HomeNDC LookupIngredientsPotassium Chloride › 68462-0472-01
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(from DailyMed)

potassium chloride 1500 mg Tablet, Extended Release, 100-count

by Glenmark Pharmaceuticals Inc., USA · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-472-01)
NDC 68462-0472-01
🏷️ FDA NDC (as labeled) 68462-472-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1351 NADAC Per package$13.51 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3217/unit — full pricing hub ↓
Also comes in: 500 tablets 68462-0472-05
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 68462-472-01
Product NDC 68462-472
11-digit billing NDC 68462047201
NCPDP billing unit EA — each (per item)
RxCUI 1801294, 1801298
UNII 660YQ98I10
UPC 0368462471012, 0368462472019
Application # ANDA203562
SPL Set ID 63bedd99-0596-49d2-ad04-d1d8ac15cc42
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 ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2016-07-26
Marketing end 2026-09-01
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance POTASSIUM CHLORIDE
GPI-14 79700030100440
GCN Seq No 022346
GCN 03513
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 20 MEQ TABLET
FDB brand name Potassium Chloride
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 68462-472-01 — 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 → 68462-0472-01. 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

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA203562 (ANDA)
Labeler code68462
First marketedJul 2016
Product typeHuman Prescription Drug
Portfolio343 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 20 MEQ TABLET Ingredient Potassium Chloride
📖 What it is MedlinePlus · NLM

Potassium is essential for the proper functioning of the heart, kidneys, muscles, nerves, and digestive system. Usually the food you eat supplies all of the potassium you need. However, certain diseases (e.g., kidney disease and gastrointestinal disease with vomiting and diarrhea) and drugs, especially diuretics ('water pills'), remove potassium from the body. Potassium supplements are taken to replace potassium losses and prevent potassium deficiency. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.135 $13.51 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3217 $32.17 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.198 $0.133
▼ Down 27% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Potassium Chloride 1500 mg 00832-5325-10 Upsher-SmithLaboratories, 1000 tablets $0.135 AB1 Availability likely
Potassium Chloride 1500 mg 00904-7293-61 Major 1 tablet $0.135 Availability likely
Potassium Chloride 20 meq 00904-7548-61 Major 1 tablet $0.135 AB1 Availability likely
Potassium Chloride 1500 mg 31722-0135-01 Camber 100 tablets $0.135 AB1 Availability likely
Potassium Chloride 20 meq 60687-0756-09 American 1 tablet $0.135 AB1 Availability likely
Potassium Chloride 20 meq 62037-0720-01 Actavis 100 tablets $0.135 AB1 Availability likely
Potassium Chloride 20 meq 63304-0987-01 Sun 100 tablets $0.135 AB1 Availability likely
Potassium Chloride Extended-release 1500 mg 68001-0567-00 Bluepoint 100 tablets $0.135 AB1 Availability likely
potassium chloride 1500 mgthis 68462-0472-01 Glenmark 100 tablets $0.135 AB1 Discontinued
Potassium Chloride Extended-release 1500 mg 70010-0135-01 Granules 100 tablets $0.135 AB1 Availability likely
potassium chloride 1500 mg 72603-0338-01 Northstar 100 tablets $0.135 AB1 Availability likely
Klor-Con M 1500 mg 00245-5319-01 Upsher-Smith 1 tablet $0.148 AB1 Availability likely +10%
Potassium Chloride 1500 mg 70436-0153-01 Slate 100 tablets $0.169 AB3 Availability likely +25%
Potassium Chloride Extended-Release 1500 mg 24979-0232-01 Upsher-Smith 100 tablets $0.169 AB3 Availability likely +25%
Potassium chloride 1500 mg 72888-0076-01 Advagen 100 tablets $0.169 Availability likely +25%
Potassium Chloride Extended-Release 1500 mg 00615-8400-05 NCS 15 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 17856-1135-01 Atlantic 1 tablet AB1 FDA listed
Potassium Chloride 1500 mg 42291-0507-01 AvKARE 100 tablets AB1 FDA listed
Potassium Chloride 20 meq 43386-0917-01 Lupin 100 tablets AB1 FDA listed
Potassium Chloride 1500 mg 43547-0550-10 Solco 100 tablets AB1 FDA listed
potassium chloride 1500 mg 50090-3700-00 A-S 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 50090-5665-00 A-S 30 tablets FDA listed
Potassium Chloride 1500 mg 50090-6253-00 A-S 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 50090-6866-00 A-S 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 50090-6867-00 A-S 90 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 50090-7192-00 A-S 30 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 50090-7193-00 A-S 90 tablets AB1 FDA listed
potassium chloride 1500 mg 50090-7456-00 A-S 90 tablets AB1 FDA listed
Potassium Chloride 1500 mg 50090-7616-00 A-S 90 tablets AB1 FDA listed
Potassium Chloride 1500 mg 51655-0568-25 Northwind 60 tablets AB1 FDA listed
Klor-Con M 1500 mg 55154-5634-00 Cardinal 1 tablet AB1 FDA listed
Potassium Chloride 1500 mg 59651-0431-01 Aurobindo 100 tablets FDA listed
Potassium Chloride Extended-release 1500 mg 62207-0727-08 Granules 800 tablets AB1 FDA listed
potassium chloride 1500 mg 67296-2131-02 Redpharm 20 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 67296-2160-01 Redpharm 10 tablets AB1 FDA listed
Potassium Chloride 1500 mg 67296-2243-06 Redpharm 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 68382-0740-01 Zydus 100 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 68788-8196-03 Preferred 30 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 70518-4383-00 REMEDYREPACK 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 70771-1600-00 Zydus 1000 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 71205-0824-03 Proficient 3 tablets AB1 FDA listed
potassium chloride 1500 mg 71335-1109-01 Bryant 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 71335-1747-01 Bryant 30 tablets AB1 FDA listed
Potassium Chloride Extended-release 1500 mg 71335-1896-01 Bryant 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 71335-2045-01 Bryant 30 tablets AB1 FDA listed
Potassium Chloride 1500 mg 71610-0343-15 Aphena 15 tablets AB1 FDA listed
Potassium Chloride 1500 mg 71610-0632-15 Aphena 15 tablets AB1 FDA listed
Potassium Chloride ER 1500 mg 72189-0462-30 Direct_Rx 30 tablets AB1 FDA listed
Potassium Chloride ER 1500 mg 72189-0629-30 Direct_Rx 30 tablets AB1 FDA listed
Potassium Chloride 20 meq 72789-0365-01 PD-Rx 100 tablets AB1 FDA listed
Potassium Chloride 1500 mg 72865-0196-01 XLCare 100 tablets AB1 FDA listed
Potassium Chloride 1500 mg 72888-0099-00 Advagen 1000 tablets AB1 FDA listed
Potassium Chloride 20 meq 82804-0075-03 Proficient 3 tablets AB1 FDA listed
Potassium chloride 1500 mg 72789-0504-82 PD-Rx 500 tablets FDA listed
Potassium Chloride Extended-Release 1500 mg 82804-0057-30 Proficient 30 tablets AB3 FDA listed
Potassium Chloride 1500 mg 00615-8580-05 NCS 15 tablets AB3 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

🏛️
2016
On the market since
Jul 2016
📍
2026
Currently FDA-listed
10 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68462-0472-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.6K
Units reimbursed last 4 qtrs
112.8K
Gross reimbursed last 4 qtrs
$36.3K
Avg / prescription
$13.85
Avg / unit
$0.3217
Latest quarter Q4 2025
122Rx
Medicaid pays / ea
$0.3217
gross reimbursed
vs
NADAC / ea
$0.1351
acquisition cost
=
Spread
+$0.1866
+138% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
35% FFS 65% MCO
Fee-for-service · 909 Rx Managed care · 1,712 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 1,104 units · 141 per 100k residents ND Minnesota: 998 units · 17.4 per 100k residents MN Wisconsin: 4,717 units · 79.8 per 100k residents WI Michigan: 4,352 units · 43.4 per 100k residents MI New York: 10,506 units · 53.7 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 759 units · 23.7 per 100k residents IA Illinois: 5,587 units · 44.5 per 100k residents IL Indiana: no data reported IN Ohio: 6,053 units · 51.4 per 100k residents OH Pennsylvania: 10,714 units · 82.7 per 100k residents PA New Jersey: 2,978 units · 32.1 per 100k residents NJ Massachusetts: no data reported MA California: 7,807 units · 20.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 396 units · 20.0 per 100k residents NE Missouri: 1,837 units · 29.6 per 100k residents MO Kentucky: 2,295 units · 50.7 per 100k residents KY West Virginia: 7,914 units · 447 per 100k residents WV Virginia: 5,470 units · 62.8 per 100k residents VA Maryland: 497 units · 8.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 436 units · 14.8 per 100k residents KS Arkansas: 475 units · 15.5 per 100k residents AR Tennessee: no data reported TN North Carolina: 10,190 units · 94.0 per 100k residents NC South Carolina: 4,282 units · 79.7 per 100k residents SC Delaware: no data reported DE Oklahoma: 624 units · 15.4 per 100k residents OK Louisiana: 13,311 units · 291 per 100k residents LA Mississippi: no data reported MS Alabama: 822 units · 16.1 per 100k residents AL Georgia: 1,094 units · 9.9 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,177 units · 3.9 per 100k residents TX Florida: 863 units · 3.8 per 100k residents FL
Units reimbursed · per 100k residents
3.8447
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 447 /100k
2 Louisiana 291 /100k
3 North Dakota 141 /100k
4 North Carolina 94.0 /100k
5 Pennsylvania 82.7 /100k
6 Wisconsin 79.8 /100k
7 South Carolina 79.7 /100k
8 Virginia 62.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
500 tablets68462-0472-05 7,949 Rx · $109,759
Drug total (last 4 qtrs): 10,570 Rx · 450,413 units · $146,065 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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 Per unit Per pack Marketing startStatus
68462-0472-01 You're viewing this 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-472-01) $0.1351 / ea $13.51 2016-07-26 Discontinued by firm
68462-0472-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-472-05) $0.1351 / ea $67.53 2016-07-26 Discontinued by firm

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1351 NADAC).

This pack accounts for about 25% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 68462-0472-01?
NDC 68462-0472-01 is a 100-count package — 100 tablet, extended release in 1 bottle.
What is the difference between NDC 68462-0472-01 and NDC 68462-0472-05?
Both are potassium chloride 1500 mg Tablet, Extended Release — the drug itself is identical. NDC 68462-0472-01 is the 100-count package, while NDC 68462-0472-05 is the 500 tablets package.
What NDC number is used to bill for this package of potassium chloride 1500 mg Tablet, Extended Release?
Bill NDC 68462-0472-01 — the 11-digit billing format is 68462047201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ 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) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68462-472-01, 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: 68462-0472-01, written without dashes as 68462047201. 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 68462-0472-01, the first segment (68462) is the labeler code FDA assigned to Glenmark Pharmaceuticals Inc., USA; the middle segment (0472) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 500 tablets (68462-0472-05). 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?
Glenmark Pharmaceuticals Inc., USA 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 211 words

INDICATIONS AND USAGE BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS. 1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis.

If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia. 2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION The usual dietary intake of potassium by the average adult is 50 mEq to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 mEq or more of potassium from the total body store. Dosage must be adjusted to the individual needs of each patient.

The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 mEq to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

Each potassium chloride extended-release tablet, USP 20 mEq provides 20 mEq of potassium. Each potassium chloride extended-release tablet, USP 10 mEq provides 10 mEq of potassium. Potassium chloride tablets, USP should be taken with meals and with a glass of water or other liquid.

This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS ). Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration: 1. Break the tablet in half, and take each half separately with a glass of water.

2. Prepare an aqueous (water) suspension as follows: 1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).

2. Allow approximately 2 minutes for the tablet(s) to disintegrate. 3.

Stir for about half a minute after the tablet(s) has disintegrated. 4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.

5. Add another 1 fluid ounce of water, swirl, and consume immediately. 6.

Then, add an additional 1 fluid ounce of water, swirl, and consume immediately. Aqueous suspension of potassium chloride that is not taken immediately should be discarded. The use of other liquids for suspending potassium chloride tablets, USP is not recommended.

Contraindications 173 words

CONTRAINDICATIONS Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis, such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (e.g., spironolactone, triamterene, amiloride) (see OVERDOSAGE) .

Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of potassium chloride (see PRECAUTIONS: Information for Patients, and DOSAGE AND ADMINISTRATION sections). All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

⚠️ Warnings ~2 min read

WARNINGS Hyperkalemia (see OVERDOSAGE ) In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic.

The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment. Interaction with Potassium-Sparing Diuretics Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Renin- Angiotensin Aldosterone System 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 receiving concomitant RAAS therapy. Interaction with Nonsteroidal Anti-Inflammatory Drugs : Nonsteroidal anti-inflammatory drugs (NSAIDs) may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system.

Closely monitor potassium in patients receiving concomitant NSAID therapy. Gastrointestinal Lesions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of potassium chloride are associated with an increased frequency of small bowel lesions (40 to 50 per 100,000 patient years) compared to sustained release wax matrix formulations (less than one per 100,000 patient years).

Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. Potassium chloride is a tablet formulated to provide a controlled rate of release of microencapsulated potassium chloride and thus to minimize the possibility of a high local concentration of potassium near the gastrointestinal wall. Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral potassium chloride therapy.

The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (i.e., 96 mEq per day in divided doses of potassium chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying).

The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing). The relevance of these findings to the usual conditions (i.e., non-fasting, no anticholinergic agent, smaller doses) under which controlled-release potassium chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to micro-encapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations.

Potassium chloride extended-release tablets should be discontinued immediately and the possibility of ulceration, obstr…

🤒 Adverse Reactions 90 words

ADVERSE REACTIONS One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS , and OVERDOSAGE ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ). The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.

These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.

🔄 Drug Interactions 14 words

Drug Interactions Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see Error! Hyperlink reference not valid. ).

🤰 Pregnancy 36 words

Pregnancy Animal reproduction studies have not been conducted with potassium chloride. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

🧒 Pediatric Use 12 words

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

🧓 Geriatric Use 139 words

Geriatric Use Clinical studies of potassium chloride 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 ~1 min read

OVERDOSAGE The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously, 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 to 8 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval).

Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 mEq to 12 mEq/L). Treatment measures for hyperkalemia include the following: Patients should be closely monitored for arrythmias and electrolyte changes. 1.

Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others. 2. Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.

3. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 units to 20 units of crystalline insulin per 1,000 mL. 4.

Correction of acidosis, if present, with intravenous sodium bicarbonate. 5. 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

CLINICAL PHARMACOLOGY 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 to 160 mEq per liter.

The normal adult plasma concentration is 3.5 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. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition.

Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances or cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long-term diuretic therapy, supplemental potassium in the form of high-potassium food or potassium chloride may be able to restore normal potassium levels. In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

📦 How Supplied / Storage and Handling 119 words

HOW SUPPLIED Potassium chloride extended-release tablets, USP 20 mEq are available in bottles of 100 (NDC 68462-472-01) and 500 (NDC 68462-472-05). Potassium chloride extended-release tablets, USP 20 mEq are white to off-white, capsule-shaped biconvex tablets debossed with ‘472’ on one side and scored on the other side. Potassium chloride extended-release tablets, USP 10 mEq are available in bottles of 100 (NDC 68462-471-01) and 500 (NDC 68462-471-05).

Potassium chloride extended-release tablets, USP 10 mEq are white to off-white, capsule-shaped biconvex tablets debossed with ‘471’ on one side and plain on the other side. Storage Conditions Keep tightly closed. 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].

📦 Storage and Handling 27 words

Storage Conditions Keep tightly closed. 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].

📋 Description ~1 min read

DESCRIPTION The potassium chloride extended-release tablets, USP 20 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The potassium chloride extended-release tablets, USP 10 mEq product is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet.

These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl.

Potassium chloride, USP occurs as a white, crystalline powder. It is odorless and has a saline taste. It is freely soluble in water and practically insoluble in ethanol.

Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrate within 1 minute. The microencapsulated crystals are formulated to provide an extended-release of potassium chloride.

This product complies with USP assay preparation 2. Inactive Ingredients: crospovidone, ethylcellulose, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and talc.

💬 Information for Patients ~1 min read

Information for Patients Physicians should consider reminding the patient of the following: To take each dose with meals and with a full glass of water or other liquid. To take each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration: 1.

Break the tablet in half, and take each half separately with a glass of water. 2. Prepare an aqueous (water) suspension as follows: 1.

Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces). 2. Allow approximately 2 minutes for the tablet(s) to disintegrate.

3. Stir for about half a minute after the tablet(s) has disintegrated. 4.

Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw. 5. Add another 1 fluid ounce of water, swirl, and consume immediately.

6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately. Aqueous suspension of potassium chloride that is not taken immediately should be discarded.

The use of other liquids for suspending potassium chloride tablets is not recommended. To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.

To check with the physician at once 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 ↗
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.