HULIO adalimumab Kit
by Mylan Specialty L.P. · 2 TRAY in 1 KIT (49502-380-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-540-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-542-06) / 1 mL in 1 PACKET
NDC 49502-0380-02
🏷️ FDA NDC (as labeled)
49502-380-02
billing pads the product segment with a zero
Rx only
Brand
Discontinued
Non-controlled
⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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 Jun 2025. 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)
49502-380-02
Product NDC
49502-380
11-digit billing NDC
49502038002
NCPDP billing unit
EA — each (per item)
Application #
BLA761154
DEA schedule
Non-controlled
Marketing category
BLA
Marketing status
Discontinued
FDA listing status
Discontinued by firm (certified through Jun 2025)
Dosage form
KIT
GCN Seq No
081262
GCN
48317
HICL code
046685
Ingredient (HICL)
Adalimumab-Fkjp
HIC1 code
S
Therapeutic class — broad (HIC1)
Locomotor System
HIC2 code
S2
Therapeutic class — intermediate (HIC2)
Drugs Acting Principally On Joints
HIC3 code
S2J
Therapeutic class — specific (HIC3)
Anti-Inflammatory Tumor Necrosis Factor Inhibitor
AHFS code
90:24.16.92
AHFS class
Tumor Necrosis Factor Inhibitors, Misc
FDB label name
HULIO(CF) PEN 40 MG/0.8 ML
FDB brand name
Hulio(Cf) Pen
Legend status
F — Federal legend — prescription drug or device
Biologic (Purple Book)
351(k) Interchangeable · interchangeable biosimilar
Reference product
adalimumab
Why two NDCs?
The FDA registers this code as 49502-380-02 — a 5-3-2 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 product segment → 49502-0380-02. 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
LabelerMylan Specialty L.P.
FDA applicationBLA761154 (BLA)
Labeler code49502
Product typeHuman Prescription Drug
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 HULIO(CF) PEN 40 MG/0.8 ML Ingredient Adalimumab-Fkjp
📖 What it is MedlinePlus · NLM
Adalimumab injection is to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including the following: rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in adults juvenile idiopathic arthritis (JIA; a condition that affects children in which the body attacks its own joints, causing pain, swelling, loss of function, and delays in growth and development) Crohn's disease (a condition in which the body attacks...
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Adalimumab is approved for quite a few inflammatory conditions — rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psor...
- What conditions is adalimumab actually approved to treat?
- You'll use either an autoinjector pen or a prefilled syringe, depending on what your doctor prescribes. Before injecting, take it out of the refrigerator and let it sit for 15 to 3...
- How do I give myself this injection at home?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Adalimumab — tap one for details:
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.
💬 Questions about adalimumab?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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.
💲 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 system | Per each | Per 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. | |
| Medicare Part B allowsASP · Q5140 | No ASP payment limit on file for Q5140 this quarter. | |
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.
🧾 Billing & reimbursement
FDA NDC (as labeled)49502-380-02
11-digit billing NDC49502-0380-02
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeQ5140
DescriptorINJECTION, ADALIMUMAB-FKJP, BIOSIMILAR, 1 MG
Billing units / pkg40 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Humira 00074-0616-02 | AbbVie | 2 kits | $3,366.120 | — | Availability likely | — |
| Humira 00074-0243-02 | AbbVie | 2 kits | $3,368.310 | — | Availability likely | — |
| Humira 00074-3799-02 | AbbVie | 2 kits | $3,371.420 | — | Availability likely | — |
| Humira 00074-1539-03 | AbbVie | 3 kits | $4,441.470 | — | FDA listed | — |
| Hulio 83257-0019-32 | Biocon | 1 kit | — | — | FDA listed | — |
| Adalimumab 83257-0022-32 | Biocon | 1 kit | — | — | FDA listed | — |
| Humira 00074-0817-02 | AbbVie | 2 kits | — | — | FDA listed | — |
| Humira 83457-0124-02 | Cordavis | 2 kits | — | — | FDA listed | — |
| Humira 00074-0124-01 | AbbVie | 1 kit | — | — | FDA listed | — |
| Humira 00074-2540-01 | AbbVie | 1 kit | — | — | FDA listed | — |
| Humira 50090-4487-00 | A-S | 2 kits | — | — | FDA listed | — |
| Humira 83457-0243-02 | Cordavis | 2 kits | — | — | FDA listed | — |
| Humira 83457-0817-02 | Cordavis | 2 kits | — | — | FDA listed | — |
| Humira 00074-4339-01 | AbbVie | 1 kit | — | — | Discontinued | — |
| Humira 00074-0554-01 | AbbVie | 1 kit | — | — | FDA listed | — |
| Humira 83457-0554-02 | Cordavis | 2 kits | — | — | FDA listed | — |
| Humira 83457-0616-02 | Cordavis | 2 kits | — | — | FDA listed | — |
| Huliothis 49502-0380-02 | Mylan | 1 kit | — | — | Discontinued | — |
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status
🏛️
2020
First FDA approval
Jul 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
2026
Biosimilars listed
10 FDA-licensed
🧬FDA-licensed biosimilars listed
2 biosimilars and 8 interchangeables are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)
🛡️ Latest patent/protection date listed: Biosimilars are already FDA-licensed for this product — the last listed patent runs to Nov 2034.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
FDA Purple Book — biosimilars & interchangeables
ⓘ
Reference product
Interchangeable 8
Biosimilars 2
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
US 11,083,792 — biologic patent
US 11,191,834 — biologic patent
US 11,167,030 — biologic patent
US 8,916,153 — biologic patent
US 9,090,689 — biologic patent
US 9,090,688 — biologic patent
US 9,085,620 — biologic patent
US 9,085,619 — biologic patent
US 9,085,618 — biologic patent
US 9,067,992 — biologic patent
US 9,062,106 — biologic patent
US 9,061,005 — biologic patent
US 8,999,337 — biologic patent
US 8,992,926 — biologic patent
US 8,986,693 — biologic patent
US 8,974,790 — biologic patent
US 8,961,974 — biologic patent
US 8,961,973 — biologic patent
US 8,926,975 — biologic patent
US 9,957,318 — biologic patent
US 8,911,964 — biologic patent
US 8,911,737 — biologic patent
US 8,906,646 — biologic patent
US 8,906,373 — biologic patent
US 8,906,372 — biologic patent
US 8,895,009 — biologic patent
US 8,889,136 — biologic patent
US 8,883,156 — biologic patent
US 8,808,700 — biologic patent
US 8,715,664 — biologic patent
US 8,708,968 — biologic patent
US 8,663,945 — biologic patent
US 8,420,081 — biologic patent
US 8,231,876 — biologic patent
US 6,805,686 — biologic patent
US 9,096,666 — biologic patent
US 9,090,867 — biologic patent
US 9,913,902 — biologic patent
US 9,708,400 — biologic patent
US 9,683,033 — biologic patent
US 9,669,093 — biologic patent
US 9,624,295 — biologic patent
US 9,550,826 — biologic patent
US 9,546,212 — biologic patent
US 9,522,953 — biologic patent
US 9,512,216 — biologic patent
US 9,505,834 — biologic patent
US 9,499,616 — biologic patent
US 9,499,614 — biologic patent
US 9,359,434 — biologic patent
US 9,346,879 — biologic patent
US 9,334,319 — biologic patent
US 9,339,610 — biologic patent
US 9,102,723 — biologic patent
US 9,150,645 — biologic patent
US 9,181,337 — biologic patent
US 9,181,572 — biologic patent
US 9,187,559 — biologic patent
US 9,234,032 — biologic patent
US 9,273,132 — biologic patent
US 9,284,370 — biologic patent
US 9,284,371 — biologic patent
US 9,290,568 — biologic patent
US 9,315,574 — biologic patent
US 9,328,165 — biologic patent
US 9,266,949 — biologic patent
Exclusivity RefProduct
2020
2022
2024
2026
2028
2030
2032
2034
Biologic patent
Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
Listed patents (66)
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11,083,792 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 11,191,834 ↗ | Biologic patent | — | Nov 28, 2028 |
| US 11,167,030 ↗ | Biologic patent | — | Nov 28, 2028 |
| US 8,916,153 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 9,090,689 ↗ | Biologic patent | — | Jul 18, 2023 |
| US 9,090,688 ↗ | Biologic patent | — | Apr 26, 2032 |
| US 9,085,620 ↗ | Biologic patent | — | Jul 18, 2023 |
| US 9,085,619 ↗ | Biologic patent | — | Nov 28, 2028 |
| US 9,085,618 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,067,992 ↗ | Biologic patent | — | Jul 18, 2023 |
| US 9,062,106 ↗ | Biologic patent | — | Apr 26, 2032 |
| US 9,061,005 ↗ | Biologic patent | — | Apr 11, 2025 |
| US 8,999,337 ↗ | Biologic patent | — | Feb 6, 2031 |
| US 8,992,926 ↗ | Biologic patent | — | Jun 5, 2022 |
| US 8,986,693 ↗ | Biologic patent | — | Apr 11, 2025 |
| US 8,974,790 ↗ | Biologic patent | — | Jun 5, 2022 |
| US 8,961,974 ↗ | Biologic patent | — | Apr 11, 2025 |
| US 8,961,973 ↗ | Biologic patent | — | Apr 11, 2025 |
| US 8,926,975 ↗ | Biologic patent | — | Jun 8, 2027 |
| US 9,957,318 ↗ | Biologic patent | — | Apr 26, 2032 |
| US 8,911,964 ↗ | Biologic patent | — | Sep 13, 2027 |
| US 8,911,737 ↗ | Biologic patent | — | Jun 5, 2022 |
| US 8,906,646 ↗ | Biologic patent | — | Sep 13, 2027 |
| US 8,906,373 ↗ | Biologic patent | — | Jul 18, 2023 |
| US 8,906,372 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 8,895,009 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 8,889,136 ↗ | Biologic patent | — | Oct 9, 2027 |
| US 8,883,156 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 8,808,700 ↗ | Biologic patent | — | May 16, 2026 |
| US 8,715,664 ↗ | Biologic patent | — | Jul 24, 2027 |
| US 8,708,968 ↗ | Biologic patent | — | Jan 24, 2032 |
| US 8,663,945 ↗ | Biologic patent | — | Sep 13, 2027 |
| US 8,420,081 ↗ | Biologic patent | — | Jan 13, 2030 |
| US 8,231,876 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 6,805,686 ↗ | Biologic patent | — | May 6, 2023 |
| US 9,096,666 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 9,090,867 ↗ | Biologic patent | — | Sep 13, 2027 |
| US 9,913,902 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 9,708,400 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,683,033 ↗ | Biologic patent | — | Apr 26, 2032 |
| US 9,669,093 ↗ | Biologic patent | — | Jun 10, 2028 |
| US 9,624,295 ↗ | Biologic patent | — | Mar 31, 2031 |
| US 9,550,826 ↗ | Biologic patent | — | Nov 14, 2034 |
| US 9,546,212 ↗ | Biologic patent | — | Jun 5, 2022 |
| US 9,522,953 ↗ | Biologic patent | — | Apr 26, 2032 |
| US 9,512,216 ↗ | Biologic patent | — | Apr 11, 2025 |
| US 9,505,834 ↗ | Biologic patent | — | Apr 26, 2032 |
| US 9,499,616 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,499,614 ↗ | Biologic patent | — | Mar 14, 2034 |
| US 9,359,434 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,346,879 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,334,319 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,339,610 ↗ | Biologic patent | — | Jan 24, 2032 |
| US 9,102,723 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 9,150,645 ↗ | Biologic patent | — | May 13, 2033 |
| US 9,181,337 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,181,572 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,187,559 ↗ | Biologic patent | — | Apr 11, 2025 |
| US 9,234,032 ↗ | Biologic patent | — | Sep 13, 2027 |
| US 9,273,132 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 9,284,370 ↗ | Biologic patent | — | Jun 10, 2028 |
| US 9,284,371 ↗ | Biologic patent | — | Sep 13, 2027 |
| US 9,290,568 ↗ | Biologic patent | — | Mar 14, 2033 |
| US 9,315,574 ↗ | Biologic patent | — | Apr 21, 2033 |
| US 9,328,165 ↗ | Biologic patent | — | Apr 4, 2027 |
| US 9,266,949 ↗ | Biologic patent | — | May 13, 2033 |
FDA exclusivity
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Jul 6, 2032 |
Common questions
Is there a biosimilar for HULIO(CF) PEN 40 MG/0.8 ML?
Yes — at least one FDA-licensed biosimilar is listed for this biologic. See the Purple Book family above for the available products.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, 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 Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Humira(Cf) Pen (matched by generic name) — 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 Humira(Cf) Pen. CMS lists 6 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
$714.53M
Claims incl. refills
81.4K
Beneficiaries
38K
Spend / beneficiary
$18,817.67
Spend / claim
$8,777.42
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 HULIO (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 41%
Female · 59%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 49502-0380-02 You're viewing this | 2 TRAY in 1 KIT (49502-380-02) / 1 KIT in 1 TRAY * 2 TRAY in 1 KIT (49502-540-06) / 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE * 2 PACKET in 1 KIT (49502-542-06) / 1 mL in 1 PACKET | 2023-07-01 | Discontinued by firm |
🧭 About this NDC listing & data coverage
Finished prescription product
Kit / multi-component package
No longer marketed (per FDA listing data)
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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) | — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA. |
| 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 | ✓ Available |
| 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.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
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 49502-380-02, 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: 49502-0380-02, written without dashes as 49502038002. 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 49502-0380-02, the first segment (49502) is the labeler code FDA assigned to Mylan Specialty L.P.; the middle segment (0380) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Mylan Specialty L.P. 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code Q5140 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
📄 FDA label ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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.