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IBUPROFEN 600 mg Tablet, Film Coated, 100-count — NDC 68071-4243-01 package photo

IBUPROFEN 600 mg Tablet, Film Coated, 100-count

by NuCare Pharmaceuticals,Inc. · 100 TABLET, FILM COATED in 1 BOTTLE (68071-4243-1)
NDC 68071-4243-01
🏷️ FDA NDC (as labeled) 68071-4243-1 billing pads the package segment with a zero
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

⚠️
Other active recalls for Ibuprofen (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 2, 2026 — Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. (STRIDES PHARMA INC) · FDA recall D-0390-2026
Class III · Oct 29, 2024 — Failed Tablet/Capsule Specifications (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0047-2025
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0644-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0646-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0645-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 68071-4243-1
Product NDC 68071-4243
11-digit billing NDC 68071424301
RxCUI 197806
UNII WK2XYI10QM
UPC 0368071424317
Application # ANDA090796
SPL Set ID 6365b2d6-2337-70c0-e053-2a91aa0aa960
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 2015-12-30
Route ORAL
Dosage form TABLET, FILM COATED
Substance IBUPROFEN
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68071-4243-1 — 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 → 68071-4243-01. 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

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

📖 What it is MedlinePlus · NLM

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a clas...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It does a lot more than just kill pain. Ibuprofen is an anti-inflammatory drug, so it relieves pain, reduces swelling and inflammation, and brings down fever. Over-the-counter prod...
  • What's ibuprofen actually used for — is it just a painkiller?
  • Yes, it really does help. Ibuprofen can irritate the stomach lining, so taking it with food or a glass of milk significantly reduces the chance of nausea or stomach upset. You don'...
  • Should I take ibuprofen with food? Does it really matter?
📖 Read our full Ibuprofen guide →
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
Imprint122
Size18 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

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

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price 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 $13.34 / 100 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 mg 67296-0913-01 RedPharm 30 tablets — AB FDA listed —
Ibuprofen 600 mg 67296-2181-01 Redpharm 10 tablets — — FDA listed —
Ibuprofen 600 mg 68071-2947-01 NuCare 21 tablets — AB FDA listed —
Ibuprofen 600 mg 68071-2998-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 600 mg 68071-3679-01 NuCare 100 tablets — — FDA listed —
Ibuprofen 600 mg 68071-3778-02 NuCare 20 tablets — — FDA listed —
Ibuprofen 600 mg 68071-3849-04 NuCare 4 tablets — — FDA listed —
Ibuprofen 600 mg 68071-4009-01 NuCare 21 tablets — AB FDA listed —
Ibuprofen 600 mgthis 68071-4243-01 NuCare 100 tablets — AB FDA listed —
Ibuprofen 600 mg 68071-4459-06 NuCare 6 tablets — AB FDA listed —
Ibuprofen 600 mg 68071-4887-03 NuCare 30 tablets — AB FDA listed —
Ibuprofen 600 mg 68071-4968-03 NuCare 30 tablets — AB FDA listed —
Ibuprofen 600 mg 68071-5066-04 NuCare 4 tablets — AB FDA listed —
Ibuprofen 600 mg 68788-8354-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 600 mg 68788-8531-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 600 mg 68788-8754-01 Preferred 100 tablets — — FDA listed —
Ibuprofen 600 mg 68788-9111-01 Preferred 100 tablets — AB FDA listed —
Ibuprofen 600 mg 69367-0448-01 Westminster 100 tablets — AB FDA listed —
Ibuprofen 600 mg 70010-0067-88 Granules 15000 tablets — AB FDA listed —
Ibuprofen 600 mg 70518-0761-00 REMEDYREPACK 20 tablets — AB FDA listed —
Ibuprofen 600 mg 70518-1364-01 REMEDYREPACK 30 tablets — AB Discontinued —
Ibuprofen 600 mg 70518-2902-00 REMEDYREPACK 30 tablets — — Discontinued —
Ibuprofen 600 mg 70518-3313-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 600 mg 70518-4341-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ibuprofen 600 mg 71205-0522-06 Proficient 6 tablets — AB FDA listed —
Ibuprofen 600 mg 71335-1207-00 Bryant 21 tablets — AB Discontinued —
Ibuprofen 600 mg 71335-1218-00 Bryant 21 tablets — AB FDA listed —
Ibuprofen 600 mg 71335-1503-00 Bryant 21 tablets — AB FDA listed —
Ibuprofen 600 mg 71335-2683-00 Bryant 21 tablets — AB FDA listed —
Ibuprofen 600 mg 71335-3121-00 Bryant 21 tablets — — FDA listed —
Ibuprofen 600 mg 71610-0222-60 Aphena 90 tablets — AB FDA listed —
Ibu 600 mg 71610-0501-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 600 mg 71610-0532-60 Aphena 90 tablets — AB FDA listed —
Ibu 600 mg 71610-0547-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 600 mg 71610-0629-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 600 mg 71610-0891-53 Aphena 60 tablets — AB FDA listed —
Ibuprofen 600 mg 71610-0895-60 Aphena 90 tablets — AB FDA listed —
Ibuprofen 600 mg 71610-0902-53 Aphena 60 tablets — — FDA listed —
Ibuprofen 600 mg 71610-0968-53 Aphena 60 tablets — AB FDA listed —
Ibuprofen 600 mg 72189-0231-21 DIRECT 21 tablets — AB FDA listed —
Ibuprofen 600 mg 72189-0643-21 Direct_Rx 21 tablets — AB FDA listed —
Ibuprofen 600 mg 72603-0909-01 NorthStar 500 tablets — AB FDA listed —
Ibuprofen 600 mg 72789-0187-30 PD-Rx 30 tablets — AB FDA listed —
Ibuprofen 600 mg 72789-0212-06 PD-Rx 6 tablets — AB FDA listed —
Ibuprofen 600 mg 72789-0363-01 PD-Rx 100 tablets — AB FDA listed —
ibuprofen 600 mg 73086-0211-01 SKYA 100 tablets — AB FDA listed —
Ibuprofen 600 mg 75907-0330-91 Dr. 2000 tablets — — FDA listed —
Ibuprofen 600 mg 76420-0576-01 Asclemed 100 tablets — AB FDA listed —
Ibuprofen 600 mg 76420-0847-01 Asclemed 100 tablets — — FDA listed —
Ibuprofen 600 mg 80425-0132-01 Advanced 30 tablets — AB FDA listed —
Ibuprofen 600 mg 80425-0154-01 Advanced 30 tablets — AB FDA listed —
Ibuprofen 600 mg 80425-0424-01 Advanced 30 tablets — AB FDA listed —
Ibuprofen 600 mg 80425-0426-01 Advanced 30 tablets — AB FDA listed —
Ibuprofen 600 mg 80425-0553-01 Advanced 30 tablets — — FDA listed —
Ibuprofen 600 mg 83008-0066-30 Quality 30 tablets — AB FDA listed —
Ibuprofen 600 mg 83615-0001-03 Bryant 30 tablets — AB FDA listed —
Ibuprofen 600 mg 87441-0044-01 Unit 30 tablets — AB FDA listed —
Ibuprofen 600 mg 85766-0219-01 Sportpharm 100 tablets — AB FDA listed —
Ibuprofen 600 mg 85534-0012-00 HAWAII 30 tablets — AB FDA listed —
Ibuprofen 600 mg 68788-4140-01 Preferred 100 tablets — — FDA listed —
Ibuprofen 600 mg 70518-4741-00 REMEDYREPACK 1 tablet — AB FDA listed —
Ibuprofen 600 mg 67877-0738-01 Ascend 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
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
68071-4243-01 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE (68071-4243-1) 2018-01-22 Active

🧭 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 68071-4243-1, 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: 68071-4243-01, written without dashes as 68071424301. 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 68071-4243-01, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (4243) 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 NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
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 31 words ▾

HOW SUPPLIED 600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) . NDC 68071-4243-1 BOTTLES OF 100

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68071-4242-03 · NuCare 68071-4245-05 · 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.