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Xeljanz tofacitinib 5 mg Tablet, Film Coated, 60-count — NDC 0069-1001-01 (Billing 00069-1001-01)

by Pfizer Laboratories Div Pfizer Inc · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Xeljanz tofacitinib 5 mg Tablet, Film Coated from Pfizer Laboratories Div Pfizer Inc, marketed since Nov 2012 and currently FDA-listed; retail pharmacies pay about $73.77 per tablet (NADAC). It is this product's only package size.

NDC 00069-1001-01
🏷️ FDA NDC (as labeled) 0069-1001-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0069-1001-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0069 labeler · 1001 product · 01 package
Package marketed since
Nov 9, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
60 EA per package
Barcode (UPC-A, from the NDC)
3 0069100101 1
Medicaid fills, this package
15,975 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0069-1001-01
Product NDC 0069-1001
11-digit billing NDC 00069100101
NCPDP billing unit EA — each (per item)
Application # NDA203214
SPL Set ID 23ff09f3-4af4-4232-a8b3-d84f8f16fb9c
Established class (EPC) Janus Kinase Inhibitor
Mechanism of action Janus Kinase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-11-09
Route ORAL
Dosage form TABLET, FILM COATED
Substance TOFACITINIB CITRATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 070233
GCN 33617
HICL code 039768
Ingredient (HICL) Tofacitinib Citrate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2Z
Therapeutic class — specific (HIC3) Janus Kinase (Jak) Inhibitors
AHFS code 90:24.12.92
AHFS class Janus Kinase Inhibitors, Miscellaneous
FDB label name XELJANZ 5 MG TABLET
FDB brand name Xeljanz
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 070233
  • GCN: 33617
  • HICL (First Databank): 039768
  • AHFS class code: 90:24.12.92
Why two NDCs? The FDA registers this code as 0069-1001-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00069-1001-01. 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.

Clinical

Label name XELJANZ 5 MG TABLET Ingredient Tofacitinib Citrate
📖 What it is MedlinePlus · NLM

Tofacitinib is used to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function), psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), and polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function). Tofacitinib is in a clas...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults, usually after a TNF blocker didn't work or wasn't tolerated. Xeljanz a...
  • You take it by mouth. Tablets and solution are usually taken twice a day, and extended-release tablets once a day. It can be taken with or without food. Follow your prescriber's di...
  • Colds, stuffy or sore nose and throat, diarrhea, and headache are most common. Some people with ulcerative colitis also get rash, shingles, or higher cholesterol. Call your doctor...
  • Get help right away for chest pain, stroke symptoms, sudden shortness of breath, or leg swelling and pain, which can signal a clot or heart problem. Also report new belly pain, sig...
📖 Read our full Tofacitinib guide →
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.

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 eaPer package
Retail pharmacies payNADAC · weekly $73.772 $4,426.30 / 60 tablets
Medicaid paysCMS SDUD · 12 mo $92.80 $5,568.19 / 60 tablets
Medicare drug plans payPart D · Q2 2026 $73.83 $4,430.02 / 60 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Jan 2026 Jun 2026 Sep 2026 $93.660 $73.573
▼ Down 12% over the last 8 months.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00069-1001-01 You're viewing this Main listing 60 TABLET, FILM COATED in 1 BOTTLE 2012-11-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tofacitinib 5 mg 33342-0541-09 Macleods 60 tablets $0.573 AB Availability likely save 99%
Tofacitinib 5 mg 51991-0329-06 Breckenridge 60 tablets $0.573 AB Availability likely save 99%
Tofacitinib 5 mg 59651-0459-60 Aurobindo 60 tablets $0.573 AB Availability likely save 99%
Tofacitinib 5 mg 70069-0841-01 Somerset 60 tablets $0.573 AB Availability likely save 99%
tofacitinib 5 mg 70710-1243-06 Zydus 60 tablets $0.573 AB Availability likely save 99%
Xeljanz 5 mgthis 00069-1001-01 Pfizer 60 tablets $73.772 AB Availability likely —
Tofacitinib 5 mg 42571-0268-05 Micro 500 tablets — AB FDA listed —
Tofacitinib 5 mg 60505-6263-05 Apotex 500 tablets — AB FDA listed —
Xeljanz 5 mg 63539-0012-02 U.S. 60 tablets — AB FDA listed —
tofacitinib 5 mg 70771-1821-06 Zydus 60 tablets — AB FDA listed —
Tofacitinib 5 mg 72205-0139-28 Novadoz 28 tablets — AB FDA listed —
Tofacitinib 5 mg 73190-0100-60 AvKARE 60 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2018
First FDA approval
May 2018
📍
2026
Currently FDA-listed
8 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 30, 2018 AB TE-rated RLD RS ⏳ ~1.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US RE41783 — drug substance
US RE41783 — drug substance
US RE41783*PED — drug product
US RE41783*PED — drug product
Exclusivity M-14
Exclusivity PED
2018 2020 2022 2024 2026 2028
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US RE41783 ↗ Drug substance — Dec 8, 2025
US RE41783 ↗ Drug substance — Dec 8, 2025
US RE41783*PED ↗ Drug product — Jun 8, 2026
US RE41783*PED ↗ Drug product — Jun 8, 2026
FDA exclusivity
CodeWhat it grantsExpires
M-14New indication / labeling change (3-year)Feb 21, 2028
PEDPediatric Exclusivity (+6 months)Aug 21, 2028
Common questions
Is there a generic version of XELJANZ 5 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for XELJANZ 5 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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.

🧪 Avoiding an ingredient? See Tofacitinib inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerPfizer Laboratories Div Pfizer Inc
Application holderPF PRISM CV
FDA applicationNDA203214 (NDA)
Labeler code00069
First marketedNov 2012
Product typeHuman Prescription Drug
Portfolio242 products on file

More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00069

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.

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.
📄 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 ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
16K
Units reimbursed last 4 qtrs
996.5K
Gross reimbursed last 4 qtrs
$92.47M
Avg / prescription
$5,788.71
Avg / unit
$92.8032
Latest quarter Q1 2026
3.6KRx
Medicaid pays / ea
$92.8032
gross reimbursed
vs
NADAC / ea
$73.7716
acquisition cost
=
Spread
+$19.0316
+26% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
45% FFS 55% MCO
Fee-for-service · 7,231 Rx Managed care · 8,744 Rx
State Medicaid map
Alaska: 1,770 units · 241 per 100k residents AK Maine: 3,900 units · 280 per 100k residents ME Washington: 22,200 units · 284 per 100k residents WA Idaho: 6,328 units · 322 per 100k residents ID Montana: 4,560 units · 403 per 100k residents MT North Dakota: 8,484 units · 1,084 per 100k residents ND Minnesota: 19,080 units · 333 per 100k residents MN Wisconsin: 74,736 units · 1,265 per 100k residents WI Michigan: 15,720 units · 157 per 100k residents MI New York: 69,300 units · 354 per 100k residents NY Vermont: 5,850 units · 904 per 100k residents VT New Hampshire: 1,860 units · 133 per 100k residents NH Oregon: 5,760 units · 136 per 100k residents OR Nevada: 660 units · 20.7 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 4,860 units · 152 per 100k residents IA Illinois: 32,640 units · 260 per 100k residents IL Indiana: 15,300 units · 223 per 100k residents IN Ohio: 56,220 units · 477 per 100k residents OH Pennsylvania: 52,080 units · 402 per 100k residents PA New Jersey: 13,140 units · 141 per 100k residents NJ Massachusetts: 28,513 units · 407 per 100k residents MA California: 68,757 units · 176 per 100k residents CA Utah: 3,840 units · 112 per 100k residents UT Colorado: 80,310 units · 1,366 per 100k residents CO Nebraska: 1,560 units · 78.9 per 100k residents NE Missouri: 33,060 units · 534 per 100k residents MO Kentucky: 15,180 units · 335 per 100k residents KY West Virginia: 41,010 units · 2,317 per 100k residents WV Virginia: 7,680 units · 88.1 per 100k residents VA Maryland: 6,720 units · 109 per 100k residents MD Connecticut: 19,500 units · 539 per 100k residents CT Rhode Island: 1,500 units · 137 per 100k residents RI Arizona: 85,934 units · 1,156 per 100k residents AZ New Mexico: 7,680 units · 363 per 100k residents NM Kansas: no data reported KS Arkansas: 3,840 units · 125 per 100k residents AR Tennessee: 9,197 units · 129 per 100k residents TN North Carolina: 13,830 units · 128 per 100k residents NC South Carolina: 2,580 units · 48.0 per 100k residents SC Delaware: 840 units · 81.5 per 100k residents DE Oklahoma: 11,790 units · 291 per 100k residents OK Louisiana: 38,320 units · 838 per 100k residents LA Mississippi: 9,600 units · 327 per 100k residents MS Alabama: 2,820 units · 55.2 per 100k residents AL Georgia: 13,162 units · 119 per 100k residents GA D.C.: no data reported DC Hawaii: 3,210 units · 224 per 100k residents HI Texas: 22,980 units · 75.3 per 100k residents TX Florida: 26,340 units · 116 per 100k residents FL
Units reimbursed · per 100k residents
20.72,317
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 2,317 /100k
2 Colorado 1,366 /100k
3 Wisconsin 1,265 /100k
4 Arizona 1,156 /100k
5 North Dakota 1,084 /100k
6 Vermont 904 /100k
7 Louisiana 838 /100k
8 Connecticut 539 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Xeljanz — 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 Xeljanz. 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
$56.43M
Claims incl. refills
12.3K
Beneficiaries
5.6K
Spend / beneficiary
$10,081.06
Spend / claim
$4,571.76
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.
← 00069-0980-38 · Pfizer 00069-1002-01 · Pfizer →
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.