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Potassium Chloride 750 mg Tablet, Film Coated, Extended Release, 540-count — NDC 71610-0349-98 package photo

Potassium Chloride 750 mg Tablet, Film Coated, Extended Release, 540-count

by Aphena Pharma Solutions - Tennessee, LLC · 540 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-98)
NDC 71610-0349-98
🏷️ FDA NDC (as labeled) 71610-349-98 billing pads the product segment with a zero
This package
Contains540-count Pack sizes11 compare ↓
Also priced by: Part D plans $0.1839/unit — full pricing hub ↓
Also comes in: 15 tablets 71610-0349-15 30 tablets 71610-0349-30 45 tablets 71610-0349-45 60 tablets 71610-0349-53 90 tablets 71610-0349-60 120 tablets 71610-0349-70 180 tablets 71610-0349-80 200 tablets 71610-0349-85 270 tablets 71610-0349-92 360 tablets 71610-0349-94
Rx only Brand 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 Potassium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Oct 29, 2025 — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq (Otsuka ICU Medical LLC) · FDA recall D-0181-2026
Class I · Oct 29, 2025 — Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq (Otsuka ICU Medical LLC) · FDA recall D-0180-2026
Class I · Feb 13, 2025 — Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq (ICU Medical, Inc.) · FDA recall D-0268-2025
Class I · Feb 13, 2025 — Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container. (ICU Medical, Inc.) · FDA recall D-0267-2025
Class II · Jan 30, 2025 — Failed Dissolution Specifications. (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) · FDA recall D-0221-2025
Class I · Jun 25, 2024 — Failed Dissolution Specifications (Amerisource Health Services LLC) · FDA recall D-0619-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71610-349-98
Product NDC 71610-349
11-digit billing NDC 71610034998
NCPDP billing unit EA — each (per item)
RxCUI 628953
UNII 660YQ98I10
Application # NDA019123
SPL Set ID 81a53ecd-2612-4efe-9491-415fff3f86e5
Established class (EPC) Osmotic Laxative; Potassium Salt
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
Chemical class Potassium Compounds
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-21
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance POTASSIUM CHLORIDE
GPI-14 79700030000430
GPI class Potassium Chloride ER
GCN Seq No 001275
GCN 03510
HICL code 000549
Ingredient (HICL) Potassium Chloride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1D
Therapeutic class — specific (HIC3) Potassium Replacement
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name POTASSIUM CL ER 10 MEQ TABLET
FDB brand name Potassium Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB2 · RLD · RS
Why two NDCs? The FDA registers this code as 71610-349-98 — 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 → 71610-0349-98. 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 Potassium class.

Drug family (ATC) Potassium, Electrolyte solutions
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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderUPSHER SMITH LABORATORIES LLC
FDA applicationNDA019123 (NDA)
Labeler code71610
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio795 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 POTASSIUM CL ER 10 MEQ TABLET Ingredient Potassium Chloride
📗 Our plain-language guide HelloPharmacist
  • You're right that food is the first line — bananas, potatoes, and leafy greens are all rich in potassium. But sometimes diet alone isn't enough, especially if you're taking a diure...
  • Why did my doctor prescribe potassium chloride? I thought potassium just came from bananas.
  • Yes — always take oral tablets or capsules with a meal or right after eating. Taking them on an empty stomach can irritate or even ulcerate the lining of your stomach or intestines...
  • Do I have to take it with food? What happens if I forget?
📖 Read our full Potassium Chloride guide →
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 yellow
ShapeRound
ImprintKC;10
Size13 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII Z82Y2C65EA
    Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
  • 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 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 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.

9 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 $0.1839 $99.31 / 540 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
Potassium Chloride 10 meq 00378-4561-05 Mylan 500 tablets $0.084 AB2 Availability likely —
Potassium Chloride 750 mg 00832-5323-10 Upsher-Smith 1000 tablets $0.084 AB2 Availability likely —
Potassium Chloride 750 mg 00904-7216-61 Major 1 tablet $0.084 AB2 Availability likely —
Potassium Chloride Extended Release 750 mg 16571-0843-01 Rising 100 tablets $0.084 AB2 Availability likely —
Potassium Chloride Extended-Release 750 mg 24979-0231-01 Upsher-Smith 100 tablets $0.084 AB3 Availability likely —
Potassium Chloride 750 mg 42806-0423-01 Epic 100 tablets $0.084 AB2 Availability likely —
Potassium Chloride 750 mg 60687-0810-09 American 1 tablet $0.084 AB2 Availability likely —
Potassium Chloride 750 mg 64380-0861-06 Strides 100 tablets $0.084 AB2 Availability likely —
Potassium Chloride 750 mg 65862-0987-01 Aurobindo 100 tablets $0.084 AB2 Availability likely —
Potassium Chloride 750 mg 68001-0518-00 BluePoint 100 tablets $0.084 AB2 Availability likely —
Potassium Chloride Extended Release 750 mg 70010-0022-01 Granules 100 tablets $0.084 AB2 Availability likely —
Potassium chloride 750 mg 72888-0075-00 Advagen 1000 tablets $0.084 — Availability likely —
Potassium Chloride 750 mg 70436-0002-01 Slate 100 tablets $0.110 AB2 FDA listed —
Klor-Con 750 mg 00245-0836-11 Upsher-Smith 100 tablets $0.123 AB2 Availability likely —
Klor-Con 750 mg 00245-5316-01 Upsher-Smith 1 tablet $0.123 AB2 Availability likely —
Potassium Chloride Extended-Release 750 mg 63304-0076-01 Sun 100 tablets $0.130 AB1 Availability likely —
potassium chloride 750 mg 68462-0471-01 Glenmark 100 tablets $0.130 AB1 Discontinued —
Potassium Chloride 750 mg 31722-0133-01 Camber 100 tablets $0.130 AB1 Availability likely —
potassium chloride 750 mg 72603-0337-01 Northstar 100 tablets $0.130 AB1 Availability likely —
Potassium Chloride Extended-Release 750 mg 00904-7547-61 Major 1 tablet $0.130 AB1 Availability likely —
Potassium Chloride 750 mg 00832-5324-10 Upsher-SmithLaboratories, 1000 tablets $0.130 AB1 Availability likely —
Potassium Chloride Extended-Release 750 mg 60687-0632-01 American 1 tablet $0.130 AB1 Availability likely —
Potassium Chloride 750 mg 00904-7292-61 Major 1 tablet $0.135 — Discontinued —
Potassium Chloride 750 mg 63739-0972-10 Mckesson 10 tablets $0.150 AB1 Discontinued —
Klor-Con M 750 mg 00245-5317-01 Upsher-Smith 1 tablet $0.157 AB1 Availability likely —
Potassium Chloride 750 mg 00615-8570-05 NCS 15 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 24979-0230-00 Upsher-Smith 64000 tablets — AB2 FDA listed —
Potassium chloride 750 mg 33342-0418-11 Macleods 100 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 42291-0487-01 AvKARE 100 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 42291-0506-01 AvKARE 100 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 50090-5335-00 A-S 30 tablets — AB2 FDA listed —
Potassium Chloride 10 meq 50090-6635-00 A-S 90 tablets — AB2 FDA listed —
Potassium Chloride Extended-Release 750 mg 50090-6639-00 A-S 30 tablets — AB3 FDA listed —
Potassium Chloride Extended-Release 750 mg 50090-6640-00 A-S 90 tablets — AB3 FDA listed —
Potassium Chloride 750 mg 50090-7378-00 A-S 30 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 50090-7379-00 A-S 90 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 50090-7639-00 A-S 30 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 50090-7640-00 A-S 90 tablets — AB2 FDA listed —
Potassium chloride 750 mg 50090-7748-00 A-S 30 tablets — — FDA listed —
Potassium chloride 750 mg 50090-7749-00 A-S 90 tablets — — FDA listed —
Potassium Chloride 750 mg 51655-0226-26 Northwind 90 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 51655-0463-84 Northwind 14 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 51655-0706-52 Northwind 30 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 60760-0423-90 St. 90 tablets — AB2 FDA listed —
Potassium chloride extended release 750 mg 63629-8442-01 Bryant 100 tablets — AB2 Discontinued —
Potassium Chloride 750 mg 68788-8262-03 Preferred 30 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 70436-0152-01 Slate 100 tablets — AB3 FDA listed —
Potassium Chloride 750 mg 70518-2964-00 REMEDYREPACK 30 tablets — AB2 FDA listed —
Potassium Chloride Extended Release 750 mg 70518-4520-00 REMEDYREPACK 30 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 71335-1131-01 Bryant 30 tablets — AB2 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-2447-01 Bryant 30 tablets — AB3 FDA listed —
Potassium Chloride 750 mgthis 71610-0349-98 Aphena 540 tablets — AB2 FDA listed —
Potassium Chloride Extended Release 750 mg 71610-0932-60 Aphena 90 tablets — AB2 FDA listed —
Potassium Chloride Extended-Release 750 mg 71610-0935-60 Aphena 90 tablets — AB3 FDA listed —
Potassium Chloride 750 mg 71610-0944-30 Aphena 30 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 71610-0945-30 Aphena 30 tablets — AB2 FDA listed —
Potassium chloride 750 mg 71610-0960-60 Aphena 90 tablets — — FDA listed —
Potassium Chloride 750 mg 71610-0977-30 Aphena 30 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 72189-0027-04 Direct_Rx 4 tablets — AB2 FDA listed —
Potassium chloride 750 mg 72789-0503-95 PD-Rx 1000 tablets — — FDA listed —
Potassium Chloride 750 mg 82804-0187-30 Proficient 30 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 59651-0429-01 Aurobindo 100 tablets — — FDA listed —
Potassium Chloride 750 mg 68382-0861-01 Zydus 100 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 70771-1599-00 Zydus 1000 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 63629-1072-01 Bryant 100 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 72162-1786-00 Bryant 1000 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 72865-0194-01 XLCare 100 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 82868-0027-90 Northwind 90 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 72888-0097-00 Advagen 1000 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-2866-01 Bryant 100 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-2913-01 Bryant 500 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 63629-1073-01 Bryant 1000 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 63629-1074-01 Bryant 90 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-1900-01 Bryant 30 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 71335-2607-01 Bryant 30 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 70518-3024-01 REMEDYREPACK 90 tablets — AB1 FDA listed —
potassium chloride 750 mg 71335-1781-01 Bryant 30 tablets — AB1 Discontinued —
Potassium Chloride Extended-Release 750 mg 71335-2958-01 Bryant 90 tablets — AB1 FDA listed —
Potassium Chloride Extended-Release 750 mg 63629-1075-01 Bryant 500 tablets — AB1 FDA listed —
Potassium Chloride 750 mg 82868-0111-90 Northwind 90 tablets — AB2 FDA listed —
Potassium Chloride 750 mg 67046-1032-03 Coupler 30 tablets — AB2 FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2019
On the market since
Jun 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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

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

Medicare Part D (outpatient prescription) spending for Potassium Chloride — the program that covers self-administered drugs. 42 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 Potassium Chloride. 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
$78.71M
Claims incl. refills
3.7M
Beneficiaries
2.4M
Spend / beneficiary
$33.46
Spend / claim
$21.47
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Potassium Chloride — the ingredient across all brands.

Top reported reactions

Nausea9,006
Diarrhoea8,604
Dyspnoea8,414
Fatigue8,118
Vomiting6,603
Death5,805
Pneumonia5,556

Reporter sex

120,818 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Death16,417
Life-threatening6,633
Disabling2,798
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,102 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71610-0349-15 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-15) 2022-02-08 Active
71610-0349-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-30) 2019-10-16 Active
71610-0349-45 45 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-45) 2022-02-08 Active
71610-0349-53 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-53) 2019-10-16 Active
71610-0349-60 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-60) 2019-10-16 Active
71610-0349-70 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-70) 2019-10-16 Active
71610-0349-80 180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-80) 2019-10-16 Active
71610-0349-85 200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-85) 2019-10-16 Active
71610-0349-92 270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-92) 2019-10-16 Active
71610-0349-94 360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-94) 2019-10-16 Active
71610-0349-98 You're viewing this 540 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-349-98) 2022-02-08 Active

You're viewing the largest of 11 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71610-0349-98?
NDC 71610-0349-98 is a 540-count package — 540 tablet, film coated, extended release in 1 bottle.
What is the difference between NDC 71610-0349-98 and NDC 71610-0349-15?
Both are Potassium Chloride 750 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 71610-0349-98 is the 540-count package, while NDC 71610-0349-15 is the 15 tablets package.
What NDC number is used to bill for this package of Potassium Chloride 750 mg Tablet, Film Coated, Extended Release?
Bill NDC 71610-0349-98 — the 11-digit billing format is 71610034998. 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 71610-349-98, 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: 71610-0349-98, written without dashes as 71610034998. 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 71610-0349-98, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0349) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (98) 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 Aphena Pharma Solutions - Tennessee, LLC. 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 10 other package presentations of this same product, including 15 tablets (71610-0349-15), 30 tablets (71610-0349-30), 45 tablets (71610-0349-45). 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?
Aphena Pharma Solutions - Tennessee, LLC 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.
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📄 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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 74 words ▾

1 INDICATIONS AND USAGE Potassium chloride extended-release is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release is a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Monitor serum potassium and adjust dosages accordingly. ( 2.1 ) If serum potassium is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. ( 2.1 ) Take with meals and with a glass of water or other liquid.

Swallow tablets whole without crushing, chewing or sucking. ( 2.1 ) Treatment of hypokalemia: Doses range from 40 to 100 mEq/day in divided doses. Limit doses to 40 mEq per dose.

( 2.2 ) Prevention of hypokalemia: Typical dose is 20 mEq per day. ( 2.2 )

2.1Administration and Monitoring If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust dosages accordingly. Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range.

The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms, and the clinical status of the patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate. Administration Take potassium chloride extended-release tablets with meals and with a glass of water or other liquid.

Do not take potassium chloride extended-release tablets on an empty stomach because of its potential for gastric irritation [see Warnings and Precautions (5.1) ] . Swallow tablets whole without crushing, chewing or sucking.

2.2Dosing Dosage must be adjusted to the individual needs of each patient. Dosages greater than 40 mEq per day should be divided such that no more than 40 mEq is given in a single dose. Treatment of Hypokalemia: Typical dose range is 40 to 100 mEq per day. Maintenance or Prophylaxis: Typical dose range is 20 mEq per day.

💊 Dosage Forms and Strengths 52 words ▾

3 DOSAGE FORMS AND STRENGTHS Potassium chloride extended-release tablets are supplied as: 600 mg (8 mEq) are film-coated, round light blue tablets debossed with "KC 8". 750 mg (10 mEq) are film-coated, round yellow tablets debossed with "KC 10". Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) ( 3 )

⛔ Contraindications 21 words ▾

4 CONTRAINDICATIONS Potassium chloride is contraindicated in patients on triamterene and amiloride. Concomitant use with triamterene and amiloride ( 4 )

⚠️ Warnings and Cautions 112 words ▾

5 WARNINGS AND PRECAUTIONS Gastrointestinal Irritation: Take with meals. ( 5.1 )

5.1Gastrointestinal Adverse Reactions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly if the drug maintains contact with the gastrointestinal mucosa for prolonged periods. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders. If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue potassium chloride extended-release tablets and consider possibility of ulceration, obstruction or perforation.

Potassium chloride extended-release tablets should not be taken on an empty stomach because of its potential for gastric irritation [see Dosage and Administration (2.1) ] .

🤒 Adverse Reactions 136 words ▾

6 ADVERSE REACTIONS The following adverse reactions have been identified with use of oral potassium salts. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.

There have been reports hyperkalemia and of upper and lower gastrointestinal condition including obstruction, bleeding, ulceration, perforation. Skin rash has been reported rarely. To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email [email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🔄 Drug Interactions 122 words ▾

7 DRUG INTERACTIONS Triamterene and amiloride: Concomitant use is contraindicated ( 7.1 ) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia ( 7.2 ) Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia ( 7.3 )

7.1Triamterene or amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated [see Contraindications (4) ] .

7.2Renin-angiotensin-aldosterone Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients on concomitant RAAS inhibitors.

7.3Nonsteroidal Anti-inflammatory Drugs (NSAIDs) NSAIDs may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Cirrhosis: Initiate therapy at the low end of the dosing range ( 8.6 ) Renal Impairment: Initiate therapy at the low end of the dosing range ( 8.7 )

8.1Pregnancy Risk Summary There are no human data related to use of potassium chloride extended-release during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in 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.

8.2Lactation Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

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

8.5Geriatric Use Clinical studies of potassium chloride extended-release did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6Cirrhotics Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently [see Clinical Pharmacology (12.3) ] .

8.7Renal Impairment Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions (7.2 , 7.3) ] . The serum potassium level should be monitored frequently.

Renal function should be assessed periodically.

🤰 Pregnancy 98 words ▾

8.1Pregnancy Risk Summary There are no human data related to use of potassium chloride extended-release during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in 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.

🧒 Pediatric Use 14 words ▾

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

🧓 Geriatric Use 141 words ▾

8.5Geriatric Use Clinical studies of potassium chloride extended-release did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

🆘 Overdosage 214 words ▾

10 OVERDOSAGE

10.1Symptoms The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially fatal hyperkalemia can result [see Contraindications and Warnings ] . It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 mEq/L to 8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT interval).

Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 to 12 mEq/L).

10.2Treatment Treatment measures for hyperkalemia include the following: Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties. Intravenous administration of 300 mL/hr to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. Correction of acidosis, if present, with intravenous sodium bicarbonate.

Use of exchange resins, hemodialysis or peritoneal dialysis. In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. The extended-release feature means that absorption and toxic effects may be delayed for hours.

Consider standard measures to remove any unabsorbed drug.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 mEq to 160 mEq per liter.

The normal adult plasma concentration is 3.5 mEq to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent and under steady state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.

The usual dietary intake of potassium is 50 to 100 mEq per day.

12.3Pharmacokinetics The potassium chloride in potassium chloride extended-release is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from the potassium chloride extended-release is compared to that of a true solution the extent of absorption is similar.

The extended-release properties of potassium chloride extended-release are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the Potassium chloride extended-release dose as compared to the solution. Increased urinary potassium excretion is first observed 1 hour after administration of potassium chloride extended-release, reaches a peak at approximately 4 hours, and extends up to 8 hours. Mean daily steady-state plasma levels of potassium following daily administration of potassium chloride extended-release tablets cannot be distinguished from those following administration of potassium chloride solution or from control plasma levels of potassium ion.

Specific Populations Cirrhotics Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load.

🧬 Mechanism of Action 133 words ▾

12.1Mechanism of Action The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 mEq to 160 mEq per liter.

The normal adult plasma concentration is 3.5 mEq to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent and under steady state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.

The usual dietary intake of potassium is 50 to 100 mEq per day.

📦 How Supplied / Storage and Handling 100 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium chloride extended-release tablets, USP contains 600 mg or 750 mg of potassium chloride (equivalent to 8 mEq or 10 mEq of potassium respectively). Table 1: How Supplied Dose Shape Color Debossment Bottle of 100 Tablets Bottle of 500 Tablets 600 mg (8 mEq) round light blue "KC 8" -- -- 750 mg (10 mEq) round yellow "KC 10" 42291-506-01 42291-506-50 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container with a child-resistant closure.

Keep tightly closed.

📦 Storage and Handling 34 words ▾

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container with a child-resistant closure. Keep tightly closed.

📋 Description 147 words ▾

11 DESCRIPTION Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP, are an electrolyte replenisher.

The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste.

Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide.

Yellow tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.

Blue tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake.

💬 Information for Patients 74 words ▾

17 PATIENT COUNSELING INFORMATION Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Inform patients that the wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed.

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