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IBU 600 mg Tablet, 30-count — NDC 67296-0913-01 package photo

IBU 600 mg Tablet, 30-count

by RedPharm Drug, Inc. · 30 TABLET in 1 BOTTLE (67296-0913-1)
NDC 67296-0913-01
🏷️ FDA NDC (as labeled) 67296-0913-1 billing pads the package segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1334/unit — full pricing hub ↓
Also comes in: 10 tablets 67296-0913-03 90 tablets 67296-0913-09
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

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

🆔 Identity & classification

FDA NDC (as labeled) 67296-0913-1
Product NDC 67296-0913
11-digit billing NDC 67296091301
RxCUI 197806
UNII WK2XYI10QM
UPC 0367296091311
Application # ANDA075682
SPL Set ID 4db219dc-ea48-490c-e054-00144ff88e88
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 2008-11-20
Route ORAL
Dosage form TABLET
Substance IBUPROFEN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 67296-0913-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 67296-0913-01. 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

LabelerRedPharm Drug, Inc.
Application holderDR REDDYS LABORATORIES INC
FDA applicationANDA075682 (ANDA)
Labeler code67296
First marketedNov 2008
Product typeHuman Prescription Drug
Portfolio26 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.

🩺 Clinical

📗 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 →
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.

💊 What it looks like

Color white
ShapeCapsule
Imprint6I
Size9 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 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 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 $4.00 / 30 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

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

🏛️
2008
On the market since
Nov 2008
📍
2026
Currently FDA-listed
18 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 Ibu — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Ibu. 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
$322.2K
Claims incl. refills
63.5K
Beneficiaries
50.9K
Spend / beneficiary
$6.33
Spend / claim
$5.07
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
67296-0913-01 You're viewing this 30 TABLET in 1 BOTTLE (67296-0913-1) 2008-11-20 Active
67296-0913-03 10 TABLET in 1 BOTTLE (67296-0913-3) 2008-11-20 Active
67296-0913-09 90 TABLET in 1 BOTTLE (67296-0913-9) 2008-11-20 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 67296-0913-01?
NDC 67296-0913-01 is a 30-count package — 30 tablet in 1 bottle.
What is the difference between NDC 67296-0913-01 and NDC 67296-0913-03?
Both are IBU 600 mg Tablet — the drug itself is identical. NDC 67296-0913-01 is the 30-count package, while NDC 67296-0913-03 is the 10 tablets package.
What NDC number is used to bill for this package of IBU 600 mg Tablet?
Bill NDC 67296-0913-01 — the 11-digit billing format is 67296091301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 67296-0913-1, 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: 67296-0913-01, written without dashes as 67296091301. 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 67296-0913-01, the first segment (67296) is the labeler code FDA assigned to RedPharm Drug, Inc.; the middle segment (0913) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 RedPharm Drug, Inc.. 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 2 other package presentations of this same product, including 10 tablets (67296-0913-03), 90 tablets (67296-0913-09). 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?
RedPharm Drug, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 111 words ▾

BOXED WARNING BOXED WARNING 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).

IBU 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 gastrointestinaladverse events including bleeding, ulceration, and perforationof the stomach or intestines, which can be fatal. These eventscan occur at any time during use and without warning symptoms.Elderly patients are at greater risk for serious gastrointestinalevents.

(See WARNINGS).

🎯 Indications and Usage 92 words ▾

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain.

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

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of IBU tabletsand other treatment options before deciding to use IBU tablets. Usethe lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). After observing the response to initial therapy with IBU tablets, thedose and frequency should be adjusted to suit an individual patient’sneeds.Do not exceed 3200 mg total daily dose.

If gastrointestinal complaintsoccur, administer IBU tablets with meals or milk. Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic disease: Suggested Dosage: 1200 mg-3200 mg daily (400 mg, 600 mg or800 mg tid or qid). Individual patients may show a better responseto 3200 mg daily, as compared with 2400 mg, although in well-controlledclinical trials patients on 3200 mg did not show a better meanresponse in terms of efficacy.

Therefore, when treating patients with3200 mg/day, the physician should observe sufficient increased clinicalbenefits to offset potential increased risk.The dose should be tailored to each patient, and may be loweredor raised depending on the severity of symptoms either at time of initiatingdrug therapy or as the patient responds or fails to respond.In general, patients with rheumatoid arthritis seem to require higherdoses of IBU tablets than do patients with osteoarthritis. The smallest dose of IBU tablets that yields acceptable controlshould be employed.

A linear blood level dose-response relationshipexists with single doses up to 800 mg (See CLINICAL PHARMACOLOGYfor 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 IBU tablets is sometimes seen in a few days to a week but most often isobserved by two weeks. After a satisfactory response has beenachieved, the patient’s dose should be reviewed and adjusted asrequired.

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

⛔ Contraindications 68 words ▾

CONTRAINDICATIONS IBU tablets are contraindicated in patients with known hypersensitivityto ibuprofen. IBU tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, ANAPHYLACTOID REACTIONS, and PRECAUTIONS, PREEXISTING ASTHMA).

IBU 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, increases the risk of serious gastrointestinal (GI) events (see WARNINGS). Status Post Coronary 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 to follow-up. Avoid the use of Ibuprofen in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Ibuprofen is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Hypertension NSAIDs including IBU tablets, can lead to onset of new hypertensionor worsening of preexisting hypertension, either of which maycontribute to the increased incidence of CV events. Patients takingthiazides or loop diuretics may have impaired response to these therapieswhen taking NSAIDs. NSAIDs, including IBU tablets, should beused with caution in patients with hypertension.

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

Additionally, fluid retention and edema have been observed in some pat…

🤒 Adverse Reactions 201 words ▾

ADVERSE REACTIONS The most frequent type of adverse reaction occurring withIbuprofen tablets is gastrointestinal. In controlled clinical trials thepercentage of patients reporting one or more gastrointestinal complaintsranged from 4% to 16%. In controlled studies when Ibuprofen tablets were compared toaspirin and indomethacin in equally effective doses, the overall incidenceof gastrointestinal complaints was about half that seen in eitherthe aspirin- or indomethacin-treated patients.

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

Still other reactions occurring less frequently than 1 in 100 werereported in controlled clinical trials and from marketing experience.These reactions have been divided into two categories: Column twoof the table lists reactions with therapy with Ibuprofen tablets wherethe probability of a causal relationship exists: for the reactions inColumn three, a causal relationship with Ibuprofen tablets has notbeen established. Reported side effects were higher at doses of 3200 mg/day thanat doses of 2400 mg or less per day in clinical trials of patients withrheumatoid arthritis.

The increases in incidence were slight and stillwithin the ranges reported in the table

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Approximately 11⁄2 hours after the reported ingestion of from 7 to10 Ibuprofen tablets (400 mg), a 19-month old child weighing 12 kgwas 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 fluidswere given; a greenish-yellow fluid was aspirated from the stomachwith no evidence to indicate the presence of ibuprofen.

Two hoursafter ingestion the child’s condition seemed stable; she still respondedonly to painful stimuli and continued to have periods of apnea lastingfrom 5 to 10 seconds. She was admitted to intensive care andsodium bicarbonate was administered as well as infusions of dextroseand normal saline. By four hours post-ingestion she could bearoused easily, sit by herself and respond to spoken commands.Blood level of ibuprofen was 102.9 μg/mL approximately 81⁄2 hoursafter accidental ingestion.

At 12 hours she appeared to be completelyrecovered. In two other reported cases where children (each weighingapproximately 10 kg) accidentally, acutely ingested approximately120 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 aperiod of a few hours complained of dizziness, and nystagmus wasnoted. After hospitalization, parenteral hydration and three days bedrest, he recovered with no reported sequelae.

In cases of acute overdosage, the stomach should be emptied byvomiting or lavage, though little drug will likely be recovered if morethan an hour has elapsed since ingestion. Because the drug is acidicand is excreted in the urine, it is theoretically beneficial to administeralkali and induce diuresis. In addition to supportive measures, the useof oral activated charcoal may help to reduce the absorption andreabsorption of Ibuprofen tablets.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY IBU tablets contain ibuprofen which possesses analgesic andantipyretic activities. Its mode of action, like that of other NSAIDs, isnot completely understood, but may be related to prostaglandin synthetaseinhibition. In clinical studies in patients with rheumatoid arthritis andosteoarthritis, Ibuprofen tablets have been shown to be comparableto aspirin in controlling pain and inflammation and to be associatedwith a statistically significant reduction in the milder gastrointestinalside effects (see ADVERSE REACTIONS).

Ibuprofen may be well toleratedin some patients who have had gastrointestinal side effectswith aspirin, but these patients when treated with IBU tablets shouldbe carefully followed for signs and symptoms of gastrointestinalulceration and bleeding. Although it is not definitely known whetheribuprofen causes less peptic ulceration than aspirin, in one studyinvolving 885 patients with rheumatoid arthritis treated for up to oneyear, there were no reports of gastric ulceration with ibuprofenwhereas frank ulceration was reported in 13 patients in the aspiringroup (statistically significant p<.001).

Gastroscopic studies at varying doses show an increased tendencytoward gastric irritation at higher doses. However, at comparabledoses, gastric irritation is approximately half that seen with aspirin.Studies using 51Cr-tagged red cells indicate that fecal blood lossassociated with Ibuprofen tablets in doses up to 2400 mg daily didnot exceed the normal range, and was significantly less than thatseen in aspirin-treated patients. In clinical studies in patients with rheumatoid arthritis, Ibuprofenhas been shown to be comparable to indomethacin in controlling thesigns and symptoms of disease activity and to be associated with astatistically 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 ofthe symptoms of primary dysmenorrhea. In patients with primary dysmenorrhea, Ibuprofen has been shown to reduce elevated levels of prostaglandin activity in the menstrualfluid and to reduce resting and active intrauterine pressure, as well asthe frequency of uterine contractions.

The probable mechanism ofaction is to inhibit prostaglandin synthesis rather than simply to provide analgesia. The ibuprofen in IBU 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 underthe 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 is 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 given in conjunction with anantacid containing both aluminum hydroxide and magnesium hydroxide. Ibuprofen is rapidly metabolized and eliminated in the urine.

The excretion of ibuprofen is virtually complete 24 hours after the last dose. The serum half-life is 1.8 to 2.0 hours. Studies have shown that following ingestion of the drug, 45% to79% of the dose was recovered in the urine within 24 hours as metabolite A (25%), (+)-2-[p-(2hydroxymethyl-propyl) phen…

📦 How Supplied / Storage and Handling 133 words ▾

HOW SUPPLIED IBU tablets are available in the following strengths, colors and sizes: 400 mg (white, oval, debossed 4I) Bottles of 90 NDC 55111-682-09 Bottles of 100 NDC 55111-682-01 Bottles of 500 NDC 55111-682-05 (PACKAGE NOT CHILD-RESISTANT) 600 mg (white, caplet, debossed 6I) Bottles of 30 NDC 55111-683-30 Bottles of 50 NDC 55111-683-50 Bottles of 90 NDC 55111-683-09 Bottles of 100 NDC 55111-683-01 Bottles of 500 NDC 55111-683-05 (PACKAGE NOT CHILD-RESISTANT) 800 mg (white, caplet, debossed 8I) Bottles of 30 NDC 55111-684-30 Bottles of 50 NDC 55111-684-50 Bottles of 60 NDC 55111-684-60 Bottles of 90 NDC 55111-684-09 Bottles of 100 NDC 55111-684-01 Bottles of 500 NDC 55111-684-05 (PACKAGE NOT CHILD-RESISTANT) Store at room temperature.

Avoid excessive heat 40°C (104°F). Manufactured by: Dr. Reddy’s Laboratories Louisiana, LLC Shreveport, LA 71106 USA Revised, July 2016

📋 Description 91 words ▾

DESCRIPTION IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith 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: [strucuture] IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.

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.