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Spironolactone 100 mg Tablet, 90-count — NDC 71335-0966-04 package photo

Spironolactone 100 mg Tablet, 90-count

by Bryant Ranch Prepack · 90 TABLET in 1 BOTTLE (71335-0966-4)
NDC 71335-0966-04
🏷️ FDA NDC (as labeled) 71335-0966-4 billing pads the package segment with a zero
This package
Contains90-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.1319/unit — full pricing hub ↓
Also comes in: 3 tablets 71335-0966-02 30 tablets 71335-0966-03 60 tablets 71335-0966-05 100 tablets 71335-0966-01
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) 71335-0966-4
Product NDC 71335-0966
11-digit billing NDC 71335096604
RxCUI 198222
UNII 27O7W4T232
Application # ANDA091426
SPL Set ID 31aeab13-8f71-49f1-b101-8b0abb21b0dc
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 2010-08-02
Route ORAL
Dosage form TABLET
Substance SPIRONOLACTONE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-0966-4 — a 5-4-1 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 package segment → 71335-0966-04. 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

LabelerBryant Ranch Prepack
Application holderAMNEAL PHARMACEUTICALS OF NEW YORK LLC
FDA applicationANDA091426 (ANDA)
Labeler code71335
First marketedAug 2010
Product typeHuman Prescription Drug
Portfolio4,433 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

📗 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
ImprintAN;515
Size11 mm
ScoringScored — splits in 2
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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine 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 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

14 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 $11.87 / 90 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 100 mg 00378-0437-01 Mylan 100 tablets $0.170 AB Availability likely —
spironolactone 100 mg 31722-0096-01 Camber 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 51079-0980-08 Mylan 1 tablet $0.170 AB Availability likely —
Spironolactone 100 mg 53489-0329-01 Sun 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 53746-0515-01 Amneal 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 59651-0428-01 Aurobindo 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 59746-0218-01 Jubilant 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 60687-0487-01 American 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 64980-0708-01 Rising 100 tablets $0.170 AB Availability likely —
spironolactone 100 mg 68382-0662-01 Zydus 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 69584-0854-10 Oxford 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 72603-0136-01 NorthStar 100 tablets $0.170 AB Availability likely —
Spironolactone 100 mg 16729-0227-01 Accord 100 tablets $0.178 AB Availability likely —
Aldactone 100 mg 00025-1031-31 Pfizer 100 tablets — AB FDA listed —
Spironolactone 100 mg 43063-0835-30 PD-Rx 30 tablets — AB FDA listed —
Spironolactone 100 mg 48433-0089-08 Safecor 1 tablet — AB FDA listed —
Spironolactone 100 mg 50090-6432-00 A-S 90 tablets — AB FDA listed —
Spironolactone 100 mg 50090-6539-00 A-S 90 tablets — AB FDA listed —
spironolactone 100 mg 51655-0153-26 Northwind 90 tablets — AB FDA listed —
Spironolactone 100 mg 51655-0344-26 Northwind 90 tablets — AB FDA listed —
Spironolactone 100 mg 63629-1092-01 Bryant 100 tablets — AB FDA listed —
Spironolactone 100 mg 63629-1093-01 Bryant 30 tablets — AB Discontinued —
Spironolactone 100 mg 63629-1094-01 Bryant 500 tablets — AB FDA listed —
Spironolactone 100 mg 63629-4094-01 Bryant 100 tablets — AB FDA listed —
Spironolactone 100 mg 65162-0515-03 Amneal 30 tablets — AB FDA listed —
Spironolactone 100 mg 67046-1636-03 Coupler 30 tablets — AB FDA listed —
Spironolactone 100 mg 68071-2988-03 NuCare 30 tablets — AB FDA listed —
Spironolactone 100 mg 68788-8381-03 Preferred 30 tablets — AB FDA listed —
Spironolactone 100 mg 70518-0665-01 REMEDYREPACK 30 tablets — AB FDA listed —
Spironolactone 100 mg 70518-3721-00 REMEDYREPACK 30 tablets — AB FDA listed —
Spironolactone 100 mg 70518-4447-00 REMEDYREPACK 100 tablets — AB FDA listed —
spironolactone 100 mg 70518-4512-00 REMEDYREPACK 1 tablet — AB FDA listed —
spironolactone 100 mg 70771-1029-00 Zydus 1000 tablets — AB FDA listed —
Spironolactone 100 mg 71205-0148-30 Proficient 30 tablets — AB FDA listed —
Spironolactone 100 mg 71335-0304-01 Bryant 100 tablets — AB Discontinued —
Spironolactone 100 mgthis 71335-0966-04 Bryant 90 tablets — AB FDA listed —
Spironolactone 100 mg 71335-2203-01 Bryant 500 tablets — AB FDA listed —
Spironolactone 100 mg 71335-2204-01 Bryant 100 tablets — AB FDA listed —
Spironolactone 100 mg 71610-0288-30 Aphena 30 tablets — AB FDA listed —
Spironolactone 100 mg 72162-1627-02 Bryant 100 tablets — AB FDA listed —
Spironolactone 100 mg 72189-0495-90 Direct_Rx 90 tablets — AB FDA listed —
Spironolactone 100 mg 72789-0292-30 PD-Rx 30 tablets — AB FDA listed —
Spironolactone 100 mg 76420-0558-01 Asclemed 100 tablets — AB FDA listed —
Spironolactone 100 mg 76420-0927-00 Asclemed 1000 tablets — AB FDA listed —
Spironolactone 100 mg 82804-0205-30 Proficient 30 tablets — AB FDA listed —
Spironolactone 100 mg 82804-0977-00 Proficient 100 tablets — AB FDA listed —
Spironolactone 100 mg 68788-4188-03 Preferred 30 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

🏛️
2010
On the market since
Aug 2010
📍
2026
Currently FDA-listed
16 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
71335-0966-01 100 TABLET in 1 BOTTLE (71335-0966-1) 2021-12-28 Active
71335-0966-02 3 TABLET in 1 BOTTLE (71335-0966-2) 2021-12-28 Active
71335-0966-03 30 TABLET in 1 BOTTLE (71335-0966-3) 2018-10-09 Active
71335-0966-04 You're viewing this 90 TABLET in 1 BOTTLE (71335-0966-4) 2021-12-28 Active
71335-0966-05 60 TABLET in 1 BOTTLE (71335-0966-5) 2021-12-28 Active

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

Pack size FAQ

What quantity is in NDC 71335-0966-04?
NDC 71335-0966-04 is a 90-count package — 90 tablet in 1 bottle.
What is the difference between NDC 71335-0966-04 and NDC 71335-0966-02?
Both are Spironolactone 100 mg Tablet — the drug itself is identical. NDC 71335-0966-04 is the 90-count package, while NDC 71335-0966-02 is the 3 tablets package.
What NDC number is used to bill for this package of Spironolactone 100 mg Tablet?
Bill NDC 71335-0966-04 — the 11-digit billing format is 71335096604. 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 71335-0966-4, 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: 71335-0966-04, written without dashes as 71335096604. 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 71335-0966-04, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (0966) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Bryant Ranch Prepack. 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 4 other package presentations of this same product, including 3 tablets (71335-0966-02), 30 tablets (71335-0966-03), 60 tablets (71335-0966-05). 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?
Bryant Ranch Prepack 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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Spironolactone tablets are an aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. ( 1.1 ) Use as an add-on therapy 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.

( 1.2 ) The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response. ( 1.3 ) Treatment of primary hyperaldosternism for: ( 1.4 ) Short-term preoperative treatment. Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.

1.1Heart Failure Spironolactone tablets are indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. Spironolactone tablets are usually administered in conjunction with other heart failure therapies.

1.2Hypertension Spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. 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.

1.3 Edema Associated with Hepatic Cirrhosis or Nephro…

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Heart Failure: Initiate treatment at 25 mg once daily. ( 2.2 ) Hypertension: Initiate treatment at 25 mg to 100 mg daily in either single or divided doses. ( 2.3 ) Edema: Initiate therapy in a hospital setting and titrate slowly.

The recommended initial daily dose is 100 mg in single or divided doses. ( 2.4 ) Primary hyperaldosteronism: Initiate treatment at 100 mg to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient.

( 2.5 )

2.1General Considerations Spironolactone tablets can be taken with or without food, but should be taken consistently with respect to food [see Clinical Pharmacology (12.3) ] .

2.2Treatment of Heart Failure In patients with serum potassium ≤ 5.0 mEq/L and eGFR > 50 mL/min/1.73 m 2 , initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Warnings and Precautions (5.1) ] .

In patients with an eGFR between 30 and 50 mL/min/1.73 m 2 , consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [see Use in Specific Populations (8.6) ].

2.3Treatment of Essential Hypertension The recommended initial daily dose is 25 mg to 100 mg of spironolactone tablets administered in either single or divided doses is recommended. Dosage can be titrated at two-week intervals. Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure.

2.4Treatment of Edema In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly [see Use in Specific Populations (8.7) ] . The recommended initial daily dosage is 100 mg of spironolactone tablets administered in either single or divided doses, but may range from 25 mg to 200 mg daily. When given as the sole agent for diuresis, administer for at least five days before increasing dose to obtain desired effect.

2.5Treatment of Primary Hyperaldosteronism Administer spironolactone tablets in doses of 100 mg to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone tablets can be used as long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

💊 Dosage Forms and Strengths 82 words ▾

3 DOSAGE FORMS AND STRENGTHS Spironolactone Tablets USP, 25 mg are white, film-coated, round tablets, debossed “AN” above “511” on one side and plain on other side. Spironolactone Tablets USP, 50 mg are yellow, film-coated, round tablets, debossed “AN” bisect “514” on one side and plain on other side. Spironolactone Tablets USP, 100 mg are beige, film-coated, round tablets, debossed “AN” bisect “515” on one side and plain on other side.

Tablets: 25 mg, 50 mg, and 100 mg. ( 3 )

⛔ Contraindications 32 words ▾

4 CONTRAINDICATIONS Spironolactone is contraindicated in the patients with: Hyperkalemia Addison’s disease Concomitant use of eplerenone Spironolactone is contraindicated in patients with ( 4 ): Hyperkalemia Addison’s disease Concomitant use of eplerenone

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter. ( 5.1 ) Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically. ( 5.2 ) Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically. ( 5.3 ) Gynecomastia: Spironolactone can cause gynecomastia. ( 5.4 )

5.1Hyperkalemia Spironolactone can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers [see Drug Interactions (7.1) ] . Monitor serum potassium within 1 week of initiation or titration of spironolactone and regularly thereafter.

More frequent monitoring may be needed when spironolactone is given with other drugs that cause hyperkalemia or in patients with impaired renal function. If hyperkalemia occurs, decrease the dose or discontinue spironolactone and treat hyperkalemia.

5.2Hypotension and Worsening Renal Function Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically.

5.3Electrolyte and Metabolic Abnormalities In addition to causing hyperkalemia, spironolactone can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia. Asymptomatic hyperuricemia can occur and rarely gout is precipitated. Monitor serum electrolytes, uric acid and blood glucose periodically.

5.4Gynecomastia Spironolactone can cause gynecomastia. In a Randomized Spironolactone Evaluation Study, patients with heart failure treated with a mean dose of 26 mg of spironolactone once daily, about 9% of the male subjects developed gynecomastia. The risk of gynecomastia increases in a dose-dependent manner with an onset that varies widely from 1 to 2 months to over a year. Gynecomastia is usually reversible.

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions ( 5.1 )]. Hypotension and Worsening Renal Function [see Warnings and Precautions ( 5.2 )]. Electrolyte and Metabolic Abnormalities [see Warnings and Precautions ( 5.3 )].

Gynecomastia [see Warnings and Precautions ( 5.4 )]. Impaired neurological function/coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations (8.7) ]. The following adverse reactions associated with the use of spironolactone were identified in clinical trials or post-marketing reports.

Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain.

Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Metabolism: Hyperkalemia, electrolyte disturbances [see Warnings and Precautions ( 5.1 , 5.3 )] , hyponatremia, hypovolemia.

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, pruritus. The most common adverse reaction with spironolactone treatment is gynecomastia.

( 5.4 , 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia. ( 5.1 , 7.1 ) Lithium: Increased risk of lithium toxicity. ( 7.2 ) NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone.

( 7.3 ) Digoxin: Spironolactone can interfere with radioimmunologic assays of digoxin exposure. ( 7.4) Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use. ( 7.5 ) Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone.

( 7.6 ) Abiraterone: May increase prostate-specific antigen (PSA) levels. (7.7)

7.1Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia. In general, discontinue potassium supplementation in heart failure patients who start spironolactone [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] . Check serum potassium levels when ACE inhibitor or ARB therapy is altered in patients receiving spironolactone.

Examples of drugs that can increase potassium include: ACE inhibitors angiotensin receptor blockers non-steroidal anti-inflammatory drugs (NSAIDs) heparin and low molecular weight heparin trimethoprim

7.2Lithium Like other diuretics, spironolactone reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when spironolactone is co-administered [see Clinical Pharmacology (12.3) ] .

7.3Nonsteroidal anti-inflammatory drugs (NSAIDs) In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of diuretics. Therefore, when spironolactone and NSAIDs are used concomitantly, monitor closely to determine if the desired effect of the diuretic is obtained [see Clinical Pharmacology (12.3) ] .

7.4Digoxin Spironolactone and its metabolites interfere with radioimmunoassays for digoxin and increase the apparent exposure to digoxin. It is unknown to what extent, if any, spironolactone may increase actual digoxin exposure. In patients taking concomitant digoxin, use an assay that does not interact with spironolactone.

7.5Cholestyramine Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine.

7.6Acetylsalicylic Acid Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when spironolactone and acetylsalicylic acid are used concomitantly, spironolactone may need to be titrated to higher maintenance dose and the patient should be observed closely to determine if the desired effect is obtained [see Clinical Pharmacology (12.3) ] .

7.7Abiraterone Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Concomitant use of spironolactone and abiraterone is not recommended.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, spironolactone may affect sex differentiation of the male during embryogenesis. ( 8.1 )

8.1Pregnancy Risk Summary Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis ( see Data) . Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero . Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone .

There are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy ( see Clinical Considerations) . Because of the potential risk to the male fetus due to anti-androgenic properties of spironolactone and animal data, avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with congestive heart failure are at increased risk for preterm birth.

Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death. Closely monitor pregnant patients for destabilization of their heart failure.

Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices. Pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly.

Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Data Animal Data Teratology studies with spironolactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day.

On a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose. No teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. Because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, spironolactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis.

When administered to rats at 200 mg/kg/day between gestation days 13 and 21 (late embryogenesis and fetal development), feminization of male fetuses was observed. Offspring exposed during late pregnancy to 50 mg/kg/day and 100 mg/kg/day doses of spironolactone exhibited changes in the reproductive tract including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction, that persisted into adulthood.

Spironolactone has known endocrine effects in animals including progestational and antiandrogenic effects.

8.2Lactation Risk Summary Spironolactone is not present in breast milk; however, limited data from a lactating woman at 17 days postpartum reports t…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis ( see Data) . Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero . Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone .

There are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy ( see Clinical Considerations) . Because of the potential risk to the male fetus due to anti-androgenic properties of spironolactone and animal data, avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with congestive heart failure are at increased risk for preterm birth.

Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death. Closely monitor pregnant patients for destabilization of their heart failure.

Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices. Pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly.

Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Data Animal Data Teratology studies with spironolactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day.

On a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose. No teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. Because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, spironolactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis.

When administered to rats at 200 mg/kg/day between gestation days 13 and 21 (late embryogenesis and fetal development), feminization of male fetuses was observed. Offspring exposed during late pregnancy to 50 mg/kg/day and 100 mg/kg/day doses of spironolactone exhibited changes in the reproductive tract including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction, that persisted into adulthood.

Spironolactone has known endocrine effects in animals including progestational and antiandrogenic effects.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 42 words ▾

8.5Geriatric Use Spironolactone is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, monitor renal function.

🆘 Overdosage 110 words ▾

10 OVERDOSAGE The oral LD 50 of spironolactone is greater than 1,000 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 hyperkalemia. In such cases, discontinue spironolactone.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Spironolactone and its active metabolites are specific pharmacologic antagonists 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.

12.2Pharmacodynamics 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.

12.3Pharmacokinetics Absorption The mean time to reach peak plasma concentration of spironolactone and the active metabolite, canrenone, in healthy volunteers is 2.6 and 4.3 hours, respectively. Effect of food: Food increased the bioavailability of spironolactone (as measured by AUC) by approximately 95.4%. Patients should establish a routine pattern for taking spironolactone with regard to meals [see Dosage and Administration (2.1) ] .

Distribution Spironolactone and its metabolites are more than 90% bound to plasma proteins. Elimination The mean half-life of spironolactone is 1.4 hour. The mean half-life values of its metabolites including canrenone, 7-α-(thiomethyl) spironolactone (TMS), and 6-ß-hydroxy-7-α-(thiomethyl) spironolactone (HTMS) are 16.5, 13.8, and 15 hours, respectively.

Metabolism: Spironolactone is rapidly and extensively metabolized. Metabolites can be divided into two main categories: those in which sulfur of the parent molecule is removed (e.g., canrenone) and those in which the sulfur is retained (e.g., TMS and HTMS). In humans, the potencies of TMS and 7-α-thiospironolactone in reversing the effects of the synthetic mineralocorticoid, fludrocortisone, on urinary electrolyte composition were approximately a third 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. Excretion: The metabolites are excreted primarily in the urine and secondarily in bile. Specific Populations The impact of age, sex, race/ethnicity, and renal impairment on the pharmacokinetics of spironolactone have not been specifically studied.

Patients with Hepatic Impairment: The terminal half-life of spironolactone has been reported to be increased in patients with cirrhotic ascites [see Use in Specific Populations (8.7) ] . Drug Interaction Studies : Drugs and Supplements Increasing Serum Potassium: Concomitant administration of spironolactone with potassium supplementation, salt substitutes containing potassium, a diet rich in potassium, or drugs that can increase potassium, including ACE inhibitors, angiotensin II antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), heparin and low molecular weight heparin, may lead to severe hyperkalemia [see Warnings and Precautions (5.1) and Drug Interactions (7.1) ] .

Lithium: Spironolactone reduces the renal clearance of lithium, inducing a high risk of lithium toxicity [see Drug Interactions (7.2) ] . 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 [see Drug Interactions…

🧬 Mechanism of Action 81 words ▾

12.1Mechanism of Action Spironolactone and its active metabolites are specific pharmacologic antagonists 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.

📦 How Supplied / Storage and Handling 97 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Spironolactone Tablets USP, 100 mg are beige, film-coated, round tablets, debossed “AN” bisect “515” on one side and plain on other side. They are available as follows: NDC 71335-0966-1: 100 Tablets in a BOTTLE NDC 71335-0966-2: 3 Tablets in a BOTTLE NDC 71335-0966-3: 30 Tablets in a BOTTLE NDC 71335-0966-4: 90 Tablets in a BOTTLE NDC 71335-0966-5: 60 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Protect from light. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 91 words ▾

11 DESCRIPTION Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, USP 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 practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, corn starch, croscarmellose sodium, peppermint flavor, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and triacetin.

The 50 mg tablet also contains D&C yellow # 10 and FD&C yellow # 6.

💬 Information for Patients 59 words ▾

17 PATIENT COUNSELING INFORMATION Patients who receive spironolactone should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes. This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com.

Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

07-2024-07

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-0964-01 · Bryant 71335-0967-01 · Bryant →
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.