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(from DailyMed)

Ibuprofen 200 mg Capsule, 6,000-count

by Patheon Softgels Inc. · 6000 CAPSULE in 1 BOX (10888-8118-1)
NDC 10888-8118-01
🏷️ FDA NDC (as labeled) 10888-8118-1 billing pads the package segment with a zero
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) 10888-8118-1
Product NDC 10888-8118
11-digit billing NDC 10888811801
SPL Set ID f1558716-c028-46b9-be9a-57219416783c
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-03-24
Dosage form CAPSULE
Substance IBUPROFEN
Why two NDCs? The FDA registers this code as 10888-8118-1 — 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 → 10888-8118-01. 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.

🏭 Manufacturer & labeler

LabelerPatheon Softgels Inc.
Labeler code10888
First marketedMar 2009
Product typeDrug For Further Processing
Portfolio124 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.

🧪 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.
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 200 mg 70000-0571-01 Cardinal 20 capsules $0.078 — Availability likely —
Ibuprofen minis 200 mg 70677-1113-01 Strategic 20 capsules $0.078 — Availability likely —
Ibuprofen 200 mg 70677-1114-01 Strategic 40 capsules $0.078 — Availability likely —
Ibuprofen 200 mg 83324-0206-48 Chain 48 capsules $0.078 — Availability likely —
Ibuprofen 200 mg 46122-0593-41 AMERISOURCE 80 capsules $0.078 — Availability likely —
Ibuprofen 200 mg 00536-1147-30 Rugby 80 capsules $0.078 — Availability likely —
Ibuprofen 200 mg 46122-0580-41 AMERISOURCE 80 capsules $0.079 — Discontinued —
Ibuprofen 200 mg 62011-0368-01 Strategic 40 capsules $0.082 — FDA listed —
Ibuprofen 200 mg 70677-0046-01 Strategic 40 capsules $0.082 — FDA listed —
Ibuprofen Minis 200 mg 62011-0399-01 Strategic 20 capsules $0.082 — FDA listed —
Ibuprofen 200 200 mg 00363-0222-22 WALGREEN 120 capsules — — FDA listed —
Ibuprofen 200 mg 36800-0440-29 Topco 180 capsules — — FDA listed —
Ibuprofen 200 mg 41520-0745-18 Care 180 capsules — — FDA listed —
Ibuprofen 200 mg 49035-0228-03 Wal-Mart 300 capsules — — FDA listed —
Ibuprofen 200 mg 51013-0103-15 PuraCap 20 capsules — — FDA listed —
Ibuprofen 200 mg 51013-0405-25 PuraCap 40 capsules — — FDA listed —
Ibuprofen 200 mg 51013-0410-26 PuraCap 80 capsules — — FDA listed —
Ibuprofen 200 mg 51013-0421-15 PuraCap 20 capsules — — FDA listed —
Ibuprofen 200 mg 51013-0422-39 PuraCap 120 capsules — — FDA listed —
Ibuprofen 200 mg 51013-0429-26 PURACAP 80 capsules — — FDA listed —
Ibuprofen 200 mg 53345-0014-01 Humanwell 10000 capsules — — FDA listed —
Ibuprofen 200 mg 53345-0039-02 Humanwell 40 capsules — — FDA listed —
Ibuprofen 200 mg 55910-0197-12 Dolgencorp, 120 capsules — — FDA listed —
Ibuprofen 200 mg 55910-0399-12 DOLGENCORP, 120 capsules — — FDA listed —
Ibuprofen 200 mg 55910-0741-12 Dolgencorp, 120 capsules — — FDA listed —
Ibuprofen 200 mg 58602-0843-12 Aurohealth 40 capsules — — FDA listed —
Ibuprofen 200 mg 58602-0879-38 Aurohealth 300 capsules — — FDA listed —
Ibuprofen 200 mg 58602-0902-12 Aurohealth 40 capsules — — FDA listed —
Ibuprofen 200 mg 63868-0428-40 CHAIN 40 capsules — — FDA listed —
Ibuprofen 200 mg 63981-0750-36 Costco 360 capsules — — FDA listed —
Ibuprofen 200 mg 68196-0981-41 Sam's 400 capsules — — FDA listed —
Ibuprofen 200 mg 69168-0368-07 Allegiant 10 capsules — — FDA listed —
Ibuprofen 200 mg 69452-0239-22 Bionpharma 120 capsules — — FDA listed —
Migraine Relief 200 mg 69452-0263-11 Bionpharma 20 capsules — — FDA listed —
Ibuprofen 200 mg 00363-0221-11 WALGREEN 20 capsules — — FDA listed —
Migraine Relief 200 mg 00363-0240-78 WALGREENS 80 capsules — — FDA listed —
Ibuprofen 200 mg 00363-0945-16 Walgreens 160 capsules — — FDA listed —
Ibuprofen 200 mg 11673-0992-31 TARGET 300 capsules — — FDA listed —
Ibuprofen 200 mg 11822-0589-02 Rite 20 capsules — — FDA listed —
Ibuprofen 200 mg 11822-4258-01 RITE 20 capsules — — FDA listed —
Ibuprofen 200 mg 21130-0032-12 Better 40 capsules — — FDA listed —
Ibuprofen 200 mg 25000-0062-01 MARKSANS 20 capsules — — FDA listed —
Ibuprofen 200 mg 25000-0133-01 MARKSANS 20 capsules — — FDA listed —
Ibuprofen 200 mg 30142-0053-26 KROGER 200 capsules — — FDA listed —
Ibuprofen minis 200 mg 30142-0743-32 The 160 capsules — — FDA listed —
Ibuprofen 200 mg 30142-0745-02 The 200 capsules — — FDA listed —
Ibuprofen 200 mg 36800-0570-11 TOP 20 capsules — — FDA listed —
Ibuprofen minis 200 mg 49035-0265-16 EQUATE 160 capsules — — FDA listed —
Ibuprofen 200 mg 49035-0381-11 Wal-Mart 20 capsules — — FDA listed —
Ibuprofen 200 mg 49483-0700-39 TIME 240 capsules — — FDA listed —
Dolex Flex 200 mg 55758-0310-20 Pharmadel 20 capsules — — Discontinued —
Ibuprofen 200 mg 55910-0830-12 Dolgencorp, 120 capsules — — FDA listed —
Ibuprofen 200 mg 55910-0845-20 Dolgencorp, 200 capsules — — FDA listed —
Ibuprofen minis 200 mg 55910-0953-20 Dolgencorp, 20 capsules — — FDA listed —
Ibuprofen Minis 200 mg 58602-0858-12 Aurohealth 40 capsules — — FDA listed —
Ibuprofen 200 mg 59726-0123-16 P 160 capsules — — FDA listed —
Ibuprofen 200 mg 63868-0427-20 CHAIN 20 capsules — — FDA listed —
Ibuprofen 200 mg 63868-0470-20 Chain 20 capsules — — FDA listed —
Ibuprofen 200 mg 63941-0680-11 VALU 20 capsules — — FDA listed —
Ibuprofen 200 mg 63941-0745-20 Best 20 capsules — — FDA listed —
Advil Liquigels 200 mg 67751-0148-02 Navajo 1 capsule — — FDA listed —
Ibuprofen 200 mg 69452-0212-90 Bionpharma 360 capsules — — FDA listed —
Ibuprofen 200 mg 69452-0305-81 Bionpharma 400 capsules — — FDA listed —
Ibuprofen minis 200 mg 72476-0843-16 Care 160 capsules — — FDA listed —
Advil 200 mg 00573-0169-02 Haleon 2 capsules — — FDA listed —
Ibuprofen 200 mg 83324-0207-80 Chain 80 capsules — — FDA listed —
Ibuprofen 200 mg 10888-8114-01 Patheon 10000 capsules — — FDA listed —
Ibuprofen 200 mgthis 10888-8118-01 Patheon 6000 capsules — — FDA listed —
Ibuprofen 200 mg 10888-8231-01 Patheon 15000 capsules — — FDA listed —
ibuprofen 200 mg 11014-0355-03 Catalent 4000 capsules — — FDA listed —
ibuprofen 200 mg 11014-0357-01 Catalent 10000 capsules — — FDA listed —
Ibuprofen 200 mg 49588-0005-01 CATALENT 15000 capsules — — FDA listed —
Ibuprofen 200 mg 59651-0627-39 Aurobindo 3000 capsules — — FDA listed —
Ibuprofen 200 mg 36800-0193-11 TOP 20 capsules — — FDA listed —
Ibuprofen 200 mg 37808-0699-20 H 20 capsules — — FDA listed —
Ibuprofen 200 mg 42681-0052-01 Whole 100 capsules — — FDA listed —
Ibuprofen 200 mg 59726-0745-10 P 10 capsules — — FDA listed —
Advil Liqui-Gels 200 mg 66715-9752-02 Lil 2 capsules — — FDA listed —
Ibuprofen 200 mg 68196-0745-40 Sam's 400 capsules — — FDA listed —
basic care ibuprofen 200 mg 72288-0131-06 Amazon.com 160 capsules — — FDA listed —
Ibuprofen 200 mg 10888-8133-01 Patheon 6000 capsules — — FDA listed —
Ibuprofen 200 mg 10888-8135-01 Patheon 10000 capsules — — FDA listed —
Ibuprofen 200 mg 10888-8224-01 Patheon 10000 capsules — — FDA listed —
Pain Relief 200 mg 21130-0220-78 Albertsons 80 capsules — — FDA listed —
Ibuprofen 200 mg 35916-0989-01 Softgel 1000 capsules — — FDA listed —
Ibuprofen 200 mg 55910-0046-02 Dolgencorp, 200 capsules — — FDA listed —
Ibuprofen minis 200 mg 59726-0843-10 P 10 capsules — — FDA listed —
Ibuprofen 200 mg 68210-0200-01 SPIRIT 10 capsules — — FDA listed —
Ibuprofen 200 mg 68391-0610-99 BJWC 480 capsules — — FDA listed —
pain relief 200 mg 69452-0260-11 Bionpharma 20 capsules — — FDA listed —
pain relief 200 mg 69452-0262-30 Bionpharma 500 capsules — — FDA listed —
Ibuprofen 200 mg 69842-0649-80 CVS 80 capsules — — FDA listed —
Ibuprofen 200 mg 59651-0890-39 Aurobindo 3000 capsules — — FDA listed —
Ibuprofen 200 mg 70968-0724-04 Sofgen 16000 capsules — — FDA listed —
Ibuprofen 200 mg 21130-0745-18 Safeway, 180 capsules — — FDA listed —
Ibuprofen 200 mg 49483-0610-44 TIME 40 capsules — — FDA listed —
Motrin IB Migraine 200 mg 50580-0120-20 Kenvue 20 capsules — — FDA listed —
Motrin IB 200 mg 50580-0409-12 Kenvue 120 capsules — — FDA listed —
Ibuprofen 200 mg 55319-0552-20 Family 20 capsules — — FDA listed —
Ibuprofen 200 mg 59556-0895-13 Strides 80 capsules — — FDA listed —
Advil Liqui-Gels 200 mg 66715-6552-02 Lil 2 capsules — — FDA listed —
dye-free pain relief 200 mg 69452-0513-81 Bionpharma 400 capsules — — FDA listed —
Ibuprofen 200 mg 72036-0185-01 Harris 20 capsules — — FDA listed —
Ibuprofen 200 mg 21130-0699-18 Safeway, 180 capsules — — FDA listed —
Ibuprofen 200 mg 41163-0185-01 United 20 capsules — — FDA listed —
Ibuprofen 200 mg 50844-0754-09 L.N.K. 20 capsules — — FDA listed —
Ibuprofen 200 mg 53943-0212-15 DISCOUNT 40 capsules — — FDA listed —
Ibuprofen Minis 200 mg 55319-0971-16 Family 160 capsules — — FDA listed —
Ibuprofen 200 mg 59556-0764-11 Strides 120 capsules — — FDA listed —
Ibuprofen 200 mg 61504-0185-06 AMERIFOODS 300 capsules — — FDA listed —
Ibuprofen Pain Reliever/Fever Reducer 200 mg 65162-0770-02 Amneal 20 capsules — — FDA listed —
Ibuprofen 200 mg 00363-1610-23 WALGREENS 20 capsules — — FDA listed —
Ibuprofen minis 200 mg 69842-0643-02 CVS 20 capsules — — FDA listed —
Ibuprofen 200 mg 10888-8185-01 Patheon 12000 capsules — — FDA listed —
Ibuprofen 200 mg 10888-8282-01 Patheon 12500 capsules — — FDA listed —
ibuprofen 200 mg 11014-0008-01 Catalent 10000 capsules — — FDA listed —
Ibuprofen 200 mg 49588-0001-01 Catalent 10000 capsules — — FDA listed —
Ibuprofen 200 mg 59651-0072-82 Aurobindo 800 capsules — — FDA listed —
Ibuprofen 200 mg 21130-0070-80 BETTER 80 capsules — — FDA listed —
Ibuprofen 200 mg 36800-0221-11 TOP 20 capsules — — FDA listed —
Ibuprofen 200 mg 37835-0588-16 Bi-Mart 160 capsules — — FDA listed —
Ibuprofen 200 mg 41226-0700-80 KROGER 80 capsules — — FDA listed —
Ibuprofen Pain Reliever/Fever Reducer 200 mg 65162-0356-02 Amneal 20 capsules — — FDA listed —
Ibuprofen 200 mg 70264-0043-01 R 2 capsules — — FDA listed —
Ibuprofen 200 mg 10888-8161-01 Patheon 15000 capsules — — FDA listed —
ibuprofen 200 mg 10888-8266-01 Patheon 15000 capsules — — FDA listed —
ibuprofen 200 mg 11014-0017-03 Catalent 5000 capsules — — FDA listed —
Ibuprofen 200 mg 11822-3307-01 Rite 40 capsules — — FDA listed —
Ibuprofen 200 mg 41250-0286-22 MEIJER 120 capsules — — FDA listed —
Ibuprofen 200 mg 41250-0293-15 MEIJER 40 capsules — — FDA listed —
Ibuprofen 200 mg 59726-0279-20 P 20 capsules — — FDA listed —
Ibuprofen minis 200 mg 63981-0192-05 Costco 500 capsules — — FDA listed —
Ibuprofen 200 mg 68016-0813-40 Chain 40 capsules — — FDA listed —
Ibuprofen minis 200 mg 69607-8438-00 WR 80 capsules — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2009
On the market since
Mar 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 (matched by generic name) — 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. CMS lists 3 products for this generic; we show the highest-spend one. 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
10888-8118-01 You're viewing this 6000 CAPSULE in 1 BOX (10888-8118-1) — Active

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Patheon Softgels Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
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 10888-8118-1, 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: 10888-8118-01, written without dashes as 10888811801. 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 10888-8118-01, the first segment (10888) is the labeler code FDA assigned to Patheon Softgels Inc.; the middle segment (8118) 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 Patheon Softgels Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Patheon Softgels 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.
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 FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10888-8117-01 · Patheon 10888-8119-01 · Patheon →
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.