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IBUPROFEN IBUOROFEN 800 mg Tablet, Film Coated, 60-count

by Direct_Rx · 60 TABLET, FILM COATED in 1 BOTTLE (61919-463-60)

NDC 61919-0463-60

🏷️ FDA NDC (as labeled) 61919-463-60 billing pads the product segment with a zero

This package

Contains60-count Pack sizes9 compare ↓

Also comes in: 15 tablets 61919-0463-15 21 tablets 61919-0463-21 30 tablets 61919-0463-30 40 tablets 61919-0463-40 45 tablets 61919-0463-45 90 tablets 61919-0463-90 100 tablets 61919-0463-71 120 tablets 61919-0463-72

Rx only Generic On market Non-controlled

🗂️ Data synced Sep 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 61919-463-60

Product NDC 61919-463

11-digit billing NDC 61919046360

NCPDP billing unit EA — each (per item)

RxCUI 197807

UNII WK2XYI10QM

Application # ANDA091625

SPL Set ID 67377024-fe71-4fa0-e053-2991aa0afba2

Established class (EPC) Nonsteroidal Anti-inflammatory Drug

Mechanism of action Cyclooxygenase Inhibitors

Chemical class Anti-Inflammatory Agents, Non-Steroidal

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-08-22

Route ORAL

Dosage form TABLET, FILM COATED

Substance IBUPROFEN

GPI-14 66100020000340

GPI class Ibuprofen

GCN Seq No 008350

GCN 35744

HICL code 003723

Ingredient (HICL) Ibuprofen

HIC1 code S

Therapeutic class — broad (HIC1) Locomotor System

HIC2 code S2

Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints

HIC3 code S2B

Therapeutic class — specific (HIC3) Nsaids, Cyclooxygenase Inhibitor Type Analgesics

AHFS code 28:08.04.04

AHFS class Reversible Cox-1/Cox-2 Inhibitors

FDB label name IBUPROFEN 800 MG TABLET

FDB brand name Ibuprofen

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 61919-463-60 — 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 → 61919-0463-60. 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 Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug

Drug family (ATC) Other cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid derivatives

How it works Cyclooxygenase Inhibitors

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

LabelerDirect_Rx

Application holderGRANULES INDIA LTD

FDA applicationANDA091625 (ANDA)

Labeler code61919

First marketedAug 2019

Product typeHuman Prescription Drug

Portfolio352 products on file

🔎 All NDCs from Direct_Rx

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 IBUPROFEN 800 MG TABLET Ingredient Ibuprofen

📖 What it is MedlinePlus · NLM

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a clas...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It does a lot more than just kill pain. Ibuprofen is an anti-inflammatory drug, so it relieves pain, reduces swelling and inflammation, and brings down fever. Over-the-counter prod...
What's ibuprofen actually used for — is it just a painkiller?
Yes, it really does help. Ibuprofen can irritate the stomach lining, so taking it with food or a glass of milk significantly reduces the chance of nausea or stomach upset. You don'...
Should I take ibuprofen with food? Does it really matter?

📖 Read our full Ibuprofen guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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 white

ShapeOval

ImprintI;7

Size17 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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
UNII R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
UNII RDH86HJV5Z
Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
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 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price 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 21 tablets 30 tablets 40 tablets 45 tablets 90 tablets 100 tablets 120 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
Ibuprofen 800 mg 42543-0964-07	Strides	500 tablets	$0.057	AB	Discontinued	—
Ibuprofen 800 mg 00904-5855-40	Major	500 tablets	$0.057	AB	Availability likely	—
Ibuprofen 800 mg 49483-0604-01	TIME	100 tablets	$0.057	AB	Availability likely	—
Ibuprofen 800 mg 55111-0684-01	Dr.	100 tablets	$0.057	—	Availability likely	—
Ibuprofen 800 mg 59651-0362-01	Aurobindo	100 tablets	$0.057	AB	Availability likely	—
Ibuprofen 800 mg 60687-0468-01	American	100 tablets	$0.057	AB	Availability likely	—
Ibuprofen 800 mg 62135-0402-12	Chartwell	120 tablets	$0.057	—	Availability likely	—
Ibuprofen 800 mg 64380-0807-06	Strides	100 tablets	$0.057	AB	Availability likely	—
Ibuprofen 800 mg 67877-0321-01	Ascend	100 tablets	$0.057	—	Availability likely	—
Ibuprofen 800 mg 68645-0563-54	Legacy	30 tablets	$0.057	AB	Availability likely	—
Ibuprofen 800 mg 69367-0396-01	Westminster	100 tablets	$0.057	—	Availability likely	—
Ibuprofen 800 mg 70512-0780-10	SOLA	100 tablets	$0.057	AB	Availability likely	—
Ibuprofen 800 mg 76282-0714-10	EXELAN	100 tablets	$0.057	AB	Availability likely	—
Ibuprofen 800 mg 71921-0182-01	Florida	100 tablets	$0.066	AB	FDA listed	—
Ibuprofen 800 mg 69238-1103-05	Amneal	500 tablets	$0.074	AB	FDA listed	—
Ibuprofen 800 mg 00615-8311-39	NCS	30 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 00904-7592-40	Major	500 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 11788-0010-00	AiPing	17000 tablets	—	—	Discontinued	—
Ibuprofen 800 mg 25000-0123-03	MARKSANS	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 43063-0914-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-2548-00	A-S	10 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 50090-2549-00	A-S	4 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-2597-00	A-S	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-5444-04	A-S	28 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-5445-00	A-S	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-5446-00	A-S	10 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-6616-00	A-S	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-6645-00	A-S	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-6886-00	A-S	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-7281-05	A-S	90 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 50090-7282-00	A-S	90 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 50090-7283-00	A-S	10 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 50090-7320-00	A-S	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 50090-7905-00	A-S	500 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 51407-0841-01	Golden	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 51655-0275-20	Northwind	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 51655-0385-20	Northwind	20 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 53746-0137-01	Amneal	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 53746-0466-01	Amneal	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 54348-0825-00	PharmPak,	1 tablet	—	AB	FDA listed	—
Ibuprofen 800 mg 55154-1342-00	Cardinal	1 tablet	—	AB	FDA listed	—
Ibuprofen 800 mg 60760-0596-20	St.	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 60760-0604-00	St.	100 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 60760-0844-20	ST.	20 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 60760-0929-20	St.	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mgthis 61919-0463-60	Direct_Rx	60 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 62207-0356-42	Granules	50 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 63187-0022-15	Proficient	15 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 63187-0962-20	Proficient	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 63187-0992-15	Proficient	15 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 63629-1470-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 65162-0466-03	Amneal	30 tablets	—	AB	FDA listed	—
Ibu 800 mg 66267-0963-00	NuCare	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 67046-1214-03	Coupler	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 67046-1606-03	Coupler	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 67296-2196-01	Redpharm	10 tablets	—	—	FDA listed	—
Ibu 800 mg 68071-3053-00	NuCare	12 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-3362-00	NuCare	12 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 68071-3415-06	NuCare	6 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-3552-03	NuCare	3 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-3696-08	NuCare	180 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-3793-01	NuCare	21 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 68071-3966-06	NuCare	6 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 68071-4845-01	NuCare	21 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-4949-03	NuCare	3 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-5135-00	NuCare	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-5140-03	NuCare	3 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68788-8319-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68788-8710-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68788-8757-01	Preferred	100 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 68788-9112-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 69367-0449-01	Westminster	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70010-0068-89	Granules	11400 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-0176-02	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-1409-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-3178-00	REMEDYREPACK	15 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-4010-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-4259-00	REMEDYREPACK	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 71335-1073-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71335-1206-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71335-1396-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71335-2689-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71335-3108-01	Bryant	500 tablets	—	AB	FDA listed	—
Ibu 800 mg 71610-0550-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0890-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0892-53	Aphena	60 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0897-53	Aphena	60 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0898-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0901-60	Aphena	90 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 71610-0967-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72189-0266-15	DIRECT	15 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72189-0556-20	Direct_Rx	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72603-0910-01	NorthStar	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0186-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0200-10	PD-Rx	10 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0218-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0364-10	PD-Rx	10 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0382-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0565-15	PD-Rx	15 tablets	—	—	FDA listed	—
ibuprofen 800 mg 73086-0212-01	SKYA	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 73614-0201-03	Brisk	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 75907-0329-89	Dr.	1500 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 76420-0415-01	Asclemed	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 76420-0577-01	Asclemed	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 76420-0848-01	Asclemed	100 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 80425-0046-01	Advanced	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0047-01	Advanced	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0089-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0243-04	Advanced	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0393-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0537-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 82804-0227-15	Proficient	15 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 82804-0293-24	Proficient	24 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 82868-0069-30	Northwind	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 83008-0050-30	Quality	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 85509-1466-03	PHOENIX	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 85509-2396-03	PHOENIX	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 87441-0045-01	Unit	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2019

On the market since

Aug 2019

📍

2026

Currently FDA-listed

7 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

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

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

Medicare Part D (outpatient prescription) spending for Ibuprofen — the program that covers self-administered drugs. 19 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 Ibuprofen. 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

$12.28M

Claims incl. refills

1.8M

Beneficiaries

1.4M

Spend / beneficiary

$8.95

Spend / claim

$6.72

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 Ibuprofen (this brand).

Top reported reactions

Pain15,070

Fatigue14,487

Nausea13,523

Headache12,103

Arthralgia10,926

Dyspnoea10,541

Vomiting9,986

Age at onset

Neonate574

Infant287

Child1,271

Adolescent1,343

Adult21,489

Elderly7,059

Reporter sex

Serious outcomes

Hospitalization70,668

Death16,232

Life-threatening13,224

Disabling9,167

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
61919-0463-30	30 TABLET, FILM COATED in 1 BOTTLE (61919-463-30)	2018-03-12	Inactivated by FDA
61919-0463-21	21 TABLET, FILM COATED in 1 BOTTLE (61919-463-21)	2019-08-22	Active
61919-0463-40	40 TABLET, FILM COATED in 1 BOTTLE (61919-463-40)	2019-08-22	Active
61919-0463-45	45 TABLET, FILM COATED in 1 BOTTLE (61919-463-45)	2019-08-22	Active
61919-0463-60 You're viewing this	60 TABLET, FILM COATED in 1 BOTTLE (61919-463-60)	2019-08-22	Active
61919-0463-71	100 TABLET, FILM COATED in 1 BOTTLE (61919-463-71)	2019-08-22	Active
61919-0463-90	90 TABLET, FILM COATED in 1 BOTTLE (61919-463-90)	2019-08-22	Active
61919-0463-72	120 TABLET, FILM COATED in 1 BOTTLE (61919-463-72)	2019-08-22	Active
61919-0463-15	15 TABLET, FILM COATED in 1 BOTTLE (61919-463-15)	2019-08-22	Active

You're viewing one of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61919-0463-60?

NDC 61919-0463-60 is a 60-count package — 60 tablet, film coated in 1 bottle.

What is the difference between NDC 61919-0463-60 and NDC 61919-0463-15?

Both are IBUPROFEN IBUOROFEN 800 mg Tablet, Film Coated — the drug itself is identical. NDC 61919-0463-60 is the 60-count package, while NDC 61919-0463-15 is the 15 tablets package.

What NDC number is used to bill for this package of IBUPROFEN IBUOROFEN 800 mg Tablet, Film Coated?

Bill NDC 61919-0463-60 — the 11-digit billing format is 61919046360. 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

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What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
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Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

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

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 61919-463-60, 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: 61919-0463-60, written without dashes as 61919046360. 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 61919-0463-60, the first segment (61919) is the labeler code FDA assigned to Direct_Rx; the middle segment (0463) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Direct_Rx. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 8 other package presentations of this same product, including 15 tablets (61919-0463-15), 21 tablets (61919-0463-21), 30 tablets (61919-0463-30). 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?

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

Do I need a prescription for this product?

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

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

Where does this data come from?

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

📄 Full prescribing information FDA SPL

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

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide

🚨 Boxed Warning 116 words ▾

BOXED WARNING Cardiovascular Thrombotic Events · Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS). · Ibuprofen Tablets is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

🎯 Indications and Usage 92 words ▾

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

⏱️ Dosage and Administration ~2 min read ▾

Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient's needs.

Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk. Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease: Suggested Dosage: 1200 mg to 3200 mg daily (300 mg four times a day; 400 mg, 600 mg or 800 mg three times a day or four times a day).

Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis. The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (see CLINICAL PHARMACOLOGY for effects of food on rate of absorption).

The availability of three tablet strengths facilitates dosage adjustment. In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain. In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose. Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.

⛔ Contraindications 69 words ▾

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticarial, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions andPRECAUTIONS, Preexisting Asthma).

Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

⚠️ Warnings ~3 min read ▾

Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as [active moiety], increases the risk of serious gastrointestinal (GI) events (see WARNINGS). Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

NSAIDs are contraindicated in the setting of CABG (seeCONTRAINDICATIONS). Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.

Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of Ibuprofen Tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Ibuprofen Tablets is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Hypertension NSAIDs including ibuprofen tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen tablets, should be used with caution in patients with hypertension.

Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.

Additionally, fluid retention an…

🤒 Adverse Reactions ~2 min read ▾

The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%. In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin or indomethacin-treated patients.

Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.

Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with ibuprofen tablets has not been established. Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis.

The increases in incidence were slight and still within the ranges reported in the table. Incidence Greater than 1%(but less than 3%) Probable Causal Relationship Precise Incidence Unknown (but less than 1%) Probable Causal Relationship** Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown** GASTROINTESTINAL Nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloating and flatulence) Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis CENTRAL NERVOUS SYSTEM Dizziness*, headache, nervousness Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS) Paresthesias, hallucinations, dream abnormalities, pseudo-tumor cerebri DERMATOLOGIC Rash*, (including maculopapular type), pruritus Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia Toxic epidermal necrolysis, photoallergic skin reactions SPECIAL SENSES Tinnitus Hearing loss, amblyopia (blurred and/or diminished vision, scotomata and /or changes in color vision) (see PRECAUTIONS) Conjunctivitis, diplopia, optic neuritis, cataracts HEMATOLOGIC Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit (see PRECAUTIONS) Bleeding episodes (e.g., epistaxis, menorrhagia) METABOLIC/ENDOCRINE Decreased appetite Gynecomastia, hypoglycemic reaction, acidosis CARDIOVASCULAR Edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS) Congestive heart failure in patients with marginal cardiac function, elevate blood pressure, palpitations Arrhythmias (sinus tachycardia, sinus bradycardia) ALLERGIC Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS) Serum sickness, lupus erythematosus syndrome.

Henoch-Schonlein vasculitis, angioedema RENAL Acute renal failure (see PRECAUTIONS), decreased creatinine clearance, poliuria, azotemia, cystitis, hematuria Renal papillary necrosis MISCELLANEOUS Dry eyes and mouth, gingival ulcer, rhinitis *Reactions occurring in 3% to 9% of patients treated with ibuprofen. (Those reactions occurring in less than 3% of the patients are unmarked). **Reactions are classified under “Probable Causal Relationship (PCR)” if there has been one positive rechallenge or if thr…

🆘 Overdosage ~1 min read ▾

Approximately 1½ hours after the reported ingestion of from 7 to10 ibuprofen tablets (400 mg), a 19-month old child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic, responding only to painful stimuli. This type of stimulus, however, was sufficient to induce respiration. Oxygen and parenteral fluids were given; a greenish-yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen.

Two hours after ingestion the child's condition seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting from 5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By four hours post-ingestion she could be aroused easily, sit by herself and respond to spoken commands.

Blood level of ibuprofen was 102.9 mcg/mL approximately 8½ hours after accidental ingestion. At 12 hours she appeared to be completely recovered. In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequelae.

Blood level in one child 90 minutes after ingestion was 700 mcg/mL about 10 times the peak levels seen in absorption-excretion studies. A 19-year old male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness, and nystagmus was noted. After hospitalization, parenteral hydration and three days bed rest, he recovered with no reported sequelae.

In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen tablets.

🧬 Clinical Pharmacology ~3 min read ▾

Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. In clinical studies in patients with rheumatoid arthritis and osteoarthritis, ibuprofen tablets have been shown to be comparable to aspirin in controlling pain and inflammation and to be associated with a statistically significant reduction in the milder gastrointestinal side effects (see ADVERSE REACTIONS).

Ibuprofen tablets may be well tolerated in some patients who have had gastrointestinal side effects with aspirin, but these patients when treated with ibuprofen tablets should be carefully followed for signs and symptoms of gastrointestinal ulceration and bleeding. Although it is not definitely known whether ibuprofen tablets causes less peptic ulceration than aspirin, in one study involving 885 patients with rheumatoid arthritis treated for up to one year, there were no reports of gastric ulceration with ibuprofen tablets whereas frank ulceration was reported in 13 patients in the aspirin group (statistically significant p<0.001).

Gastroscopic studies at varying doses show an increased tendency toward gastric irritation at higher doses. However, at comparable doses, gastric irritation is approximately half that seen with aspirin. Studies using 51Cr-tagged red cells indicate that fecal blood loss associated with ibuprofen tablets in doses up to 2400 mg daily did not exceed the normal range, and was significantly less than that seen in aspirin-treated patients.

In clinical studies in patients with rheumatoid arthritis, ibuprofen tablets have been shown to be comparable to indomethacin in controlling the signs and symptoms of disease activity and to be associated with a statistically significant reduction of the milder gastrointestinal (see ADVERSE REACTIONS) and CNS side effects. Ibuprofen tablets may be used in combination with gold salts and/or corticosteroids. Controlled studies have demonstrated that ibuprofen tablets are more effective analgesic than propoxyphene for the relief of episiotomy pain, pain following dental extraction procedures, and for the relief of the symptoms of primary dysmenorrhea.

In patients with primary dysmenorrhea, ibuprofen tablets have been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce resting and active intrauterine pressure, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia. The ibuprofen in ibuprofen tablets is rapidly absorbed.

Peak serum ibuprofen levels are generally attained one to two hours after administration. With single doses up to 800 mg, a linear relationship exists between amount of drug administered and the integrated area under the serum drug concentration vs time curve. Above 800 mg, however, the area under the curve increases less than proportional to increases in dose.

There is no evidence of drug accumulation or enzyme induction. The administration of ibuprofen tablets either under fasting conditions or immediately before meals yields quite similar serum ibuprofen concentration-time profiles. When ibuprofen tablets are administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the extent of absorption.

The bioavailability of the drug is minimally altered by the presence of food. A bioavailability study has shown that there was no interference with the absorption of ibuprofen when ibuprofen tablets were given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide. Ibuprofen is rapidly metabolized and eliminated in the urine.

The excretion of ibuprofen is virtually complete 24 hours after the last dose. The serum half-life is 1.8 to 2.0 hours. Studies have shown that following ingestion of the drug, 45% t…

📦 How Supplied / Storage and Handling 37 words ▾

800 mg (white to off-white, caplet, 'I 10' debossing on one side and plain on the other side) Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature]. Avoid excessive heat above 40ºC (104ºF).

📋 Description 98 words ▾

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: [ibuprofen-structure] Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.

💬 Medication Guide ~3 min read ▾

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: · Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: · with increasing doses of NSAIDs · with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.

You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. · Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: · anytime during use · without warning symptoms · that may cause death The risk of getting an ulcer or bleeding increases with: · past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs · taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” · increasing doses of NSAIDs · longer use of NSAIDs · smoking · drinking alcohol · older age · poor health · advanced liver disease · bleeding problems NSAIDs should only be used: · exactly as prescribed · at the lowest dose possible for your treatment · for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: · if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. · right before or after heart bypass surgery.

Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: · have liver or kidney problems · have high blood pressure · have asthma · are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. · are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? · new or worse high blood pressure · heart failure · liver problems including liver failure · kidney problems including kidney failure · low red blood cells (anemia) · life-threatening skin reactions · life threatening allergic reactions · Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: · shortness of breath or trouble breathing · chest pain · weakness in one part or side of your body · slurred speech · swelling of the face or throat Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: · nausea · more tired or weaker than usual · diarrhea · itching · your skin or eyes look yellow · indigestion or stomach pain · flu-like symptoms · vomit blood · there is blood in your bowel movement or it is black and sticky like tar · unusual weight gain · skin rash or blisters with fever · swelling of the arms, legs, hands and feet If you take too much of your NSAID, call…

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.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

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

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alopecia: Loss of hair from the scalp or body.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

apnea: A pause or temporary stop in breathing.

aseptic meningitis: Swelling of the membranes around the brain and spinal cord that is not caused by common bacteria.

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

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

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.

conjunctivitis: Redness and irritation of the thin lining over the white of the eye, often called pink eye.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

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

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

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

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

diplopia: Double vision, or seeing two images of a single object.

dose-response: The relationship between the size of a dose and the strength of the body's reaction to it.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

enzyme induction: When a substance makes the body produce more of an enzyme, speeding up how fast certain drugs are removed.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

epistaxis: A nosebleed.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

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

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

gastritis: Swelling or irritation of the lining of the stomach.

gynecomastia: Swelling or enlargement of breast tissue in males.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hematocrit: A blood test showing what share of your blood is made up of red blood cells.

hematuria: Blood in the urine.

hemoglobin: The iron-containing protein inside red blood cells that carries oxygen throughout the body.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

ischemia: Reduced blood flow to a part of the body, so that area does not get enough oxygen.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

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

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

melena: Black, sticky, tar-like stools caused by blood that has been digested higher up in the gut.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

nystagmus: Rapid, involuntary back-and-forth movements of the eyes that a person cannot control.

optic neuritis: Swelling and irritation of the nerve that carries signals from the eye to the brain, which can affect vision.

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

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

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

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

pruritus: Itching of the skin.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

serum sickness: A delayed reaction, usually one to two weeks after exposure, causing fever, rash, and joint pain as the body reacts to a foreign substance.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

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

urticaria: Raised, itchy welts on the skin, commonly called hives.

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 ↗

← 61919-0435-30 · Direct 61919-0469-30 · Direct →

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.

IBUPROFEN IBUOROFEN 800 mg Tablet, Film Coated, 60-count

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