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ibuprofen 600 mg Tablet, 90-count

by Proficient Rx LP · 90 TABLET in 1 BOTTLE (63187-451-90)

NDC 63187-0451-90

🏷️ FDA NDC (as labeled) 63187-451-90 billing pads the product segment with a zero

This package

Contains90-count Pack sizes4 compare ↓

Also priced by: Part D plans $0.1334/unit — full pricing hub ↓

Also comes in: 30 tablets 63187-0451-30 40 tablets 63187-0451-40 60 tablets 63187-0451-60

Rx only Generic On market Non-controlled

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

📋 All sources & update times →

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

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

⚠️

Other active recalls for Ibuprofen (different manufacturers) — 5 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Mar 2, 2026 — Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. (STRIDES PHARMA INC) · FDA recall D-0390-2026

Class III · Oct 29, 2024 — Failed Tablet/Capsule Specifications (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0047-2025

Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0644-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63187-451-90

Product NDC 63187-451

11-digit billing NDC 63187045190

NCPDP billing unit EA — each (per item)

RxCUI 197806

UNII WK2XYI10QM

Application # ANDA090796

SPL Set ID 924d2dd0-3b7d-42ec-b617-86729dba2b95

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 2012-02-22

Route ORAL

Dosage form TABLET

Substance IBUPROFEN

GPI-14 66100020000330

GPI class Ibuprofen

GCN Seq No 008349

GCN 35742

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 600 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 63187-451-90 — 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 → 63187-0451-90. 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

LabelerProficient Rx LP

Application holderMARKSANS PHARMA LTD

FDA applicationANDA090796 (ANDA)

Labeler code63187

First marketedFeb 2012

Product typeHuman Prescription Drug

Portfolio1,729 products on file

🔎 All NDCs from Proficient Rx LP

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 600 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

Some supplements/herbs that may interact with Ibuprofen — tap one for details:

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

🌿 Every supplement checked against Ibuprofen (286 interactions) — ranked by severity →

Nutrient depletion considerations

Ibuprofen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

FOLIC ACID Insufficient Evidence

🧪 Full Ibuprofen nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white

ShapeCapsule

Imprint122

Size18 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 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 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

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

Why might an inactive ingredient be missing?

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

Can inactive ingredients matter?

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

💲 Pricing

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

Price 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 · Q2 2026	$0.1334	$12.01 / 90 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ibuprofen 600 mg 42543-0965-07	Strides	500 tablets	$0.044	AB	Discontinued	—
Ibuprofen 600 mg 00904-5854-40	Major	500 tablets	$0.047	AB	Availability likely	—
Ibuprofen 600 mg 00904-7588-40	Major	500 tablets	$0.047	AB	Availability likely	—
Ibuprofen 600 mg 49483-0603-01	TIME	100 tablets	$0.047	AB	Availability likely	—
Ibu 600 mg 55111-0683-01	Dr.	100 tablets	$0.047	AB	Availability likely	—
Ibuprofen 600 mg 59651-0361-01	Aurobindo	100 tablets	$0.047	—	Availability likely	—
Ibuprofen 600 mg 60687-0457-01	American	100 tablets	$0.047	AB	Availability likely	—
Ibuprofen 600 mg 62135-0401-12	Chartwell	120 tablets	$0.047	—	Availability likely	—
Ibuprofen 600 mg 64380-0808-06	Strides	100 tablets	$0.047	AB	Availability likely	—
Ibuprofen 600 mg 67877-0320-01	Ascend	100 tablets	$0.047	AB	Availability likely	—
Ibuprofen 600 mg 68645-0562-59	Legacy	60 tablets	$0.047	AB	Availability likely	—
Ibuprofen 600 mg 69367-0395-01	Westminster	100 tablets	$0.047	—	Availability likely	—
Ibuprofen 600 mg 76282-0713-10	EXELAN	100 tablets	$0.047	AB	Availability likely	—
Ibuprofen 600 mg 71921-0181-01	Florida	100 tablets	$0.052	AB	FDA listed	—
Ibuprofen 600 mg 69238-1102-05	Amneal	500 tablets	$0.059	AB	FDA listed	—
Ibuprofen 600 mg 00615-8310-39	NCS	30 tablets	—	AB	Discontinued	—
Ibuprofen 600 mg 11788-0009-00	AiPing	22600 tablets	—	—	Discontinued	—
Ibuprofen 600 mg 25000-0122-03	MARKSANS	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 42708-0097-30	QPharma,	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 42708-0175-30	QPharma	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 43063-0867-01	PD-Rx	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 50090-2625-00	A-S	10 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 50090-2626-00	A-S	15 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 50090-2629-00	A-S	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 50090-5433-01	A-S	21 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 50090-5435-00	A-S	10 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 50090-7286-00	A-S	15 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 50090-7288-00	A-S	10 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 50090-7321-00	A-S	30 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 51407-0840-01	Golden	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 51655-0042-20	Northwind	20 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 51655-0474-20	Northwind	20 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 53746-0132-01	Amneal	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 53746-0465-01	Amneal	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 54348-0830-00	PharmPak,	1 tablet	—	AB	FDA listed	—
Ibuprofen 600 mg 55154-0741-00	Cardinal	1 tablet	—	AB	FDA listed	—
Ibupak 59088-0756-00	PureTek	100 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 60760-0597-20	ST.	20 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 60760-0603-20	St.	20 tablets	—	AB	Discontinued	—
Ibuprofen 600 mg 62207-0355-42	Granules	50 tablets	—	AB	FDA listed	—
ibuprofen 600 mgthis 63187-0451-90	Proficient	90 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 63187-0527-20	Proficient	20 tablets	—	AB	FDA listed	—
Ibu 600 mg 63187-0614-15	Proficient	15 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 63187-0980-15	Proficient	15 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 65162-0465-03	Amneal	30 tablets	—	AB	FDA listed	—
Ibu 600 mg 66267-0964-00	NuCare	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 67046-1646-03	Coupler	30 tablets	—	—	FDA listed	—
Ibu 600 mg 67296-0913-01	RedPharm	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 67296-2181-01	Redpharm	10 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 68071-2947-01	NuCare	21 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68071-2998-06	NuCare	6 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68071-3679-01	NuCare	100 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 68071-3778-02	NuCare	20 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 68071-3849-04	NuCare	4 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 68071-4009-01	NuCare	21 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68071-4243-01	NuCare	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68071-4459-06	NuCare	6 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68071-4887-03	NuCare	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68071-4968-03	NuCare	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68071-5066-04	NuCare	4 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68788-8354-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68788-8531-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68788-8754-01	Preferred	100 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 68788-9111-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 69367-0448-01	Westminster	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 70010-0067-88	Granules	15000 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 70518-0761-00	REMEDYREPACK	20 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 70518-1364-01	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Ibuprofen 600 mg 70518-2902-00	REMEDYREPACK	30 tablets	—	—	Discontinued	—
Ibuprofen 600 mg 70518-3313-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 70518-4341-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71205-0522-06	Proficient	6 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71335-1207-00	Bryant	21 tablets	—	AB	Discontinued	—
Ibuprofen 600 mg 71335-1218-00	Bryant	21 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71335-1503-00	Bryant	21 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71335-2683-00	Bryant	21 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71335-3121-00	Bryant	21 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 71610-0222-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibu 600 mg 71610-0501-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71610-0532-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibu 600 mg 71610-0547-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71610-0629-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71610-0891-53	Aphena	60 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71610-0895-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 71610-0902-53	Aphena	60 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 71610-0968-53	Aphena	60 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 72189-0231-21	DIRECT	21 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 72189-0643-21	Direct_Rx	21 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 72603-0909-01	NorthStar	500 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 72789-0187-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 72789-0212-06	PD-Rx	6 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 72789-0363-01	PD-Rx	100 tablets	—	AB	FDA listed	—
ibuprofen 600 mg 73086-0211-01	SKYA	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 75907-0330-91	Dr.	2000 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 76420-0576-01	Asclemed	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 76420-0847-01	Asclemed	100 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 80425-0132-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 80425-0154-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 80425-0424-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 80425-0426-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 80425-0553-01	Advanced	30 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 83008-0066-30	Quality	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 83615-0001-03	Bryant	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 87441-0044-01	Unit	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 85766-0219-01	Sportpharm	100 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 85534-0012-00	HAWAII	30 tablets	—	AB	FDA listed	—
Ibuprofen 600 mg 68788-4140-01	Preferred	100 tablets	—	—	FDA listed	—
Ibuprofen 600 mg 70518-4741-00	REMEDYREPACK	1 tablet	—	AB	FDA listed	—
Ibuprofen 600 mg 67877-0738-01	Ascend	100 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

🏛️

2012

On the market since

Feb 2012

📍

2026

Currently FDA-listed

14 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 — the ingredient across all brands.

Top reported reactions

Pain19,495

Fatigue18,755

Nausea18,290

Headache16,566

Arthralgia13,469

Dyspnoea13,139

Vomiting13,046

Age at onset

Neonate657

Infant880

Child2,279

Adolescent1,596

Adult26,531

Elderly8,944

Reporter sex

Male · 34%

Female · 65%

Unknown · 1%

Serious outcomes

Hospitalization85,488

Death18,734

Life-threatening14,904

Disabling11,119

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
63187-0451-30	30 TABLET in 1 BOTTLE (63187-451-30)	2019-01-01	Active
63187-0451-40	40 TABLET in 1 BOTTLE (63187-451-40)	2019-01-01	Active
63187-0451-60	60 TABLET in 1 BOTTLE (63187-451-60)	2019-01-01	Active
63187-0451-90 You're viewing this	90 TABLET in 1 BOTTLE (63187-451-90)	2019-01-01	Active

You're viewing the largest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0451-90?

NDC 63187-0451-90 is a 90-count package — 90 tablet in 1 bottle.

What is the difference between NDC 63187-0451-90 and NDC 63187-0451-30?

Both are ibuprofen 600 mg Tablet — the drug itself is identical. NDC 63187-0451-90 is the 90-count package, while NDC 63187-0451-30 is the 30 tablets package.

What NDC number is used to bill for this package of ibuprofen 600 mg Tablet?

Bill NDC 63187-0451-90 — the 11-digit billing format is 63187045190. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

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

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

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

Questions about this listing

Why is there no price listed?

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

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

Yes, they identify this exact package in different formats. The FDA registers it as 63187-451-90, 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: 63187-0451-90, written without dashes as 63187045190. 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 63187-0451-90, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0451) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) 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 Proficient Rx LP. 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 3 other package presentations of this same product, including 30 tablets (63187-0451-30), 40 tablets (63187-0451-40), 60 tablets (63187-0451-60). 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?

Proficient Rx LP 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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning 124 words ▾

Cardiovascular Risk • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS ). • Ibuprofen tablets are contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see 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 97 words ▾

INDICATIONS AND USAGE 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 ). 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 ▾

DOSAGE AND ADMINISTRATION 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-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid).

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 four 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 79 words ▾

CONTRAINDICATIONS Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, 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, and PRECAUTIONS, Preexisting Asthma ).

Ibuprofen tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

⚠️ Warnings ~3 min read ▾

WARNINGS

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, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk.

To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or 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 does increase the risk of serious GI events (see WARNINGS, Gastrointestinal Effects-Risk of Ulceration, Bleeding, and Perforation ). 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 (see CONTRAINDICATIONS ).

Hypertension NSAIDs including ibuprofen tablets, can lead to onset of new hypertension or worsening of pre-existing 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. Congestive Heart Failure and Edema Fluid retention and edema have been observed in some patients taking NSAIDs. Ibuprofen tablets should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation NSAIDs, including ibuprofen tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic.

Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients treated with neither of these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.

Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS 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 Unknown* Precise Incidence Unknown (but less than 1%) Probable Causal Relationship* Precise Incidence Unknown (but less than 1%) Causal Relationship 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 lability, 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 (eg 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, elevated blood pressure, palpitations Arrhythmias (sinus tachycardia, sinus bradycardia) ALLERGIC Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS ) Serum sickness, lupuserythematosus syndrome.

Henoch-Schonlein vasculitis, angioedema RENAL Acute renal failure (see PRECAUTIONS ), decreased creatinine clearance, polyuria, azotemia, cystitis, Hematuria Renal papillary necrosis MISCELLANEOUS Dry eyes and mouth, gingival ulcer, rhinitis * Reactions are classified under “Probable Causal Relationship (PCR)” if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under “Causal Relationship Unknown” if seven…

🔄 Drug Interactions ~2 min read ▾

Drug Interactions ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. Aspirin When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen tablets is not altered.

The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects. Diuretics Clinical studies, as well as post marketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects ), as well as to assure diuretic efficacy. Lithium Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration.

This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.) Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.

This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate. Warfarin-type anticoagulants Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants.

However, because bleeding has been reported when ibuprofen tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. H-2 Antagonists In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

🤰 Pregnancy 127 words ▾

Pregnancy Teratogenic effects-Pregnancy Category C Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women.

Ibuprofen tablets should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects Because of the known effects of NSAIDs on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided. Labor and Delivery In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred.

The effects of ibuprofen tablets on labor and delivery in pregnant women are unknown.

🧒 Pediatric Use 15 words ▾

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

🧓 Geriatric Use 18 words ▾

Geriatric Use As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Approximately 1½ hours after the reported ingestion of from 7 to 10 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 μg/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 μg/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 ▾

CLINICAL PHARMACOLOGY 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< .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 a 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 in…

📦 How Supplied / Storage and Handling 95 words ▾

HOW SUPPLIED Ibuprofen tablets are available in the following strengths : 600 mg (White to off white, capsule shaped, biconvex, film coated tablets debossed with ‘122’ on one side and plain on other side) Bottles of 30 (NDC 63187-451-30) Bottles of 40 (NDC 63187-451-40) Bottles of 60 (NDC 63187-451-60) Bottles of 90 (NDC 63187-451-90) Store at 20° to 25°C(68° to 77°F)[see USP Controlled Room Temperature] Rx only Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Marksans Pharma Ltd. Verna, Goa-403 722, India Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev.

07/13

📋 Description 100 words ▾

DESCRIPTION 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 tablets, a nonsteroidal anti-inflammatory drug (NSAID), are available in 400 mg, 600 mg, and 800 mg tablets for oral administration.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc and titanium dioxide. Structural Formula

💬 Information for Patients ~2 min read ▾

Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. • Ibuprofen tablets like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms.

Patients should be apprised of the importance of this follow-up (see WARNINGS, Cardiovascular Effects ). • Ibuprofen tablets, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative signs or symptoms including epigastric pain, dyspepsia, melena, and hematemesis.

Patients should be apprised of the importance of this follow-up (see WARNINGS, Gastrointestinal Effects- Risk of Ulceration, Bleeding and Perforation ). • Ibuprofen tablets, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS and TEN, which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs hypersensitivity such as itching, and should ask for medical advice when observing any indicative sign or symptoms.

Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible. • Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians. • Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and “flu-like” symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. • Patients should be informed of the signs of an anaphylactoid reaction (e.g. difficulty breathing, swelling of the face or throat).

If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS ). • In late pregnancy, as with other NSAIDs, ibuprofen tablets should be avoided because it may cause premature closure of the ductus arteriosus.

💬 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 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: • with longer use of NSAID medicines • in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment.

Ulcers and bleeding: • can happen without warning symptoms • may cause death The chance of a person getting an ulcer or bleeding increases with: • taking medicines called “corticosteroids” and “anticoagulants” • longer use • smoking • drinking alcohol • older age • having poor health NSAID medicines should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine: • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine • for pain right before or after heart bypass surgery Tell your healthcare provider: • about all your medical conditions • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. • if you are pregnant.

NSAID medicines should not be used by pregnant women late in their pregnancy. • if you are breastfeeding. Talk to your doctor. What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include: • heart attack • stroke • high blood pressure • heart failure from body swelling (fluid retention) • kidney problems including kidney failure • bleeding and ulcers in the stomach and intestine • low red blood cells (anemia) • life-threatening skin reactions • life-threatening allergic reactions • liver problems including liver failure • asthma attacks in people who have asthma • stomach pain • constipation • diarrhea • gas • heartburn • nausea • vomiting • dizziness Get emergency help right away if you have 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 your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: • nausea • more tired or weaker than usual • itching • your skin or eyes look yellow • 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 and legs, hands and feet These are not all the side effects with NSAID medicines.

Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines.

Aspirin can also cause ulcers in the stomach and intestines. • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. NSAID medicines that need a prescription Ge…

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.

synergistic: When two things taken together produce a larger effect than adding their separate effects would predict.

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 event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

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.

anaphylactoid reaction: A severe reaction that looks like a serious allergic reaction but is not caused by the usual allergy antibodies.

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.

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

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.

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

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.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

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

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

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

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

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.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

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.

emotional lability: Rapid, exaggerated mood changes that shift quickly from one feeling to another.

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.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

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

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

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

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.

hematemesis: Vomiting blood, which may look bright red or like dark coffee grounds.

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.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

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.

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

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

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

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

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.

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

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.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

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

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

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.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

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.

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

← 63187-0450-20 · Proficient 63187-0452-03 · Proficient →

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 600 mg Tablet, 90-count

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