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Ibuprofen 800 mg Tablet, Film Coated, 120-count

by Aphena Pharma Solutions - Tennessee, LLC · 120 TABLET, FILM COATED in 1 BOTTLE (71610-901-70)

NDC 71610-0901-70

🏷️ FDA NDC (as labeled) 71610-901-70 billing pads the product segment with a zero

This package

Contains120-count Pack sizes4 compare ↓

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

Also comes in: 90 tablets 71610-0901-60 180 tablets 71610-0901-80 270 tablets 71610-0901-92

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) 71610-901-70

Product NDC 71610-901

11-digit billing NDC 71610090170

NCPDP billing unit EA — each (per item)

RxCUI 197807

UNII WK2XYI10QM

Application # ANDA202413

SPL Set ID 34673d3b-41cd-f4c9-e063-6394a90a8510

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 2024-05-23

Route ORAL

Dosage form TABLET, FILM COATED

Substance IBUPROFEN

GCN Seq No 008350

GCN 35744

HICL code 003723

Ingredient (HICL) Ibuprofen

HIC1 code S

Therapeutic class — broad (HIC1) Locomotor System

HIC2 code S2

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

HIC3 code S2B

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

AHFS code 28:08.04.04

AHFS class Reversible Cox-1/Cox-2 Inhibitors

FDB label name IBUPROFEN 800 MG TABLET

FDB brand name Ibuprofen

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 71610-901-70 — 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 → 71610-0901-70. 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

LabelerAphena Pharma Solutions - Tennessee, LLC

Application holderSHANDONG XINHUA PHARMACEUTICAL CO LTD

FDA applicationANDA202413 (ANDA)

Labeler code71610

First marketedMay 2024

Product typeHuman Prescription Drug

Portfolio795 products on file

🔎 All NDCs from Aphena Pharma Solutions - Tennessee, LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name IBUPROFEN 800 MG TABLET Ingredient Ibuprofen

📗 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

ShapeOval

ImprintBI8

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.

💡 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 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 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

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

Why might an inactive ingredient be missing?

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

Can inactive ingredients matter?

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

💲 Pricing

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

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.1334	$16.01 / 120 tablets

Where does this data come from?

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

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ibuprofen 800 mg 42543-0964-07	Strides	500 tablets	$0.057	AB	Discontinued	—
Ibuprofen 800 mg 00904-5855-40	Major	500 tablets	$0.059	AB	Availability likely	—
Ibuprofen 800 mg 49483-0604-01	TIME	100 tablets	$0.059	AB	Availability likely	—
Ibuprofen 800 mg 55111-0684-01	Dr.	100 tablets	$0.059	—	Availability likely	—
Ibuprofen 800 mg 59651-0362-01	Aurobindo	100 tablets	$0.059	AB	Availability likely	—
Ibuprofen 800 mg 60687-0468-01	American	100 tablets	$0.059	AB	Availability likely	—
Ibuprofen 800 mg 62135-0402-12	Chartwell	120 tablets	$0.059	—	Availability likely	—
Ibuprofen 800 mg 64380-0807-06	Strides	100 tablets	$0.059	AB	Availability likely	—
Ibuprofen 800 mg 67877-0321-01	Ascend	100 tablets	$0.059	—	Availability likely	—
Ibuprofen 800 mg 68645-0563-54	Legacy	30 tablets	$0.059	AB	Availability likely	—
Ibuprofen 800 mg 69367-0396-01	Westminster	100 tablets	$0.059	—	Availability likely	—
Ibuprofen 800 mg 70512-0780-10	SOLA	100 tablets	$0.059	AB	Availability likely	—
Ibuprofen 800 mg 76282-0714-10	EXELAN	100 tablets	$0.059	AB	Availability likely	—
Ibuprofen 800 mg 71921-0182-01	Florida	100 tablets	$0.066	AB	FDA listed	—
Ibuprofen 800 mg 69238-1103-05	Amneal	500 tablets	$0.074	AB	FDA listed	—
Ibuprofen 800 mg 00615-8311-39	NCS	30 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 00904-7592-40	Major	500 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 11788-0010-00	AiPing	17000 tablets	—	—	Discontinued	—
Ibuprofen 800 mg 25000-0123-03	MARKSANS	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 43063-0914-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-2548-00	A-S	10 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 50090-2549-00	A-S	4 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-2597-00	A-S	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-5444-04	A-S	28 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-5445-00	A-S	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-5446-00	A-S	10 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-6616-00	A-S	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-6645-00	A-S	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-6886-00	A-S	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 50090-7281-05	A-S	90 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 50090-7282-00	A-S	90 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 50090-7283-00	A-S	10 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 50090-7320-00	A-S	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 50090-7905-00	A-S	500 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 51407-0841-01	Golden	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 51655-0275-20	Northwind	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 51655-0385-20	Northwind	20 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 53746-0137-01	Amneal	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 53746-0466-01	Amneal	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 54348-0825-00	PharmPak,	1 tablet	—	AB	FDA listed	—
Ibuprofen 800 mg 55154-1342-00	Cardinal	1 tablet	—	AB	FDA listed	—
Ibuprofen 800 mg 60760-0596-20	St.	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 60760-0604-00	St.	100 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 60760-0844-20	ST.	20 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 60760-0929-20	St.	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 61919-0463-30	Direct_Rx	30 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 62207-0356-42	Granules	50 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 63187-0022-15	Proficient	15 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 63187-0962-20	Proficient	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 63187-0992-15	Proficient	15 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 63629-1470-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 65162-0466-03	Amneal	30 tablets	—	AB	FDA listed	—
Ibu 800 mg 66267-0963-00	NuCare	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 67046-1214-03	Coupler	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 67046-1606-03	Coupler	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 67296-2196-01	Redpharm	10 tablets	—	—	FDA listed	—
Ibu 800 mg 68071-3053-00	NuCare	12 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-3362-00	NuCare	12 tablets	—	AB	Discontinued	—
Ibuprofen 800 mg 68071-3415-06	NuCare	6 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-3552-03	NuCare	3 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-3696-08	NuCare	180 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-3793-01	NuCare	21 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 68071-3966-06	NuCare	6 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 68071-4845-01	NuCare	21 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-4949-03	NuCare	3 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-5135-00	NuCare	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68071-5140-03	NuCare	3 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68788-8319-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68788-8710-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68788-8757-01	Preferred	100 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 68788-9112-01	Preferred	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 69367-0449-01	Westminster	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70010-0068-89	Granules	11400 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-0176-02	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-1409-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-3178-00	REMEDYREPACK	15 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-4010-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 70518-4259-00	REMEDYREPACK	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 71335-1073-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71335-1206-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71335-1396-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71335-2689-00	Bryant	84 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71335-3108-01	Bryant	500 tablets	—	AB	FDA listed	—
Ibu 800 mg 71610-0550-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0890-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0892-53	Aphena	60 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0897-53	Aphena	60 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 71610-0898-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mgthis 71610-0901-70	Aphena	120 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 71610-0967-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72189-0266-15	DIRECT	15 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72189-0556-20	Direct_Rx	20 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72603-0910-01	NorthStar	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0186-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0200-10	PD-Rx	10 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0218-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0364-10	PD-Rx	10 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0382-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 72789-0565-15	PD-Rx	15 tablets	—	—	FDA listed	—
ibuprofen 800 mg 73086-0212-01	SKYA	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 73614-0201-03	Brisk	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 75907-0329-89	Dr.	1500 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 76420-0415-01	Asclemed	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 76420-0577-01	Asclemed	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 76420-0848-01	Asclemed	100 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 80425-0046-01	Advanced	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0047-01	Advanced	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0089-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0243-04	Advanced	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0393-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 80425-0537-01	Advanced	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 82804-0227-15	Proficient	15 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 82804-0293-24	Proficient	24 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 82868-0069-30	Northwind	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 83008-0050-30	Quality	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 85509-1466-03	PHOENIX	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 85509-2396-03	PHOENIX	30 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 87441-0045-01	Unit	30 tablets	—	AB	FDA listed	—
Ibu 800 mg 71610-0275-60	Aphena	90 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 85534-0013-00	HAWAII	30 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 85766-0220-01	Sportpharm	100 tablets	—	AB	FDA listed	—
Ibuprofen 800 mg 68788-4139-01	Preferred	100 tablets	—	—	FDA listed	—
Ibuprofen 800 mg 72789-0584-30	PD-Rx	30 tablets	—	—	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

🏛️

2024

On the market since

May 2024

📍

2026

Currently FDA-listed

2 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
71610-0901-60	90 TABLET, FILM COATED in 1 BOTTLE (71610-901-60)	2025-05-01	Active
71610-0901-70 You're viewing this	120 TABLET, FILM COATED in 1 BOTTLE (71610-901-70)	2025-05-01	Active
71610-0901-80	180 TABLET, FILM COATED in 1 BOTTLE (71610-901-80)	2025-05-01	Active
71610-0901-92	270 TABLET, FILM COATED in 1 BOTTLE (71610-901-92)	2025-05-01	Active

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

Pack size FAQ

What quantity is in NDC 71610-0901-70?

NDC 71610-0901-70 is a 120-count package — 120 tablet, film coated in 1 bottle.

What is the difference between NDC 71610-0901-70 and NDC 71610-0901-60?

Both are Ibuprofen 800 mg Tablet, Film Coated — the drug itself is identical. NDC 71610-0901-70 is the 120-count package, while NDC 71610-0901-60 is the 90 tablets package.

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

Bill NDC 71610-0901-70 — the 11-digit billing format is 71610090170. 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
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NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

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

Questions about this listing

Why is there no price listed?

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

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 71610-901-70, 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: 71610-0901-70, written without dashes as 71610090170. 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 71610-0901-70, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0901) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (70) 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 Aphena Pharma Solutions - Tennessee, LLC. 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 90 tablets (71610-0901-60), 180 tablets (71610-0901-80), 270 tablets (71610-0901-92). 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?

Aphena Pharma Solutions - Tennessee, LLC 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 📦 Storage and Handling 📋 Description 💬 Information for Patients

🚨 Boxed Warning 115 words ▾

Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. [See WARNINGS and PRECAUTIONS ]. Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS and WARNINGS ].

Gastrointestinal Risk NSAIDS cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. [See WARNINGS ].

🎯 Indications and Usage 96 words ▾

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

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

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION 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 ]. After observing the response to initial therapy with Ibuprofen Tablets, USP, 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 (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 three tablet strengths facilitates dosage adjustment. In chronic conditions , a therapeutic response to therapy with Ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

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

⛔ Contraindications 74 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 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, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.

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

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

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

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

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

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

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

Additionally, fluid retent…

🤒 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 Reactions occurring in 3% to 9% of patients treated with ibuprofen tablets. (Those reactions occurring in less than 3% of the patients are unmarked.) Precise Incidence Unknown (but less than 1%) Probable Causal Relationship 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. Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown GASTROINTESTINAL Nausea , epigastric pain , heartburn , diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating or 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, pseudotumor 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, lupus erythematosus syndrome.

Henoch- Schonle…

🔄 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 Pharmacodynamic studies have demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with enteric-coated low-dose aspirin.

The interaction exists even following a once-daily regimen of ibuprofen 400 mg, particularly when ibuprofen is dosed prior to aspirin. The interaction is alleviated if immediate-release low-dose aspirin is dosed at least 2 hours prior to a once-daily regimen of ibuprofen; however, this finding cannot be extended to enteric-coated low-dose aspirin [see Clinical Pharmacology/Pharmacodynamics ]. Because there may be an increased risk of cardiovascular events due to the interference of ibuprofen with the antiplatelet effect of aspirin, for patients taking low-dose aspirin for cardio protection who require analgesics, consider use of a NSAID that does not interfere with the antiplatelet effect of aspirin, or non-NSAID analgesics, where appropriate.

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 PRECAUTIONS, 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 ~3 min read ▾

Pregnancy Risk Summary Use of NSAIDs, including Ibuprofen tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Ibuprofen tablets use between about 20 and 30 weeks of gestation, and avoid Ibuprofen tablets use at about 30 weeks of gestation and later in pregnancy [see WARNINGS; Fetal Toxicity ]. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including Ibuprofen tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. 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. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as Ibuprofen, resulted in increased pre- and post-implantation loss.

Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including Ibuprofen tablets, can cause premature closure of the fetal ductus arteriosus [see WARNINGS; Fetal Toxicity ].

Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If Ibuprofen tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue Ibuprofen tablets and follow up according to clinical practice [see WARNINGS; Fetal Toxicity ].

Data Human Data There are no adequate, 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. Premature Closure of Fetal Ductus Arteriosus Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus.

Oligohydramnios/Neonatal Renal Impairment Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug.

There have been a limited number of case report…

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

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

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

🧬 Clinical Pharmacology ~3 min read ▾

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 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 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 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 aspirintreated patients.

In clinical studies in patients with rheumatoid arthritis, ibuprofen has 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 may be used in combination with gold salts and/or corticosteroids. Controlled studies have demonstrated that ibuprofen is 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 has 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. Pharmacodynamics In a healthy volunteer study, ibuprofen 400 mg given once daily, administered 2 hours prior to immediate-release aspirin (81 mg) for 6 days, showed an interaction with the antiplatelet activity of aspirin as measured by % serum thromboxane B2 (TxB2) inhibition at 24 hours following the day-6 aspirin dose [53%].

An interaction was still observed, but minimized, when ibuprofen 400 mg given once-daily was administered as early as 8 hours prior to the immediate-release aspirin dose [90.7%]. However, there was no interaction with the antiplatelet activity of aspirin when ibuprofen 400 mg, given once daily, was administered 2 hours after (but not concomitantly, 15 min, or 30 min after) the immediate-release aspirin dose [99.2%]. In another study, where immediate-release aspirin 81 mg was administered once daily with ibuprofen 400 mg given three times daily (1, 7, and 13 hours post-aspirin dose) for 10 consecutive days, the mean % serum thromboxane B2 (TxB2) inhibition suggested no interaction with the antiplatelet activity of aspirin [98.3%].

However, there were individual subjects with serum TxB2 inhibition below 95%, with the lowest being 90.2%. When a similarly designed study was conducted with enteric-coated aspirin, where healthy subjects were administered enteric-coated aspirin 81 mg once daily for 6 days and ibuprofen 400 mg three times daily (2, 7 and 12 h…

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED Ibuprofen tablets, USP are available in the following strengths, colors and sizes: 400 mg (white, oval shaped, debossed BI 4) Bottles of 100 NDC 69367-394-01 Bottles of 500 NDC 69367-394-05 600 mg (white, oval, debossed BI 6) Bottles of 100 NDC 69367-395-01 Bottles of 500 NDC 69367-395-05 800 mg (white, caplet, debossed BI 8) Bottles of 100 NDC 69367-396-01 Bottles of 500 NDC 69367-396-05 Store at 20°C - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F).

📦 Storage and Handling 18 words ▾

Store at 20°C - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F).

📋 Description 104 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, a nonsteroidal anti-inflammatory drug (NSAID), is available in 300 mg, 400 mg, 600 mg, and 800 mg tablets for oral administration.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, soidum starch glycoate, stearic acid, talc, titanium dioxide. Chemical Structure

💬 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. CARDIOVASCULAR THROMBOTIC EVENTS Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see WARNINGS ].

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 ].

Serious Skin Reactions, including DRESS: Advise patients to stop taking Ibuprofen tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see WARNINGS ]. Heart failure and Edema: Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see WARNINGS ]. 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. Fetal Toxicity Inform pregnant women to avoid use of Ibuprofen tablets and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with Ibuprofen tablets is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see WARNINGS; Fetal Toxicity , PRECAUTIONS; Pregnancy ].

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

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

case report: A written account of what happened to one patient, useful as a signal but not proof of cause.

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 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.

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.

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

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.

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

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

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

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.

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

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.

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

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

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

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

gynecomastia: Swelling or enlargement of breast tissue in males.

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.

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.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

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.

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

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

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.

neonatal: Relating to a newborn baby during its first four weeks of life.

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.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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 800 mg Tablet, Film Coated, 120-count

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