.

Patients who do not tolerate 25 mg once daily may have their dosage reduced to 25 mg every other day. See Warnings: Hyperkalemia in patients with severe heart failure for advice on monitoring serum potassium and serum creatinine.

⛔ Contraindications 27 words ▾

CONTRAINDICATIONS Spironolactone tablets are contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hyperkalemia, Addison’s disease, and with concomitant use of eplerenone.

⚠️ Warnings ~2 min read ▾

WARNINGS Potassium supplementation. Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with spironolactone therapy. Excessive potassium intake may cause hyperkalemia in patients receiving spironolactone ( see Precautions: General ).

Concomitant administration of spironolactone with the following drugs or potassium sources may lead to severe hyperkalemia: • other potassium-sparing diuretics • ACE inhibitors • angiotensin II antagonists • aldosterone blockers • non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin • heparin and low molecular weight heparin • other drugs or conditions known to cause hyperkalemia • potassium supplements • diet rich in potassium • salt substitutes containing potassium Spironolactone should not be administered concurrently with other potassium-sparing diuretics.

Spironolactone tablets, when used with ACE inhibitors or indomethacin, even in the presence of a diuretic, has been associated with severe hyperkalemia. Extreme caution should be exercised when spironolactone is given concomitantly with these drugs. Hyperkalemia in patients with severe heart failure.

Hyperkalemia may be fatal. It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Avoid using other potassium-sparing diuretics.

Avoid using oral potassium supplements in patients with serum potassium > 3.5 mEq/L. The Randomized Spironolactone Evaluation Study excluded patients with a serum creatinine > 2.5 mg/dL or a recent increase in serum creatinine >25%. The recommended monitoring for potassium and creatinine is one week after initiation or increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months.

Discontinue or interrupt treatment for serum potassium > 5 mEq/L or for serum creatinine > 4 mg/dL. ( Error! Hyperlink reference not valid.

Error! Hyperlink reference not valid. , and Error! Hyperlink reference not valid. .) Spironolactone should be used with caution in patients with impaired hepatic function because minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Lithium generally should not be given with diuretics (see Error! Hyperlink reference not valid. ).

🤒 Adverse Reactions 156 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Gynecomastia (see Precautions ), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast pain.

Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established. Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Metabolism: Hyperkalemia, electrolyte disturbances (see Warning s and Precautions ). Musculoskeletal: Leg cramps. Nervous system /psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.

Liver / biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration. Renal: Renal dysfunction (including renal failure). Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis.

🔄 Drug / Laboratory Test Interactions ~2 min read ▾

Drug interactions: ACE inhibitors: Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe hyperkalemia. Angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia: Concomitant administration may lead to severe hyperkalemia. Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.

Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur. Pressor amines (e.g., norepinephrine): Spironolactone reduces the vascular responsiveness to norepinephrine. Therefore, caution should be exercised in the management of patients subjected to regional or general anesthesia while they are being treated with spironolactone.

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): Possible increased responsiveness to the muscle relaxant may result. Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.

Nonsteroidal anti-inflammatory drugs (NSAIDs): In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing, and thiazide diuretics. Combination of NSAIDs, e.g., indomethacin, with potassium-sparing diuretics has been associated with severe hyperkalemia. Therefore, when spironolactone and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

Digoxin: Spironolactone has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. It may be necessary to reduce the maintenance and digitalization doses when spironolactone is administered, and the patient should be carefully monitored to avoid over- or under-digitalization.

Cholestyramine: Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine. Drug/Laboratory test interactions: Several reports of possible interference with digoxin radioimmunoassay by spironolactone, or its metabolites, have appeared in the literature. Neither the extent nor the potential clinical significance of its interference (which may be assay-specific) has been fully established.

Carcinogenesis, mutagenesis, impairment of fertility : Orally administered spironolactone has been shown to be a tumorigen in dietary administration studies performed in rats, with its proliferative effects manifested on endocrine organs and the liver. In an 18-month study using doses of about 50, 150, and 500 mg/kg/day, there were statistically significant increases in benign adenomas of the thyroid and testes and, in male rats, a dose-related increase in proliferative changes in the liver (including hepatocytomegaly and hyperplastic nodules).

In a 24-month study in which the same strain of rat was administered doses of about 10, 30, 100, and 150 mg spironolactone/kg/day, the range of proliferative effects included significant increases in hepatocellular adenomas and testicular interstitial cell tumors in males, and significant increases in thyroid follicular cell adenomas and carcinomas in both sexes. There was also a statistically significant, but not dose-related, increase in benign uterine endometrial stromal polyps in females. A dose-related (above 20 mg/kg/day) incidence of myelocytic leukemia was observed in rats fed daily doses of potassium canrenoate (a compound chemically similar to spironolactone and whose primary metabolite, canrenone, is also a major product of spironolactone in man) for a period of one year.

In two-year studies in the rat, oral administration of potassium canrenoate was associated with myelocytic leukemia and hepatic, thyroid, testicular, and mammary tumors. Neither spironolactone nor potassium canrenoate produced mutagenic effects i…

🆘 Overdosage 179 words ▾

OVERDOSAGE The oral LD 50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits. Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage.

Hyperkalemia may occur, especially in patients with impaired renal function. Treatment: Induce vomiting or evacuate the stomach by lavage. There is no specific antidote.

Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop spironolactone-induced hyperkalemia. In such cases, spironolactone should be discontinued immediately.

With severe hyperkalemia, the clinical situation dictates the procedures to be employed. These may include the intravenous administration of calcium chloride solution, sodium bicarbonate solution and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation. These are temporary measures to be repeated as required.

Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of action: Spironolactone is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.

It may be given alone or with other diuretic agents that act more proximally in the renal tubule. Aldosterone antagonist activity: Increased levels of the mineralocorticoid, aldosterone, are present in primary and secondary hyperaldosteronism. Edematous states in which secondary aldosteronism is usually involved include congestive heart failure, hepatic cirrhosis, and nephrotic syndrome.

By competing with aldosterone for receptor sites, spironolactone provides effective therapy for the edema and ascites in those conditions. Spironolactone counteracts secondary aldosteronism induced by the volume depletion and associated sodium loss caused by active diuretic therapy. Spironolactone is effective in lowering the systolic and diastolic blood pressure in patients with primary hyperaldosteronism.

It is also effective in most cases of essential hypertension, despite the fact that aldosterone secretion may be within normal limits in benign essential hypertension. Through its action in antagonizing the effect of aldosterone, spironolactone inhibits the exchange of sodium for potassium in the distal renal tubule and helps to prevent potassium loss. Spironolactone has not been demonstrated to elevate serum uric acid, to precipitate gout, or to alter carbohydrate metabolism.

Pharmacokinetics: Spironolactone is rapidly and extensively metabolized. Sulfur-containing products are the predominant metabolites and are thought to be primarily responsible, together with spironolactone, for the therapeutic effects of the drug. The following pharmacokinetic data were obtained from 12 healthy volunteers following the administration of 100 mg of spironolactone film-coated tablets daily for 15 days.

On the 15th day, spironolactone was given immediately after a low-fat breakfast and blood was drawn thereafter. Accumulation Factor: AUC (0–24 hr, day 15)/ AUC (0–24 hr, day 1) Mean Peak Serum Concentration Mean (SD) Post Steady- State Half-Life 7-α-(thiomethyl) spirolactone (TMS) 1.25 391 ng/mL at 3.2 hr 13.8 hr (6.4) (terminal) 6-β-hydroxy-7-α-(thiomethyl) spirolactone (HTMS) 1.50 125 ng/mL at 5.1 hr 15.0 hr (4.0) (terminal) Canrenone (C) 1.41 181 ng/mL at 4.3 hr 16.5 hr (6.3) (terminal) Spironolactone 1.30 80 ng/mL at 2.6 hr Approximately 1.4 hr (0.5) (β half-life) The pharmacological activity of spironolactone metabolites in man is not known.

However, in the adrenalectomized rat the antimineralocorticoid activities of the metabolites C, TMS, and HTMS, relative to spironolactone, were 1.10, 1.28, and 0.32, respectively. Relative to spironolactone, their binding affinities to the aldosterone receptors in rat kidney slices were 0.19, 0.86, and 0.06, respectively. In humans, the potencies of TMS and 7-α-thiospirolactone in reversing the effects of the synthetic mineralocorticoid, fludrocortisone, on urinary electrolyte composition were 0.33 and 0.26, respectively, relative to spironolactone.

However, since the serum concentrations of these steroids were not determined, their incomplete absorption and/or first-pass metabolism could not be ruled out as a reason for their reduced in vivo activities. Spironolactone and its metabolites are more than 90% bound to plasma proteins. The metabolites are excreted primarily in the urine and secondarily in bile.

The effect of food on spironolactone absorption (two 100 mg spironolactone tablets) was assessed in a single-dose study of 9 healthy, drug-free volunteers. Food increased the bioavailability of unmetabolized spironolactone by almost 100%. The clinical imp…

📦 How Supplied / Storage and Handling 117 words ▾

HOW SUPPLIED Spironolactone Tablets, USP 25 mg are brown colored, round, biconvex, film-coated tablets debossed with 'TL 216' on one side and plain on the other side. Bottle of 3 Tablets NDC 63187-841-03 Bottle of 30 Tablets NDC 63187-841-30 Bottle of 60 Tablets NDC 63187-841-60 Bottle of 90 Tablets NDC 63187-841-90 For more information, call 1-800-313-4623. Protect from light.

Dispense in tight, light-resistant, child resistant container as defined in the USP. Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature]. Rx Only Manufactured by: Jubilant Generics Limited Roorkee - 247661, India Marketed by: Jubilant Cadista Pharmaceuticals Inc.

Salisbury, MD 21801, USA Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: February/2015

📋 Description 87 words ▾

DESCRIPTION Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: Spironolactone USP is freely soluble in benzene and chloroform; soluble in ethyl acetate and in alcohol, slightly soluble in ether, in methanol and in fixed oils and practically insoluble in water. Inactive ingredients include calcium sulfate dihydrate, corn starch, peppermint, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide, iron oxide red, iron oxide yellow and iron oxide black.

Spironolactone Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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