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IBUPROFEN 800 mg Tablet, Film Coated, 12-count

by NuCare Pharmaceuticals,Inc. · 12 TABLET, FILM COATED in 1 BOTTLE (68071-3362-0)
NDC 68071-3362-00
🏷️ FDA NDC (as labeled) 68071-3362-0 billing pads the package segment with a zero
This package
Contains12-count Pack sizes8 compare ↓
Also comes in: 15 tablets 68071-3362-05 20 tablets 68071-3362-02 21 tablets 68071-3362-01 30 tablets 68071-3362-03 40 tablets 68071-3362-04 60 tablets 68071-3362-06 90 tablets 68071-3362-09
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Ibuprofen (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 2, 2026 — Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. (STRIDES PHARMA INC) · FDA recall D-0390-2026
Class III · Oct 29, 2024 — Failed Tablet/Capsule Specifications (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0047-2025
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0644-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0646-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0645-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Apr 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 68071-3362-0
Product NDC 68071-3362
11-digit billing NDC 68071336200
RxCUI 197807
UNII WK2XYI10QM
UPC 0368071336238
Application # ANDA090796
SPL Set ID 553c8cfa-cf0f-0b1f-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 Discontinued
FDA listing status Discontinued by firm (certified through Apr 2024)
Marketing start 2015-12-30
Route ORAL
Dosage form TABLET, FILM COATED
Substance IBUPROFEN
GPI-14 66100020000340
GPI class Ibuprofen
GCN Seq No 008350
GCN 35744
HICL code 003723
Ingredient (HICL) Ibuprofen
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2B
Therapeutic class — specific (HIC3) Nsaids, Cyclooxygenase Inhibitor Type Analgesics
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name IBUPROFEN 800 MG TABLET
FDB brand name Ibuprofen
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68071-3362-0 — 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 → 68071-3362-00. 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

LabelerNuCare Pharmaceuticals,Inc.
Application holderMARKSANS PHARMA LTD
FDA applicationANDA090796 (ANDA)
Labeler code68071
First marketedDec 2015
Product typeHuman Prescription Drug
Portfolio1,015 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

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 →
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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 15 tablets 20 tablets 21 tablets 30 tablets 40 tablets 60 tablets 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ibuprofen 800 mg 42543-0964-07 Strides 500 tablets $0.057 AB Discontinued —
Ibuprofen 800 mg 00904-5855-40 Major 500 tablets $0.057 AB Availability likely —
Ibuprofen 800 mg 49483-0604-01 TIME 100 tablets $0.057 AB Availability likely —
Ibuprofen 800 mg 55111-0684-01 Dr. 100 tablets $0.057 — Availability likely —
Ibuprofen 800 mg 59651-0362-01 Aurobindo 100 tablets $0.057 AB Availability likely —
Ibuprofen 800 mg 60687-0468-01 American 100 tablets $0.057 AB Availability likely —
Ibuprofen 800 mg 62135-0402-12 Chartwell 120 tablets $0.057 — Availability likely —
Ibuprofen 800 mg 64380-0807-06 Strides 100 tablets $0.057 AB Availability likely —
Ibuprofen 800 mg 67877-0321-01 Ascend 100 tablets $0.057 — Availability likely —
Ibuprofen 800 mg 68645-0563-54 Legacy 30 tablets $0.057 AB Availability likely —
Ibuprofen 800 mg 69367-0396-01 Westminster 100 tablets $0.057 — Availability likely —
Ibuprofen 800 mg 70512-0780-10 SOLA 100 tablets $0.057 AB Availability likely —
Ibuprofen 800 mg 76282-0714-10 EXELAN 100 tablets $0.057 AB Availability likely —
Ibuprofen 800 mg 71921-0182-01 Florida 100 tablets $0.066 AB FDA listed —
Ibuprofen 800 mg 69238-1103-05 Amneal 500 tablets $0.074 AB FDA listed —
Ibuprofen 800 mg 00615-8311-39 NCS 30 tablets — AB Discontinued —
Ibuprofen 800 mg 00904-7592-40 Major 500 tablets — AB FDA listed —
Ibuprofen 800 mg 11788-0010-00 AiPing 17000 tablets — — Discontinued —
Ibuprofen 800 mg 25000-0123-03 MARKSANS 30 tablets — AB FDA listed —
Ibuprofen 800 mg 43063-0914-30 PD-Rx 30 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-2548-00 A-S 10 tablets — AB Discontinued —
Ibuprofen 800 mg 50090-2549-00 A-S 4 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-2597-00 A-S 30 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-5444-04 A-S 28 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-5445-00 A-S 30 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-5446-00 A-S 10 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-6616-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-6645-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-6886-00 A-S 90 tablets — AB FDA listed —
Ibuprofen 800 mg 50090-7281-05 A-S 90 tablets — — FDA listed —
Ibuprofen 800 mg 50090-7282-00 A-S 90 tablets — — FDA listed —
Ibuprofen 800 mg 50090-7283-00 A-S 10 tablets — — FDA listed —
Ibuprofen 800 mg 50090-7320-00 A-S 30 tablets — — FDA listed —
Ibuprofen 800 mg 50090-7905-00 A-S 500 tablets — — FDA listed —
Ibuprofen 800 mg 51407-0841-01 Golden 100 tablets — AB FDA listed —
Ibuprofen 800 mg 51655-0275-20 Northwind 20 tablets — AB FDA listed —
Ibuprofen 800 mg 51655-0385-20 Northwind 20 tablets — AB Discontinued —
Ibuprofen 800 mg 53746-0137-01 Amneal 100 tablets — AB FDA listed —
Ibuprofen 800 mg 53746-0466-01 Amneal 100 tablets — AB FDA listed —
Ibuprofen 800 mg 54348-0825-00 PharmPak, 1 tablet — AB FDA listed —
Ibuprofen 800 mg 55154-1342-00 Cardinal 1 tablet — AB FDA listed —
Ibuprofen 800 mg 60760-0596-20 St. 20 tablets — AB FDA listed —
Ibuprofen 800 mg 60760-0604-00 St. 100 tablets — AB Discontinued —
Ibuprofen 800 mg 60760-0844-20 ST. 20 tablets — — FDA listed —
Ibuprofen 800 mg 60760-0929-20 St. 20 tablets — AB FDA listed —
Ibuprofen 800 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 mgthis 68071-3362-00 NuCare 12 tablets — AB Discontinued —
Ibuprofen 800 mg 68071-3415-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 800 mg 68071-3552-03 NuCare 3 tablets — AB FDA listed —
Ibuprofen 800 mg 68071-3696-08 NuCare 180 tablets — AB FDA listed —
Ibuprofen 800 mg 68071-3793-01 NuCare 21 tablets — — FDA listed —
Ibuprofen 800 mg 68071-3966-06 NuCare 6 tablets — — FDA listed —
Ibuprofen 800 mg 68071-4845-01 NuCare 21 tablets — AB FDA listed —
Ibuprofen 800 mg 68071-4949-03 NuCare 3 tablets — AB FDA listed —
Ibuprofen 800 mg 68071-5135-00 NuCare 100 tablets — AB FDA listed —
Ibuprofen 800 mg 68071-5140-03 NuCare 3 tablets — AB FDA listed —
Ibuprofen 800 mg 68788-8319-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 800 mg 68788-8710-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 800 mg 68788-8757-01 Preferred 100 tablets — — FDA listed —
Ibuprofen 800 mg 68788-9112-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 800 mg 69367-0449-01 Westminster 100 tablets — AB FDA listed —
Ibuprofen 800 mg 70010-0068-89 Granules 11400 tablets — AB FDA listed —
Ibuprofen 800 mg 70518-0176-02 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 800 mg 70518-1409-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 800 mg 70518-3178-00 REMEDYREPACK 15 tablets — AB FDA listed —
Ibuprofen 800 mg 70518-4010-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 800 mg 70518-4259-00 REMEDYREPACK 30 tablets — — FDA listed —
Ibuprofen 800 mg 71335-1073-00 Bryant 84 tablets — AB FDA listed —
Ibuprofen 800 mg 71335-1206-00 Bryant 84 tablets — AB FDA listed —
Ibuprofen 800 mg 71335-1396-00 Bryant 84 tablets — AB FDA listed —
Ibuprofen 800 mg 71335-2689-00 Bryant 84 tablets — AB FDA listed —
Ibuprofen 800 mg 71335-3108-01 Bryant 500 tablets — AB FDA listed —
Ibu 800 mg 71610-0550-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 800 mg 71610-0890-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 800 mg 71610-0892-53 Aphena 60 tablets — AB FDA listed —
Ibuprofen 800 mg 71610-0897-53 Aphena 60 tablets — AB FDA listed —
Ibuprofen 800 mg 71610-0898-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 800 mg 71610-0901-60 Aphena 90 tablets — — FDA listed —
Ibuprofen 800 mg 71610-0967-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 800 mg 72189-0266-15 DIRECT 15 tablets — AB FDA listed —
Ibuprofen 800 mg 72189-0556-20 Direct_Rx 20 tablets — AB FDA listed —
Ibuprofen 800 mg 72603-0910-01 NorthStar 100 tablets — AB FDA listed —
Ibuprofen 800 mg 72789-0186-30 PD-Rx 30 tablets — AB FDA listed —
Ibuprofen 800 mg 72789-0200-10 PD-Rx 10 tablets — AB FDA listed —
Ibuprofen 800 mg 72789-0218-30 PD-Rx 30 tablets — AB FDA listed —
Ibuprofen 800 mg 72789-0364-10 PD-Rx 10 tablets — AB FDA listed —
Ibuprofen 800 mg 72789-0382-30 PD-Rx 30 tablets — AB FDA listed —
Ibuprofen 800 mg 72789-0565-15 PD-Rx 15 tablets — — FDA listed —
ibuprofen 800 mg 73086-0212-01 SKYA 100 tablets — AB FDA listed —
Ibuprofen 800 mg 73614-0201-03 Brisk 30 tablets — — FDA listed —
Ibuprofen 800 mg 75907-0329-89 Dr. 1500 tablets — — FDA listed —
Ibuprofen 800 mg 76420-0415-01 Asclemed 100 tablets — AB FDA listed —
Ibuprofen 800 mg 76420-0577-01 Asclemed 100 tablets — AB FDA listed —
Ibuprofen 800 mg 76420-0848-01 Asclemed 100 tablets — — FDA listed —
Ibuprofen 800 mg 80425-0046-01 Advanced 90 tablets — AB FDA listed —
Ibuprofen 800 mg 80425-0047-01 Advanced 90 tablets — AB FDA listed —
Ibuprofen 800 mg 80425-0089-01 Advanced 30 tablets — AB FDA listed —
Ibuprofen 800 mg 80425-0243-04 Advanced 100 tablets — AB FDA listed —
Ibuprofen 800 mg 80425-0393-01 Advanced 30 tablets — AB FDA listed —
Ibuprofen 800 mg 80425-0537-01 Advanced 30 tablets — AB FDA listed —
Ibuprofen 800 mg 82804-0227-15 Proficient 15 tablets — — FDA listed —
Ibuprofen 800 mg 82804-0293-24 Proficient 24 tablets — AB FDA listed —
Ibuprofen 800 mg 82868-0069-30 Northwind 30 tablets — AB FDA listed —
Ibuprofen 800 mg 83008-0050-30 Quality 30 tablets — AB FDA listed —
Ibuprofen 800 mg 85509-1466-03 PHOENIX 30 tablets — AB FDA listed —
Ibuprofen 800 mg 85509-2396-03 PHOENIX 30 tablets — — FDA listed —
Ibuprofen 800 mg 87441-0045-01 Unit 30 tablets — AB FDA listed —
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 —
Ibuprofen 800 mg 67877-0739-01 Ascend 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
Dec 2015
📍
2026
Currently FDA-listed
11 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

283,500 reports
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
2019 2021 2023 2026 21,295 0
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 NDCDescription Marketing startStatus
68071-3362-00 You're viewing this 12 TABLET, FILM COATED in 1 BOTTLE (68071-3362-0) 2017-07-26 Discontinued by firm
68071-3362-01 21 TABLET, FILM COATED in 1 BOTTLE (68071-3362-1) 2017-07-26 Discontinued by firm
68071-3362-02 20 TABLET, FILM COATED in 1 BOTTLE (68071-3362-2) 2017-07-26 Discontinued by firm
68071-3362-03 30 TABLET, FILM COATED in 1 BOTTLE (68071-3362-3) 2017-07-26 Discontinued by firm
68071-3362-04 40 TABLET, FILM COATED in 1 BOTTLE (68071-3362-4) 2017-07-26 Discontinued by firm
68071-3362-05 15 TABLET, FILM COATED in 1 BOTTLE (68071-3362-5) 2017-07-26 Discontinued by firm
68071-3362-06 60 TABLET, FILM COATED in 1 BOTTLE (68071-3362-6) 2017-07-26 Discontinued by firm
68071-3362-09 90 TABLET, FILM COATED in 1 BOTTLE (68071-3362-9) 2017-07-26 Discontinued by firm

You're viewing the smallest of 8 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 68071-3362-00?
NDC 68071-3362-00 is a 12-count package — 12 tablet, film coated in 1 bottle.
What is the difference between NDC 68071-3362-00 and NDC 68071-3362-05?
Both are IBUPROFEN 800 mg Tablet, Film Coated — the drug itself is identical. NDC 68071-3362-00 is the 12-count package, while NDC 68071-3362-05 is the 15 tablets package.
What NDC number is used to bill for this package of IBUPROFEN 800 mg Tablet, Film Coated?
Bill NDC 68071-3362-00 — the 11-digit billing format is 68071336200. 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 No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 68071-3362-0, 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: 68071-3362-00, written without dashes as 68071336200. 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 68071-3362-00, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (3362) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 7 other package presentations of this same product, including 15 tablets (68071-3362-05), 20 tablets (68071-3362-02), 21 tablets (68071-3362-01). 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?
NuCare Pharmaceuticals,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.
📦 How Supplied / Storage and Handling
📦 How Supplied / Storage and Handling 42 words ▾

HOW SUPPLIED NDC 68071-3362-0 Bottles of 12 NDC 68071-3362-5 Bottles of 15 NDC 68071-3362-2 Bottles of 20 NDC 68071-3362-1 Bottles of 21 NDC 68071-3362-3 Bottles of 30 NDC 68071-3362-4 Bottles of 40 NDC 68071-3362-6 Bottles of 60 NDC 68071-3362-9 Bottles of 90

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68071-3361-03 · NuCare 68071-3366-03 · NuCare →
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.