Home › NDC Lookup › Ingredients › Potassium Chloride › 71335-1050-07

Potassium Chloride 750 mg Tablet, Film Coated, Extended Release, 10-count

by Bryant Ranch Prepack · 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1050-7)

NDC 71335-1050-07

🏷️ FDA NDC (as labeled) 71335-1050-7 billing pads the package segment with a zero

This package

Contains10-count Pack sizes7 compare ↓

Also comes in: 15 tablets 71335-1050-04 28 tablets 71335-1050-06 30 tablets 71335-1050-01 60 tablets 71335-1050-02 90 tablets 71335-1050-03 180 tablets 71335-1050-05

Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm

🗂️ Data synced Jul 22, 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 Dr. Brian Staiger, PharmD

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 · 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 Nov 2021. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-1050-7

Product NDC 71335-1050

11-digit billing NDC 71335105007

Application # NDA018279

SPL Set ID 418fa94a-9e92-4f06-b8c2-020c885e3412

Established class (EPC) Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt

DEA schedule Non-controlled

Marketing category NDA AUTHORIZED GENERIC

Marketing status Discontinued

FDA listing status Discontinued by firm (certified through Nov 2021)

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance POTASSIUM CHLORIDE

Why two NDCs? The FDA registers this code as 71335-1050-7 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71335-1050-07. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack

Application holderABBVIE INC

FDA applicationNDA018279 (NDA AUTHORIZED GENERIC)

Labeler code71335

Product typeHuman Prescription Drug

Portfolio4,434 products on file

🔎 All NDCs from Bryant Ranch Prepack

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

📖 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Potassium Chloride (prescription drug) — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Potassium Chloride (prescription drug) (17 interactions) — ranked by severity →

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

ShapeOval

ImprintKTAB;10

Size15 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 H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
UNII D5340Y2I9G
Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
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 7Z8S9VYZ4B
Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
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 I9O0E3H2ZE
Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
UNII 32K497ZK2U
Polyvinyl acetate is a synthetic plastic polymer derived from vinyl acetate. It acts as a binder and film-forming agent in medicines, helping to hold ingredients together and create protective coatings on tablets or capsules.
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 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.
UNII CHI530446X
Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.

10 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 system	Per each	Per 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 · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 15 tablets 28 tablets 30 tablets 60 tablets 90 tablets 180 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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 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 mg 71610-0349-15	Aphena	15 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 mgthis 71335-1050-07	Bryant	10 tablets	—	—	Discontinued	—

About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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

📍

2026

Currently FDA-listed

listed with the FDA

🔓

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

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

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 NDC	Description	Marketing start	Status
71335-1050-01	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1050-1)	2013-12-12	Discontinued by firm
71335-1050-02	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1050-2)	2013-12-12	Discontinued by firm
71335-1050-03	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1050-3)	2013-12-12	Discontinued by firm
71335-1050-04	15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1050-4)	2013-12-12	Discontinued by firm
71335-1050-05	180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1050-5)	2013-12-12	Discontinued by firm
71335-1050-06	28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1050-6)	2013-12-12	Discontinued by firm
71335-1050-07 You're viewing this	10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1050-7)	2019-01-11	Discontinued by firm

You're viewing the smallest of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-1050-07?

NDC 71335-1050-07 is a 10-count package — 10 tablet, film coated, extended release in 1 bottle.

What is the difference between NDC 71335-1050-07 and NDC 71335-1050-04?

Both are Potassium Chloride 750 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 71335-1050-07 is the 10-count package, while NDC 71335-1050-04 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 71335-1050-07 — the 11-digit billing format is 71335105007. 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 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	✓ 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	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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.

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 71335-1050-7, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-1050-07, written without dashes as 71335105007. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 71335-1050-07, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1050) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 6 other package presentations of this same product, including 15 tablets (71335-1050-04), 28 tablets (71335-1050-06), 30 tablets (71335-1050-01). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 74 words ▾

1 INDICATIONS AND USAGE Potassium chloride extended-release tablets are 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 tablets are 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 ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Monitor serum potassium and adjust dosages accordingly (2.1) If serum potassium concentration 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. (2.1) Treatment of hypokalemia: Typical dose range is 40-100 mEq per day in divided doses.

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

2.1Monitoring and Administration If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust the dose based on serum potassium level. 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 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 20 mEq per day should be divided such that no more than 20 mEq is given in a single dose. Treatment of hypokalemia: Typical dose range is 40-100 mEq per day. Prevention of hypokalemia: Typical dose is 20 mEq per day.

Do not take 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.

💊 Dosage Forms and Strengths 96 words ▾

3 DOSAGE FORMS AND STRENGTHS 8 mEq (600 mg): Round, yellow, debossed extended-release tablets with “K-TAB” on one side 10 mEq (750 mg): Ovaloid, yellow, debossed extended-release tablets with “10” on one side and “K‑TAB” on the other side 10 mEq (750 mg): Ovaloid, yellow, debossed extended-release tablets with the “a” logo on one side and “K‑TAB” on the other side 20 mEq (1500 mg): Ovaloid, white, debossed extended-release tablets with “K-TAB” on one side 8 mEq (600 mg) oral tablets (3) 10 mEq (750 mg) oral tablets (3) 20 mEq (1500 mg) oral tablets (3)

⛔ Contraindications 21 words ▾

4 CONTRAINDICATIONS Potassium chloride is contraindicated in patients on triamterene or amiloride. Concomitant use with triamterene and amiloride (4 , 7.1)

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Gastrointestinal Adverse Reactions: Can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when in prolonged contact with the gastrointestinal mucosa. 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 when the drug remains in contact with the gastrointestinal mucosa for a prolonged period of time. 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 151 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 of hyperkalemia and of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, perforation [see Warnings and Precautions ( 5.1 ) and Overdosage ( 10 )] . Skin rash has been reported rarely. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea (6) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7.1Triamterene and Amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications ( 4 )] .

🔄 Drug Interactions 187 words ▾

7 DRUG INTERACTIONS Renin-angiotensin-aldosterone system inhibitors: Monitor for hyperkalemia (7.2) Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia (7.3)

7.1Triamterene and Amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications ( 4 )] .

7.2Renin-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.

7.3Nonsteroidal 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.

👥 Use in Specific Populations ~3 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 tablets 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 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as potassium chloride extended-release tablets becomes part of the body potassium pool, as 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 of potassium chloride extended-release tablets in children have not been established.

8.5Geriatric Use Clinical studies of potassium chloride extended-release tablets 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 Doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. 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.

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.

8.2…

🆘 Overdosage ~2 min read ▾

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 ( 4 ) and Warnings and Precautions ( 5.1 )] . Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss P-waves, depression of S-T segments, and prolongation of the QT intervals).

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

10.2Treatment Treatment measures for hyperkalemia include the following: Monitor closely for arrhythmias and electrolyte changes. Eliminate 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. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.

Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. Correct acidosis, if present, with intravenous sodium bicarbonate. Use exchange resins, hemodialysis, or peritoneal dialysis.

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.

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

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The potassium ion (K + ) 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 impulse; 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.

12.2Pharmacokinetics 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 [see Use in Specific Populations ( 8.6 )] .

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

📦 How Supplied / Storage and Handling 97 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 71335-1050 NDC: 71335-1050-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-1050-2 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-1050-3 90 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-1050-4 15 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-1050-5 180 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-1050-6 28 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE NDC: 71335-1050-7 10 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE Product: 71335-1210 NDC: 71335-1210-1 180 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

📋 Description 150 words ▾

11 DESCRIPTION Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride containing 600 mg, 750 mg and 1500 mg of potassium chloride, USP, equivalent to 8 mEq, 10mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as 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.

The 8 mEq and 10 mEq tablets also contain castor oil, cellulosic polymers, colloidal silicon dioxide, D&C Yellow No. 10, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin, and vitamin E. The 20 mEq tablets also contain castor oil, cellulosic polymers, colloidal silicon dioxide, magnesium stearate, paraffin, polyvinyl acetate, titanium dioxide, vanillin, and vitamin E.

💬 Information for Patients 98 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. Advise patients to seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed. Inform patients that the wax tablet is not absorbed and may be excreted intact in the stool.

If the patient observes this, it is not an indication of lack of effect. Manufactured by: AbbVie LTD Barceloneta, PR 00617 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 03-B637 May, 2018

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysphagia: Trouble or discomfort swallowing food, liquids, or pills.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

enteric-coated: A special coating that keeps a pill from dissolving in the stomach, so it opens up further along in the intestine.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

gastrointestinal bleeding: Bleeding anywhere along the digestive tract, from the food pipe down to the bowel.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 71335-1048-01 · Bryant 71335-1051-01 · Bryant →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Potassium Chloride 750 mg Tablet, Film Coated, Extended Release, 10-count

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

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

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 Full prescribing information FDA SPL

10 OVERDOSAGE

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups