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Ibuprofen 400 mg Tablet, 45-count — NDC 63187-0489-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ibuprofen 400 mg Tablet, 45-count — NDC 63187-489-45 (Billing 63187-0489-45)

by Proficient Rx LP · 45 TABLET in 1 BOTTLE

This is a package of 45 tablets of Ibuprofen 400 mg Tablet from Proficient Rx LP, marketed since Nov 2009 and currently FDA-listed.

NDC 63187-0489-45
🏷️ FDA NDC (as labeled) 63187-489-45 billing pads the product segment with a zero
This package
Contains45-count Pack sizes7 compare ↓
Also priced by: Part D plans $0.1334/unit — full pricing hub ↓
Product page 63187-0489-20 Also comes in: 20 tablets 63187-489-20 30 tablets 63187-489-30 40 tablets 63187-489-40 60 tablets 63187-489-60 90 tablets 63187-489-90 120 tablets 63187-489-72
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for 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
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-0646-2024
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-0645-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-489-45
Product NDC 63187-489
11-digit billing NDC 63187048945
RxCUI 197805, 197806, 197807
UNII WK2XYI10QM
Application # ANDA078558
SPL Set ID e23eb275-ce0c-40ec-b809-a48c5e46c7ec
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 2009-11-23
Route ORAL
Dosage form TABLET
Substance IBUPROFEN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 008348
GCN 35741
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 400 MG TABLET
FDB brand name Ibuprofen
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008348
  • GCN: 35741
  • HICL (First Databank): 003723
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 197805
Why two NDCs? The FDA registers this code as 63187-489-45 — 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 → 63187-0489-45. 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.

Clinical

Label name IBUPROFEN 400 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
  • Over-the-counter ibuprofen helps with minor aches and pains like headache, toothache, backache, muscle aches, cramps and cold symptoms, and it lowers fever. Prescription versions a...
  • If ibuprofen upsets your stomach, take it with food or milk. Use the lowest dose that works for the shortest time you need.
  • The more common ones are nausea, vomiting, gas, headache and dizziness. These are usually manageable, but tell me if they bother you.
  • Stop and get help if you have black or bloody stools, vomit blood, chest pain, trouble breathing, weakness on one side, slurred speech, a skin rash, or swelling of the face. Also c...
📖 Read our full Ibuprofen guide →
1
Nutrient depletion considerations

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

🧪 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.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1334 $6.00 / 45 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0489-20 63187-489-20 Main listing 20 TABLET in 1 BOTTLE 2016-09-01 — Active
63187-0489-30 63187-489-30 30 TABLET in 1 BOTTLE 2015-05-01 — Active
63187-0489-40 63187-489-40 40 TABLET in 1 BOTTLE 2015-05-01 — Active
63187-0489-45 You're viewing this 45 TABLET in 1 BOTTLE 2015-05-01 — Active
63187-0489-60 63187-489-60 60 TABLET in 1 BOTTLE 2015-05-01 — Active
63187-0489-72 63187-489-72 120 TABLET in 1 BOTTLE 2015-05-01 — Active
63187-0489-90 63187-489-90 90 TABLET in 1 BOTTLE 2015-05-01 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 45-count package — 45 tablet in 1 bottle.
How does this package differ from NDC 63187-0489-20?
Both are Ibuprofen 400 mg Tablet — the drug itself is identical. This page's package is the 45-count one, while NDC 63187-0489-20 is the 20 tablets package.
What NDC number is used to bill for this package of Ibuprofen 400 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ibuprofen 400 mg 00904-5853-40 Major 500 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 00904-7587-40 Major 500 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 42543-0966-07 Strides 500 tablets $0.039 AB Discontinued —
Ibuprofen 400 mg 49483-0602-01 TIME 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 55111-0682-01 Dr. 100 tablets $0.039 — Availability likely —
Ibuprofen 400 mg 59651-0360-01 Aurobindo 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 60687-0446-01 American 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 62135-0400-12 Chartwell 120 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 64380-0809-06 Strides 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 67877-0319-01 Ascend 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 69367-0394-01 Westminster 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 70010-0066-01 Granules 100 tablets $0.039 — Availability likely —
Ibuprofen 400 mg 76282-0712-10 EXELAN 100 tablets $0.039 AB Availability likely —
Ibuprofen 400 mg 69238-1101-05 Amneal 500 tablets $0.048 AB FDA listed —
Ibuprofen 400 mg 71921-0180-01 Florida 100 tablets $0.049 AB FDA listed —
Ibuprofen 400 mg 00615-8309-39 NCS 30 tablets — AB FDA listed —
Ibuprofen 400 mg 11788-0008-00 AiPing 34000 tablets — AB Discontinued —
Ibuprofen 400 mg 25000-0121-03 MARKSANS 30 tablets — AB FDA listed —
Ibuprofen 400 mg 43063-0872-06 PD-Rx 6 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-2996-00 A-S 16 tablets — AB Discontinued —
Ibuprofen 400 mg 50090-3007-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-5818-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-5819-00 A-S 16 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-6676-00 A-S 16 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-6677-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-7788-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 400 mg 50090-7789-00 A-S 16 tablets — AB FDA listed —
Ibu 400 mg 51407-0369-05 Golden 500 tablets — AB FDA listed —
Ibuprofen 400 mg 51407-0839-01 Golden 100 tablets — AB FDA listed —
Ibuprofen 400 mg 51655-0048-26 Northwind 90 tablets — AB FDA listed —
Ibuprofen 400 mg 51655-0759-52 Northwind 30 tablets — AB FDA listed —
Ibuprofen 400 mg 53746-0131-01 Amneal 100 tablets — AB FDA listed —
Ibuprofen 400 mg 53746-0464-01 Amneal 100 tablets — AB FDA listed —
Ibuprofen 400 mg 54348-0835-00 PharmPak, 1 tablet — AB FDA listed —
Ibuprofen 400 mg 55154-1380-00 Cardinal 1 tablet — AB FDA listed —
Ibuprofen 400 mg 62207-0354-42 Granules 50 tablets — AB FDA listed —
Ibuprofen 400 mgthis 63187-0489-45 Proficient 45 tablets — AB FDA listed —
Ibuprofen 400 mg 63187-0967-15 Proficient 15 tablets — AB FDA listed —
Ibuprofen 400 mg 63629-1468-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 65162-0464-03 Amneal 30 tablets — AB FDA listed —
Ibuprofen 400 mg 67296-2184-02 Redpharm 20 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-2939-04 NuCare 4 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-3442-03 NuCare 30 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-3507-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-4952-04 NuCare 40 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-5126-03 NuCare 30 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-5134-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 400 mg 68071-5228-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 400 mg 68788-4039-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 400 mg 68788-8438-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 400 mg 68788-9110-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 400 mg 69367-0447-01 Westminster 100 tablets — AB FDA listed —
Ibuprofen 400 mg 70518-1051-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 400 mg 70518-2432-01 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 400 mg 70518-3861-00 REMEDYREPACK 30 tablets — AB Discontinued —
Ibuprofen 400 mg 71205-0464-15 Proficient 15 tablets — AB FDA listed —
Ibu 400 mg 71205-0604-15 Proficient 15 tablets — AB FDA listed —
Ibuprofen 400 mg 71335-0690-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 71335-1270-01 Bryant 20 tablets — AB Discontinued —
Ibuprofen 400 mg 71335-1517-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 71335-2682-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 71610-0916-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 400 mg 71610-0969-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 400 mg 72189-0324-30 Direct 30 tablets — AB FDA listed —
Ibuprofen 400 mg 72189-0564-30 Direct_rx 30 tablets — AB FDA listed —
Ibuprofen 400 mg 72789-0185-20 PD-Rx 20 tablets — AB FDA listed —
Ibuprofen 400 mg 72789-0201-06 PD-Rx 6 tablets — AB FDA listed —
ibuprofen 400 mg 73086-0210-01 SKYA 100 tablets — AB FDA listed —
Ibuprofen 400 mg 75907-0331-94 Dr. 4000 tablets — — FDA listed —
Ibuprofen 400 mg 76420-0575-01 Asclemed 100 tablets — AB FDA listed —
Ibuprofen 400 mg 76420-0846-01 Asclemed 100 tablets — AB FDA listed —
Ibuprofen 400 mg 82804-0137-15 Proficient 15 tablets — AB FDA listed —
Ibuprofen 400 mg 83209-0464-09 Boswell 9 tablets — AB FDA listed —
Ibuprofen 400 mg 85534-0011-00 HAWAII 30 tablets — AB FDA listed —
Ibuprofen 400 mg 85766-0218-01 Sportpharm 100 tablets — AB FDA listed —
Ibuprofen 400 mg 63629-7676-01 Bryant 20 tablets — AB FDA listed —
Ibuprofen 400 mg 55154-2583-00 Cardinal 10 tablets — AB FDA listed —
Ibuprofen 400 mg 72789-0590-30 PD-Rx 30 tablets — AB FDA listed —
Ibuprofen 400 mg 67877-0737-01 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

🏛️
2009
On the market since
Nov 2009
📍
2026
Currently FDA-listed
17 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.

What it looks like

Color White
ShapeOval
ImprintIP;466
Size19 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerProficient Rx LP
Application holderAMNEAL PHARMACEUTICALS NY LLC
FDA applicationANDA078558 (ANDA)
Labeler code63187
First marketedNov 2009
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 ⚠️ Precautions 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 121 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 103 words ▾

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

Ibuprofen Tablets, USP are indicated for relief of mild to moderate pain. Ibuprofen Tablets, USP are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets, USP 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, USP 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 78 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 GI WARNINGS). 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 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. 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 a NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs a… [Excerpted — this section continues on DailyMed.]

🤒 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 Precise Incidence Unknown (but less than 1%) Probable Causal Relationship** Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown** * Reactions occurring in 3% to 9% of patients treated with ibuprofen tablets. (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 three or more cases occur which might be causally related.

Reactions are classified under “ Causal Relationship Unknown ” if seven or more events have been reported but the criteria for PCR have not been met. 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 neuritis, cataracts 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, lupus erythe-… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Approximately 1 ½ 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 8 ½ 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 51 Cr-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… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 209 words ▾

HOW SUPPLIED Ibuprofen Tablets, USP are available in the following strengths, colors and sizes: 400 mg (white, round, biconvex, aqueous film-coated tablets, debossed “IP 464” on obverse and plain on reverse. They are available as follows: Bottles of 20: NDC 63187-489-20 Bottles of 30: NDC 63187-489-30 Bottles of 40: NDC 63187-489-40 Bottles of 45: NDC 63187-489-45 Bottles of 60: NDC 63187-489-60 Bottles of 90: NDC 63187-489-90 Bottles of 120: NDC 63187-489-72 600 mg (white, oval-shaped, biconvex, aqueous film-coated tablets, debossed “IP 465” on obverse and plain on reverse.

They are available as follows: Bottles of 20: NDC 63187-527-20 Bottles of 30: NDC 63187-527-30 Bottles of 40: NDC 63187-527-40 Bottles of 45: NDC 63187-527-45 Bottles of 60: NDC 63187-527-60 Bottles of 90: NDC 63187-527-90 Bottles of 120: NDC 63187-527-72 800 mg (white, capsule-shaped, biconvex, aqueous film-coated tablets, debossed “IP 466” on obverse and plain on reverse. They are available as follows: Bottles of 15: NDC 63187-022-15 Bottles of 20: NDC 63187-022-20 Bottles of 21: NDC 63187-022-21 Bottles of 30: NDC 63187-022-30 Bottles of 40: NDC 63187-022-40 Bottles of 45: NDC 63187-022-45 Bottles of 60: NDC 63187-022-60 Bottles of 90: NDC 63187-022-90 Bottles of 120: NDC 63187-022-72 Store at controlled room temperature 20° to 25°C (68° to 77°F)[see USP].

Rx only

📋 Description 105 words ▾

DESCRIPTION Ibuprofen Tablets, USP 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, USP, 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, and titanium dioxide. 56fb8872-figure-01

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Ibuprofen tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of ibuprofen tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Hepatic effects Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, including ibuprofen tablets. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy.

Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ibuprofen tablets.

If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen tablets should be discontinued. Hematological effects Anemia is sometimes seen in patients receiving NSAIDs, including ibuprofen tablets. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis.

Patients on long-term treatment with NSAIDs, including ibuprofen tablets, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia. In two postmarketing clinical studies the incidence of a decreased hemoglobin level was greater than previously reported. Decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients on 1600 mg ibuprofen daily (osteoarthritis), and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily (rheumatoid arthritis).

Positive stool occult blood tests and elevated serum creatinine levels were also observed in these studies. NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible.

Patients receiving ibuprofen tablets who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants should be carefully monitored. Preexisting asthma Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal.

Since cross reactivity, including bronchospasm, between aspirin and NSAIDs has been reported in such aspirin-sensitive patients, ibuprofen tablets should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma. Ophthalmological effects Blurred and/or diminished vision, scotomata, and/or changes in color vision have been reported. If a patient develops such complaints while receiving ibuprofen tablets, the drug should be discontinued, and the patient should have an ophthalmologic examination which includes central visual fields and color vision testing.

Aseptic meningitis Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do n… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 13 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 63187-022-30

Package/Label Display Panel 63187-489-20

Package/Label Display Panel 63187-527-30

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

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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 6 other package presentations of this same product, including 20 tablets (63187-0489-20), 30 tablets (63187-0489-30), 40 tablets (63187-0489-40). 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.
← 63187-0488-14 · Proficient 63187-0490-10 · 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.