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Tymlos abaloparatide 3.12 mg/1.56mL Injection, Solution, 1 cartridge — NDC 70539-0001-98 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tymlos abaloparatide 3.12 mg/1.56mL Injection, Solution, 1 cartridge — NDC 70539-001-98 (Billing 70539-0001-98)

by Radius Health, Inc. · 1 CARTRIDGE in 1 BOX, UNIT-DOSE / 1.56 mL in 1 CARTRIDGE

This is a package of 1 cartridge of Tymlos abaloparatide 3.12 mg/1.56mL Injection, Solution from Radius Health, Inc., marketed since May 2017 and currently FDA-listed.

NDC 70539-0001-98
🏷️ FDA NDC (as labeled) 70539-001-98 billing pads the product segment with a zero
This package
Contains1 cartridge Pack sizes2 compare ↓
Also priced by: Part D plans $1,871.16/unit — full pricing hub ↓
Product page 70539-0001-02 Also comes in: 1.56 mL 70539-001-02
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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 70539-001-98 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70539 labeler · 001 product · 98 package
Package marketed since
May 1, 2017
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7053900198 5
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70539-001-98
Product NDC 70539-001
11-digit billing NDC 70539000198
RxCUI 1921075, 1921081
UNII AVK0I6HY2U
Application # NDA208743
SPL Set ID 712143d9-e21e-4013-bb3b-3426a21060a8
Established class (EPC) Parathyroid Hormone-Related Peptide Analog
Chemical class Parathyroid Hormone-Related Protein
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-05-01
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance ABALOPARATIDE

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

GCN Seq No 077351
GCN 43334
HICL code 044231
Ingredient (HICL) Abaloparatide
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P4
Therapeutic class — intermediate (HIC2) Parathyroid/Bone Resorption Drugs
HIC3 code P4F
Therapeutic class — specific (HIC3) Bone Formation Stimulating Agts - Pth Rel Peptides
AHFS code 68:24.08.00
AHFS class Parathyroid Agents
FDB label name TYMLOS 80 MCG DOSE PEN INJECTR
FDB brand name Tymlos
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077351
  • GCN: 43334
  • HICL (First Databank): 044231
  • AHFS class code: 68:24.08.00
  • RxCUI (RxNorm): 1921075
Why two NDCs? The FDA registers this code as 70539-001-98 — 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 → 70539-0001-98. 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 Parathyroid Hormone-Related Peptide Analog class.

Pharmacologic class Parathyroid Hormone-Related Peptide Analog
Drug family (ATC) Parathyroid hormones and analogues
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.

Clinical

Label name TYMLOS 80 MCG DOSE PEN INJECTR Ingredient Abaloparatide
📗 Our plain-language guide HelloPharmacist
  • Tymlos works differently from most osteoporosis medications. Instead of just slowing bone loss, it actually stimulates your bone-building cells to form new bone — making your bones...
  • What exactly is Tymlos supposed to do for my bones?
  • You inject Tymlos just under the skin in the belly area around your navel, once a day. Try to do it at roughly the same time each day, but it doesn't have to be tied to meals. Rota...
  • How do I take it, and does it have to be at a specific time of day?
📖 Read our full Abaloparatide Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 mLPer 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 $1,871.16 $2,919.01 / 1.56 ml
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 Per unit Per pack Marketing startMarketing endStatus
70539-0001-02 70539-001-02 Main listing 1 CARTRIDGE in 1 BOX, UNIT-DOSE / 1.56 mL in 1 CARTRIDGE $1,646.36 / mL $2,568.32 2017-05-01 — Active
70539-0001-98 You're viewing this 1 CARTRIDGE in 1 BOX, UNIT-DOSE / 1.56 mL in 1 CARTRIDGE Sample — — 2017-05-01 — Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 1 cartridge — 1 cartridge in 1 box, unit-dose / 1.56 ml in 1 cartridge.
How does this package differ from NDC 70539-0001-02?
Both are Tymlos abaloparatide 3.12 mg/1.56mL Injection, Solution — the drug itself is identical. This page's package is the 1 cartridge one, while NDC 70539-0001-02 is the 1 cartridge package.
What NDC number is used to bill for this package of Tymlos abaloparatide 3.12 mg/1.56mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tymlos 3.12 mg/1.56mLthis 70539-0001-98 Radius 1 cartridge — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2017
First FDA approval
Apr 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2040
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2040. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 28, 2017 RLD RS ⏳ ~13.3 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.

When could a generic Tymlos arrive?

Our estimate: April 2038 about 11.5 years away

How sure: Likely. Firm enough to plan around, but a court ruling or a new deal could still move it.

Why then: A patent that protects the brand runs out. After that, approved generics can be sold.

That is before the January 2040 date above, which is common: a court ruling or a deal with the brand’s maker often lets a generic in before the last patent runs out.

See the full forecast for generic Tymlos →
Patents & exclusivity — FDA Orange Book
US 11680942 — method of use (U-3322)
US 8748382 — method of use (U-3543)
US 8748382 — method of use (U-2009)
US 11782041 — method of use (U-2009)
US 11782041 — method of use (U-3543)
US 7803770 — method of use (U-2009)
US RE49444 — method of use (U-2009)
US RE49444 — method of use (U-3543)
US 11255842 — method of use (U-3322)
US 8148333 — drug product
US 11977067 — drug product
US 10996208 — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039
Today
LOE
Expected generic
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 (12)
PatentTypeUse codeExpires
US 11680942 ↗ Method of use U-3322 Jan 10, 2040
US 8748382 ↗ Method of use U-3543 Oct 3, 2027
US 8748382 ↗ Method of use U-2009 Oct 3, 2027
US 11782041 ↗ Method of use U-2009 Apr 30, 2038
US 11782041 ↗ Method of use U-3543 Apr 30, 2038
US 7803770 ↗ Method of use U-2009 Apr 28, 2031
US RE49444 ↗ Method of use U-2009 Apr 28, 2031
US RE49444 ↗ Method of use U-3543 Apr 28, 2031
US 11255842 ↗ Method of use U-3322 Jan 10, 2040
US 8148333 ↗ Drug product — Nov 8, 2027
US 11977067 ↗ Drug product — Apr 30, 2038
US 10996208 ↗ Drug product — Apr 30, 2038
Common questions
Is there a generic version of TYMLOS 80 MCG DOSE PEN INJECTR?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TYMLOS 80 MCG DOSE PEN INJECTR. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2040 — an estimate, not a guaranteed launch date. We expect the first generic Tymlos in April 2038, about 11.5 years away. See the forecast.
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 Abaloparatide Injection 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.

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

  • 1.2 mg / 1.56 mL UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 7.8 mg / 1.56 mL UNII 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • 7.92 mg / 1.56 mL UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 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.

Manufacturer & labeler

LabelerRadius Health, Inc.
Application holderRADIUS HEALTH INC
FDA applicationNDA208743 (NDA)
Labeler code70539
First marketedMay 2017
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Radius Health, Inc. labeler code 70539

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 200 words ▾

1 INDICATIONS AND USAGE TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1.1 ) Treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1.2 )

1.1Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.

1.2Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture TYMLOS is indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage is 80 mcg subcutaneously once daily; patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. ( 2.1 ) Administer as a subcutaneous injection into periumbilical region of abdomen. ( 2.2 ) Administer initially where the patient can sit or lie down in case symptoms of orthostatic hypotension occur. ( 2.2 , 5.3 )

2.1Recommended Dosage The recommended dosage of TYMLOS is 80 mcg administered subcutaneously once daily. Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

2.2Administration Instructions Administer TYMLOS as a subcutaneous injection into the periumbilical region of the abdomen. Rotate the site of the injection every day and administer at approximately the same time every day. Do not administer intravenously or intramuscularly.

Administer the first several doses where the patient can sit or lie down if necessary, in case symptoms of orthostatic hypotension occur [see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.1 )] . Visually inspect TYMLOS for particulate matter and discoloration prior to administration. TYMLOS is a clear and colorless solution.

Do not use if solid particles appear or if the solution is cloudy or colored. Provide appropriate training and instruction to patients and caregivers on the proper use of the TYMLOS pen.

2.3Treatment Duration The safety and efficacy of TYMLOS have not been evaluated beyond 2 years of treatment. Use of the drug for more than 2 years during a patient's lifetime is not recommended.

💊 Dosage Forms and Strengths 73 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 3120 mcg/1.56 mL (2000 mcg/mL) of abaloparatide in clear, colorless solution in a single-patient-use prefilled pen. The prefilled pen delivers 30 doses of TYMLOS, each containing 80 mcg of abaloparatide in 40 mcL. Injection: 3120 mcg/1.56 ml (2000 mcg/ml) of abaloparatide in clear, colorless solution in a single-patient-use prefilled pen.

The prefilled pen delivers 30 daily doses of 80 mcg abaloparatide in 40 mcl. ( 3 )

⛔ Contraindications 58 words ▾

4 CONTRAINDICATIONS TYMLOS is contraindicated in patients with a history of severe hypersensitivity to abaloparatide or any of the inactive ingredients of TYMLOS. Reactions have included anaphylaxis, angioedema, dyspnea, and urticaria [see Warnings and Precautions (5.1) , Adverse Reactions ( 6.2 )] . Severe hypersensitivity to abaloparatide or any of the inactive ingredients of TYMLOS. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Anaphylaxis, angioedema, and urticaria have been reported in patients treated with parathyroid hormone analogs, including TYMLOS. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with TYMLOS, initiate supportive care, and monitor until signs or symptoms resolve. Discontinue TYMLOS permanently in patients with a severe hypersensitivity reaction to TYMLOS.

( 5.1 ) Osteosarcoma: Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget's disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. ( 5.2 ) Orthostatic Hypotension: Instruct patients to sit or lie down if symptoms develop after dose administration. ( 5.3 ) Hypercalcemia: Avoid use in patients with pre-existing hypercalcemia and those known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism.

( 5.4 ) Hypercalciuria and Urolithiasis: Monitor urine calcium if pre-existing hypercalciuria or active urolithiasis are suspected. ( 5.5 )

5.1Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria have been reported in patients treated with parathyroid hormone (PTH) analogs, including TYMLOS [see Adverse Reactions (6.2) ] . If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with TYMLOS, initiate appropriate supportive care, and monitor until signs and symptoms resolve. Discontinue TYMLOS permanently in patients with a severe hypersensitivity reaction to TYMLOS .

TYMLOS is contraindicated in patients with a history of severe hypersensitivity to abaloparatide or any of the inactive ingredients of TYMLOS [ see Contraindications (4) ].

5.2Risk of Osteosarcoma Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats after subcutaneous administration at exposures 4 to 28 times the human exposure at the clinical dose of 80 mcg [see Nonclinical Toxicology ( 13.1 )] . It is unknown whether TYMLOS will cause osteosarcoma in humans. Osteosarcoma has been reported in patients treated with a PTH-analog in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans.

There are limited data assessing the risk of osteosarcoma beyond 2 years of TYMLOS and/or use of a PTH-analog [see Dosage and Administration ( 2.3 ) and Nonclinical Toxicology ( 13.1 )] . Avoid TYMLOS use in patients with (these patients are at increased baseline risk of osteosarcoma): Open epiphyses (pediatric and young adult patients) (TYMLOS is not approved in pediatric patients) [see Use in Specific Populations ( 8.4 )] . Metabolic bone diseases other than osteoporosis, including Paget's disease of the bone.

Bone metastases or a history of skeletal malignancies. Prior external beam or implant radiation therapy involving the skeleton. Hereditary disorders predisposing to osteosarcoma.

5.3Orthostatic Hypotension Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection. Associated symptoms may include dizziness, palpitations, tachycardia, or nausea, and may resolve by having the patient lie down. For the first several doses, TYMLOS should be administered where the patient can sit or lie down if necessary [see Adverse Reactions ( 6.1 )] .

5.4Hypercalcemia TYMLOS may cause hypercalcemia. TYMLOS is not recommended in patients with pre-existing hypercalcemia or in patients who have an underlying hypercalcemic disorder, such as primary hyperparathyroidism, because of the possibility of exacerbating hypercalcemia [see Adverse Reactions ( 6.1 )] .

5.5Hypercalciuria and Urolithiasis TYMLOS may cause hypercalciuria. It is unknown whether TYMLOS may exacerbate urolithiasis in patients with active… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Risk of Osteosarcoma [see Warnings and Precautions (5.2) ] Orthostatic Hypotension [see Warnings and Precautions ( 5.3 )] Hypercalcemia [see Warnings and Precautions ( 5.4 )] Hypercalciuria and Urolithiasis [see Warnings and Precautions ( 5.5 )] Osteoporosis in postmenopausal women: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.

( 6.1 ) Osteoporosis in men: The most common adverse reactions (incidence ≥2%) are injection site erythema, dizziness, arthralgia, injection site swelling, injection site pain, contusion, nausea, diarrhea, abdominal distension, abdominal pain, and bone pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Radius Health, Inc. at 1-855-672-3487 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trial in Postmenopausal Women with Osteoporosis The safety of TYMLOS was evaluated in a randomized, multicenter, double-blind, placebo-controlled clinical trial in postmenopausal women with osteoporosis aged 49 to 86 years (mean age 69 years) who were randomized to receive 80 mcg of TYMLOS (N = 824) or placebo (N = 821), given subcutaneously once daily for 18 months [see Clinical Studies ( 14.1 )] .

In this study, the incidence of all-cause mortality was 0.4% in the TYMLOS group and 0.6% in the placebo group. The incidence of serious adverse events was 10% in the TYMLOS group and 11% in the placebo group. The percentage of patients who discontinued study drug due to adverse events was 10% in the TYMLOS group and 6% in the placebo group.

The most common adverse reactions leading to study drug discontinuation in the TYMLOS group were nausea (2%), dizziness (1%), headache (1%), and palpitations (1%). Table 1 shows the most common adverse reactions in the trial. These adverse reactions were generally not present at baseline, occurred more commonly with TYMLOS than with placebo, and occurred in at least 2% of the patients treated with TYMLOS.

Table 1: Common Adverse Reactions Reported in Postmenopausal Women with Osteoporosis * * Adverse reactions reported in ≥2% of TYMLOS-treated patients. Preferred term TYMLOS (N=822) (%) Placebo (N=820) (%) Hypercalciuria 11 9 Dizziness 10 6 Nausea 8 3 Headache 8 6 Palpitations 5

0.4Fatigue 3 2 Abdominal pain upper 3 2 Vertigo 2 2 Orthostatic Hypotension In the clinical trial of women with postmenopausal osteoporosis, the incidence of orthostatic blood pressure decline ≥20 mmHg systolic or ≥10 mmHg diastolic at 1 hour after the first injection was 4% in the TYMLOS group and 3% in the placebo group. At later time points the incidence was generally similar between the treatment groups. Adverse reactions of orthostatic hypotension were reported in 1% of patients receiving TYMLOS and 0.5% of patients receiving placebo.

Dizziness was reported by more TYMLOS-treated patients (10%) compared to placebo (6%) [see Warnings and Precautions ( 5.3 )] . Tachycardia In women with postmenopausal osteoporosis, adverse reactions of tachycardia, including sinus tachycardia, were reported in 2% of patients receiving TYMLOS and 1% of patients in the placebo group. In 5 of the 13 patients receiving TYMLOS who experienced tachycardia, symptoms occurred within 1 hour of administration.

TYMLOS has been associated with a dose-dependent increase in heart rate which developed within 15 minutes after injection and resolved in about 6 hours [see Clinical Pharmacology ( 12.2 )] . Injection Site Reactions Duri… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 18 words ▾

7 DRUG INTERACTIONS No specific drug-drug interaction studies have been performed [see Clinical Pharmacology ( 12.3 )] .

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary TYMLOS is not indicated for use in females of reproductive potential. There are no human data with TYMLOS use in pregnant women to inform any drug associated risks. Animal reproduction studies with abaloparatide have not been conducted.

8.2Lactation Risk Summary TYMLOS is not indicated for use in females of reproductive potential. There is no information on the presence of abaloparatide in human milk, the effects on the breastfed infant, or the effects on milk production.

8.4Pediatric Use Safety and effectiveness of TYMLOS have not been established in pediatric patients. TYMLOS is not recommended for use in pediatric patients with open epiphyses or hereditary disorders predisposing to osteosarcoma because of an increased baseline risk of osteosarcoma [see Warnings and Precautions ( 5.2 )] .

8.5Geriatric Use Of the total number of patients in the postmenopausal osteoporosis clinical studies of TYMLOS, 82% were age 65 years and over, and 19% were age 75 years and over. In the male osteoporosis study, 74% were age 65 years and over and 23% were age 75 years or over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

8.6Renal Impairment No dosage adjustment is required for patients with mild, moderate, or severe renal impairment. A study of a single dose of TYMLOS 80 mcg given subcutaneously was conducted in subjects with normal renal function or mild, moderate, or severe renal impairment. The maximal concentration (C max ) and area under the concentration-time curve (AUC) of abaloparatide increased 1.4- and 2.1-fold, respectively, in subjects with severe renal impairment, compared to subjects with normal renal function.

Patients with severe renal impairment may have increased abaloparatide exposure that may increase the risk of adverse reactions; therefore, monitor for adverse reactions [see Clinical Pharmacology ( 12.3 )] .

🤰 Pregnancy 41 words ▾

8.1Pregnancy Risk Summary TYMLOS is not indicated for use in females of reproductive potential. There are no human data with TYMLOS use in pregnant women to inform any drug associated risks. Animal reproduction studies with abaloparatide have not been conducted.

🧒 Pediatric Use 49 words ▾

8.4Pediatric Use Safety and effectiveness of TYMLOS have not been established in pediatric patients. TYMLOS is not recommended for use in pediatric patients with open epiphyses or hereditary disorders predisposing to osteosarcoma because of an increased baseline risk of osteosarcoma [see Warnings and Precautions ( 5.2 )] .

🧓 Geriatric Use 78 words ▾

8.5Geriatric Use Of the total number of patients in the postmenopausal osteoporosis clinical studies of TYMLOS, 82% were age 65 years and over, and 19% were age 75 years and over. In the male osteoporosis study, 74% were age 65 years and over and 23% were age 75 years or over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 131 words ▾

10 OVERDOSAGE In a clinical study, accidental overdose was reported in a patient who received 400 mcg in one day (5 times the recommended clinical dose); dosing was temporarily interrupted. The patient experienced asthenia, headache, nausea, and vertigo. Serum calcium was not assessed on the day of the overdose, but on the following day the patient's serum calcium was within the normal range.

The effects of overdose may include hypercalcemia, nausea, vomiting, dizziness, tachycardia, orthostatic hypotension, and headache. Overdos age Management There is no specific antidote for TYMLOS. Treatment of suspected overdose should include discontinuation of TYMLOS, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration.

Based on the molecular weight, plasma protein binding and volume of distribution, abaloparatide is not expected to be dialyzable.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Abaloparatide is a PTHrP(1-34) analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells. Once-daily administration of abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity.

In rats and monkeys, abaloparatide had an anabolic effect on bone, demonstrated by increases in BMD and bone mineral content (BMC) that correlated with increases in bone strength at vertebral and/or nonvertebral sites [see Nonclinical Toxicology ( 13.2 )] .

12.2Pharmacodynamics Effects on Markers of Bone Turnover A dose-finding study of abaloparatide administered once daily for 24 weeks in postmenopausal women with osteoporosis demonstrated a dose-response relationship for BMD and bone formation markers. Daily administration of TYMLOS to postmenopausal women with osteoporosis for 18 months increased the bone formation marker serum procollagen type I N-propeptide (sPINP) and the bone resorption marker serum collagen type I cross-linked C-telopeptide (sCTX). The increase in geometric mean sPINP levels peaked at Month 1 at 93% above baseline in postmenopausal women then decreased slowly over time to 45% above baseline at Month 18.

The increase in geometric mean sCTX levels in postmenopausal women peaked at Month 3 at 26% above baseline then decreased to baseline levels by Month 18. Daily administration of TYMLOS to men with osteoporosis for 12 months increased the bone formation marker sPINP and the bone resorption marker sCTX. The increase in geometric mean sPINP levels peaked at Month 1 at 133% above baseline in men then decreased slowly over time to 84% above baseline at Month 12.

The increase in geometric mean sCTX levels in men peaked at Month 6 at 46% above baseline and was 35% above baseline by Month 12. Cardiac Electrophysiology A 4-way cross-over thorough QT/QTc study was conducted in 55 healthy subjects who received single doses of placebo, subcutaneous doses of abaloparatide at 80 mcg and 240 mcg (three times the recommended dose), and moxifloxacin 400 mg orally. Abaloparatide increased heart rate, with a mean peak increase of 15 beats per minute (bpm) and 20 bpm at the first time point (15 minutes) after dosing with 80 mcg and 240 mcg, respectively.

There were no clinically meaningful effects of abaloparatide on QTcI (individually corrected QT intervals) or cardiac electrophysiology.

12.3Pharmacokinetics Following seven days of subcutaneous administration of abaloparatide 80 mcg, the mean (SD) abaloparatide exposure was 812 (118) pg/mL for C max and 1622 (641) pg∙hr/mL for AUC 0–24 in postmenopausal women with osteoporosis. Absorption The median (range) time to peak concentration of abaloparatide 80 mcg was 0.51 hr (0.25 to 0.52 hr) following subcutaneous administration. The absolute bioavailability of abaloparatide in healthy women after subcutaneous administration of an 80 mcg dose was 36%.

Distribution The in vitro plasma protein binding of abaloparatide was approximately 70%. The volume of distribution was approximately 50 L. Elimination Excretion The mean (SD) half-life of abaloparatide is approximately 1 h.

The peptide fragments are primarily eliminated through renal excretion. Metabolism No specific metabolism or excretion studies have been performed with TYMLOS. The metabolism of abaloparatide is consistent with non-specific proteolytic degradation into smaller peptide fragments, followed by elimination by renal clearance.

Specific Populations Male and Female Subjects Mean serum abaloparatide concentration-time profiles observed in a study conducted in healthy men with a mean (±SD) age of 53.1 (±6.9) years were comparable to those observed in the healthy women with a mean (±SD) age of 53.7 (±7.1) years using the same dosing regimen. Geriatric Patients No age-related differences in abaloparatide pharmacokinetics were observed in men and postmen… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 90 words ▾

12.1Mechanism of Action Abaloparatide is a PTHrP(1-34) analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells. Once-daily administration of abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity.

In rats and monkeys, abaloparatide had an anabolic effect on bone, demonstrated by increases in BMD and bone mineral content (BMC) that correlated with increases in bone strength at vertebral and/or nonvertebral sites [see Nonclinical Toxicology ( 13.2 )] .

📦 How Supplied / Storage and Handling 122 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied TYMLOS (abaloparatide) injection is a clear and colorless solution, available as a pre-assembled single-patient-use disposable pen (NDC 70539-001-01) packaged in a cardboard carton (NDC 70539-001-02) with the Instructions for Use and Medication Guide. Each disposable pen embodies a glass cartridge that contains 3120 mcg of abaloparatide in 1.56 mL (2000 mcg/mL). Each pen provides a 30-day supply for once daily injection of 80 mcg abaloparatide in 40 mcL.

Sterile needles are not included.

16.2Storage and Handling Before first use, store TYMLOS under refrigeration between 2°C to 8°C (36°F to 46°F). After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F). Do not freeze or subject to heat.

📦 Storage and Handling 41 words ▾

16.2Storage and Handling Before first use, store TYMLOS under refrigeration between 2°C to 8°C (36°F to 46°F). After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F). Do not freeze or subject to heat.

📋 Description 160 words ▾

11 DESCRIPTION TYMLOS injection for subcutaneous administration contains abaloparatide, a synthetic 34 amino acid peptide. Abaloparatide is an analog of human parathyroid hormone related peptide, PTHrP(1-34). It has 41% homology to hPTH(1-34) (human parathyroid hormone 1-34) and 76% homology to hPTHrP(1-34) (human parathyroid hormone-related peptide 1-34).

Abaloparatide has a molecular formula of C 174 H 300 N 56 O 49 and a molecular weight of 3961 daltons with the amino acid sequence shown below: Ala-Val-Ser-Glu-His-Gln-Leu-Leu-His-Asp-Lys-Gly-Lys-Ser-Ile-Gln-Asp-Leu-Arg-Arg-Arg-Glu-Leu-Leu-Glu-Lys-Leu-Leu-Aib-Lys-Leu-His-Thr-Ala-NH 2 TYMLOS injection is supplied as a sterile, colorless, clear solution in a glass cartridge which is pre-assembled into a disposable single-patient-use pen. The pen is intended to deliver 30 once daily abaloparatide doses of 80 mcg in 40 mcL.

Each cartridge contains 1.56 mL of TYMLOS solution which contains 3.12 mg of abaloparatide, and the following inactive ingredients: 1.2 mg glacial acetic acid, 7.8 mg phenol, 7.92 mg sodium acetate trihydrate, and water for injection to a target pH range of 5.1 to 5.2.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Hypersensitivity Reactions Advise patients that serious hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, can occur with TYMLOS. Advise patients to discontinue TYMLOS and promptly seek immediate medical attention if signs or symptoms of hypersensitivity reactions occur [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] .

Risk of Osteosarcoma Advise patients that the active ingredient in TYMLOS, abaloparatide, caused a dose-dependent increase in the incidence of osteosarcoma in male and female rats and that it is unknown whether TYMLOS will cause osteosarcoma in humans [see Warnings and Precautions ( 5.2 )] . Instruct patients to promptly report signs and symptoms of possible osteosarcoma such as persistent localized pain or occurrence of a new soft tissue mass that is tender to palpation. Hypercalcemia Advise patients that TYMLOS may cause hypercalcemia and discuss the symptoms of hypercalcemia (e.g., nausea, vomiting, constipation, lethargy, muscle weakness) [see Warnings and Precautions ( 5.4 )] .

Instruct patients to promptly report signs and symptoms of hypercalcemia. Orthostatic Hypotension Advise patients to sit or lie down if they feel lightheaded or have palpitations after the injection until their symptoms resolve. If these symptoms persist or worsen, advise patients to consult their healthcare provider before continuing treatment [see Dosage and Administration ( 2.2 )] .

Use of TYMLOS Pen Instruct patients and caregivers who administer TYMLOS on how to properly use the TYMLOS pen and to follow sharps disposal recommendations [see Dosage and Administration ( 2.2 )] . Advise patients not to share their TYMLOS pen or needles with other patients and not to transfer the contents of the pen to a syringe. Advise patients that each TYMLOS pen can be used for up to 30 days, and after the 30-day use period, to discard the TYMLOS pen, even if it still contains unused solution [see How Supplied/Storage and Handling ( 16.2 )] .

Manufactured for: Radius Health, Inc. 22 Boston Wharf Road, 7th Floor Boston, MA 02210 TYMLOS is a registered trademark of Radius Health, Inc. Copyright © 2017, Radius Health, Inc.

All rights reserved. US-PI-000001-v12.0

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE TYMLOS ® (tim lows') (abaloparatide) injection, for subcutaneous use What is the most important information I should know about TYMLOS? TYMLOS may cause serious side effects including: Allergic (hypersensitivity) reactions, including anaphylaxis. Stop taking TYMLOS and get medical help right away if you have any of the following symptoms of an allergic reaction: swelling of your face, lips, mouth, or tongue breathing problems fainting, dizziness, feeling lightheaded (low blood pressure) fast heartbeat itching rash hives Possible bone cancer (osteosarcoma).

During animal drug testing, the medicine in TYMLOS caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take TYMLOS will have a higher chance of getting osteosarcoma. Tell your healthcare provider right away if you have pain in your bones, pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch.

What is TYMLOS? TYMLOS is a prescription medicine used to: treat osteoporosis in postmenopausal women who are at high risk for bone fracture, or who cannot use another osteoporosis treatment or other osteoporosis treatments did not work well. TYMLOS can decrease the chance of having a fracture of the spine and other bones in postmenopausal women with thinning and weakening bones (osteoporosis) increase bone density in men with osteoporosis who are at high risk for bone fracture, or who cannot use another osteoporosis treatment or other osteoporosis treatments did not work well It is not known if TYMLOS is safe and effective for children 18 years and younger.

TYMLOS should not be used in children and young adults whose bones are still growing. It is not recommended that people use TYMLOS for more than 2 years during their lifetime. Do not take TYMLOS: if you have had a severe allergic reaction to abaloparatide, or any of the other ingredients in TYMLOS.

Ask your healthcare provider if you are not sure. See the end of this Medication Guide for a complete list of ingredients in TYMLOS. Before you take TYMLOS, tell your healthcare provider about all of your medical conditions, including if you: have Paget's disease of the bone or other bone disease. have or have had cancer in your bones. have or have had radiation therapy involving your bones. have or have had too much calcium in your blood. have or have had an increase in your parathyroid hormone (hyperparathyroidism). will have trouble injecting yourself with the TYMLOS pen and do not have someone who can help you. are pregnant or plan to become pregnant.

TYMLOS is not for pregnant women. are breastfeeding or plan to breastfeed. It is not known if TYMLOS passes into your breast milk. You and your healthcare provider should decide if you will take TYMLOS or breastfeed.

You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take.

Keep a list of them to show your healthcare provider or pharmacist each time you get a new medicine. How should I use TYMLOS? Read the detailed Instructions for Use provided with your medicine.

Use TYMLOS exactly as your healthcare provider tells you to use it. Do not try to inject TYMLOS yourself until you or your caregiver receive training from a healthcare provider on the right way to use the TYMLOS pen. You should receive your first several injections of TYMLOS where you can sit or lie down, if necessary, until you know how it affects you.

Inject TYMLOS 1 time each day into your lower stomach area (abdomen) just under your skin (subcutaneous). Avoid giving your injection within the 2-inch area around your belly button (navel). Talk to your healthcare provider about how to change (rotate) your injection site for each injection.

Do not give TYMLOS in your veins (intravenously) or deep into your muscles (intramuscularly). You can take T… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Following seven days of subcutaneous administration of abaloparatide 80 mcg, the mean (SD) abaloparatide exposure was 812 (118) pg/mL for C max and 1622 (641) pg∙hr/mL for AUC 0–24 in postmenopausal women with osteoporosis. Absorption The median (range) time to peak concentration of abaloparatide 80 mcg was 0.51 hr (0.25 to 0.52 hr) following subcutaneous administration. The absolute bioavailability of abaloparatide in healthy women after subcutaneous administration of an 80 mcg dose was 36%.

Distribution The in vitro plasma protein binding of abaloparatide was approximately 70%. The volume of distribution was approximately 50 L. Elimination Excretion The mean (SD) half-life of abaloparatide is approximately 1 h.

The peptide fragments are primarily eliminated through renal excretion. Metabolism No specific metabolism or excretion studies have been performed with TYMLOS. The metabolism of abaloparatide is consistent with non-specific proteolytic degradation into smaller peptide fragments, followed by elimination by renal clearance.

Specific Populations Male and Female Subjects Mean serum abaloparatide concentration-time profiles observed in a study conducted in healthy men with a mean (±SD) age of 53.1 (±6.9) years were comparable to those observed in the healthy women with a mean (±SD) age of 53.7 (±7.1) years using the same dosing regimen. Geriatric Patients No age-related differences in abaloparatide pharmacokinetics were observed in men and postmenopausal women ranging from 18 to 85 years of age. Race No differences in abaloparatide pharmacokinetics based on race were observed in clinical trials.

Patients with Renal Impairment A single 80 mcg subcutaneous dose of abaloparatide was administered to male and female patients with renal impairment: 8 patients with mild renal impairment (CLCr 60 to 89 mL/min), 7 patients with moderate renal impairment (CLCr 30 to 59 mL/min), 8 patients with severe renal impairment (CLCr 15 to 29 mL/min), and 8 healthy subjects with normal renal function (CLCr 90 or greater mL/min) matched by sex, age, and body mass index (BMI). Abaloparatide C max increased 1.0-, 1.3-, and 1.4-fold in patients with mild, moderate, and severe renal impairment, compared to the healthy subjects with normal renal function.

Abaloparatide AUC increased 1.2-, 1.7-, and 2.1-fold in patients with mild, moderate, and severe renal impairment, compared to the healthy subjects with normal renal function. Patients undergoing dialysis were not included in the study. Drug Interactions In vitro studies showed that abaloparatide, at therapeutic concentrations, does not inhibit or induce Cytochrome P450 enzymes.

Abaloparatide is not a substrate of the renal transporters OAT1, OAT3, OCT2, MATE1, or MATE2K.

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Effects on Markers of Bone Turnover A dose-finding study of abaloparatide administered once daily for 24 weeks in postmenopausal women with osteoporosis demonstrated a dose-response relationship for BMD and bone formation markers. Daily administration of TYMLOS to postmenopausal women with osteoporosis for 18 months increased the bone formation marker serum procollagen type I N-propeptide (sPINP) and the bone resorption marker serum collagen type I cross-linked C-telopeptide (sCTX). The increase in geometric mean sPINP levels peaked at Month 1 at 93% above baseline in postmenopausal women then decreased slowly over time to 45% above baseline at Month 18.

The increase in geometric mean sCTX levels in postmenopausal women peaked at Month 3 at 26% above baseline then decreased to baseline levels by Month 18. Daily administration of TYMLOS to men with osteoporosis for 12 months increased the bone formation marker sPINP and the bone resorption marker sCTX. The increase in geometric mean sPINP levels peaked at Month 1 at 133% above baseline in men then decreased slowly over time to 84% above baseline at Month 12.

The increase in geometric mean sCTX levels in men peaked at Month 6 at 46% above baseline and was 35% above baseline by Month 12. Cardiac Electrophysiology A 4-way cross-over thorough QT/QTc study was conducted in 55 healthy subjects who received single doses of placebo, subcutaneous doses of abaloparatide at 80 mcg and 240 mcg (three times the recommended dose), and moxifloxacin 400 mg orally. Abaloparatide increased heart rate, with a mean peak increase of 15 beats per minute (bpm) and 20 bpm at the first time point (15 minutes) after dosing with 80 mcg and 240 mcg, respectively.

There were no clinically meaningful effects of abaloparatide on QTcI (individually corrected QT intervals) or cardiac electrophysiology.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Efficacy Study in Women with Postmenopausal Osteoporosis The efficacy of TYMLOS for the treatment of postmenopausal osteoporosis was evaluated in Study 003 (NCT 01343004), an 18-month, randomized, multicenter, double-blind, placebo-controlled clinical trial in postmenopausal women aged 49 to 86 years (mean age of 69) who were randomized to receive TYMLOS 80 mcg (N = 824) or placebo (N = 821) given subcutaneously once daily. Approximately 80% of patients were Caucasian, 16% were Asian, and 3% were Black; 24% were Hispanic.

At baseline, the mean T-scores were -2.9 at the lumbar spine, -2.1 at the femoral neck, and -1.9 at the total hip. At baseline, 24% of patients had at least one prevalent vertebral fracture and 48% had at least one prior nonvertebral fracture. Patients took daily supplemental calcium (500 to 1000 mg) and vitamin D (400 to 800 IU).

The efficacy study was extended as Study 005 (NCT 01657162), an open-label study where patients were no longer receiving TYMLOS or placebo but were maintained in their original randomized treatment group and received 70 mg alendronate weekly, with calcium and vitamin D supplements for 6 months. Study 005 enrolled 1139 patients, representing 92% of patients who completed Study 003. This included 558 patients who had previously received TYMLOS and 581 patients who had previously received placebo.

The cumulative 25-month efficacy dataset included 18 months of exposure to TYMLOS or placebo in Study 003, 1 month of no treatment, followed by 6 months of alendronate therapy in Study 005. Study 005 was then continued to complete 18 months of additional alendronate exposure during which time patients were no longer blinded to their original Study 003 treatment group. Effect on New Vertebral Fractures The primary endpoint was the incidence of new vertebral fractures in patients treated with TYMLOS compared to placebo.

TYMLOS resulted in a significant reduction in the incidence of new vertebral fractures compared to placebo at 18 months (0.6% TYMLOS compared to 4.2% placebo, p <0.0001). The absolute risk reduction in new vertebral fractures was 3.6% at 18 months and the relative risk reduction was 86% for TYMLOS compared to placebo ( Table 3 ). The incidence of new vertebral fractures at 25 months was 0.6% in patients treated with TYMLOS then alendronate, compared to 4.4% in patients treated with placebo then alendronate (p <0.0001).

The relative risk reduction in new vertebral fractures at 25 months was 87% for patients treated with TYMLOS then alendronate, compared to patients treated with placebo then alendronate, and the absolute risk reduction was 3.9% ( Table 3 ). After 24 months of open-label alendronate therapy, the vertebral fracture risk reduction achieved with TYMLOS therapy was maintained. Table 3: Percentage of Postmenopausal Women with Osteoporosis with New Vertebral Fractures (modified Intent to Treat Population) Includes patients who had both pre- and post-treatment spine radiographs in Study 003 Includes patients who had both pre- and post-treatment spine radiographs in Study 005 Percentage of Postmenopausal Women With Fractures Absolute Risk Reduction (%) (95% CI Confidence Interval ) Relative Risk Reduction (%) (95% CI ) TYMLOS (N=690 ) (%) Placebo (N=711 ) (%) 0-18 months 0.6 4.2 3.6 (2.1, 5.4) 86 (61, 95) TYMLOS/ Alendronate (N=544 ) (%) Placebo/ Alendronate (N=568 ) (%) 0-25 months 0.6 4.4 3.9 (2.1, 5.9) 87 (59, 96) Effect on Nonvertebral Fractures TYMLOS resulted in a significant reduction in the incidence of nonvertebral fractures at the end of the 18 months of treatment plus 1 month follow-up where no drug was administered (2.7% for TYMLOS-treated patients compared to 4.7% for placebo-treated patients).

The relative risk reduction in nonvertebral fractures for TYMLOS compared to placebo was 43% (logrank test p = 0.049) and the absolute risk reduction was 2.0%. Following 6 months of alendronate treatment in Study 005, the cumulative incidence of… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 2-year carcinogenicity study, abaloparatide was administered once daily to male and female Fischer rats by subcutaneous injection at doses of 10, 25, and 50 mcg/kg. These doses resulted in systemic exposures to abaloparatide that were 4, 16, and 28 times, respectively, the systemic exposure observed in humans following the recommended subcutaneous dose of 80 mcg (based on AUC comparisons). Neoplastic changes related to treatment with abaloparatide consisted of marked dose-dependent increases in osteosarcoma and osteoblastoma incidence in all male and female dose groups.

The incidence of osteosarcoma was 0-2% in untreated controls and reached 87% and 62% in male and female high-dose groups, respectively. The bone neoplasms were accompanied by marked increases in bone mass. The relevance of the rat findings to humans is uncertain.

The use of TYMLOS is not recommended in patients at increased risk of osteosarcoma [see Warnings and Precautions ( 5.2 )] . Mutagenesis Abaloparatide was not genotoxic or mutagenic in a standard battery of tests including the Ames test for bacterial mutagenesis, the chromosome aberration test using human peripheral lymphocytes, and the mouse micronucleus test. Impairment of Fertility Abaloparatide effects on female fertility have not been assessed nonclinically.

No adverse effects of abaloparatide on male fertility were observed in male rats. In a male rat fertility study, abaloparatide was administered via subcutaneous injection 2 weeks prior to mating, through the mating period and for approximately 2 weeks after the mating period (for total of 6 weeks) at doses of 10, 25 and 70 µg/kg/day. Abaloparatide did not cause adverse effect on mating, fertility indices, conception rate, reproductive organ weights or sperm parameters up to 70 µg/kg/day (28-fold the systemic exposure observed in humans following the recommended subcutaneous dose of 80 mcg (based on AUC comparisons).

13.2Animal Toxicology and Pharmacology In toxicity studies in rats and monkeys of up to 26-week and 39-week duration, respectively, findings included vasodilation, increases in serum calcium, decreases in serum phosphorus, and soft tissue mineralization at doses ≥10 mcg/kg/day. The 10 mcg/kg/day dose resulted in systemic exposures to abaloparatide in rats and monkeys that were 2 and 3 times, respectively, the exposure in humans at daily subcutaneous doses of 80 mcg. Pharmacologic effects of abaloparatide on the skeleton were assessed in 12- and 16-month studies in ovariectomized (OVX) rats and monkeys, at doses up to 11- and 1-times human exposure at the recommended subcutaneous dose of 80 mcg, respectively (based on AUC comparisons).

In these animal models of postmenopausal osteoporosis, treatment with abaloparatide resulted in dose-dependent increases in bone mass at vertebral and/or nonvertebral sites, correlating with increases in bone strength. The anabolic effect of abaloparatide was due to the predominant increase in osteoblastic bone formation and was evidenced by increases in trabecular thickness and/or cortical thickness due to endosteal bone apposition. Abaloparatide maintained or improved bone quality at all skeletal sites evaluated and did not cause any mineralization defects.

In an 8-week study in androgen-deficient orchiectomized (ORX) male rats, a male osteoporosis model, the effects of 5 and 25 mcg/kg/day abaloparatide (≥47-fold clinical exposures by AUC) were examined on bone formation, bone mass, and bone strength. Abaloparatide induced bone formation and improved cortical and trabecular BMD, geometry, and architecture without increasing parameters of bone resorption.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 2-year carcinogenicity study, abaloparatide was administered once daily to male and female Fischer rats by subcutaneous injection at doses of 10, 25, and 50 mcg/kg. These doses resulted in systemic exposures to abaloparatide that were 4, 16, and 28 times, respectively, the systemic exposure observed in humans following the recommended subcutaneous dose of 80 mcg (based on AUC comparisons). Neoplastic changes related to treatment with abaloparatide consisted of marked dose-dependent increases in osteosarcoma and osteoblastoma incidence in all male and female dose groups.

The incidence of osteosarcoma was 0-2% in untreated controls and reached 87% and 62% in male and female high-dose groups, respectively. The bone neoplasms were accompanied by marked increases in bone mass. The relevance of the rat findings to humans is uncertain.

The use of TYMLOS is not recommended in patients at increased risk of osteosarcoma [see Warnings and Precautions ( 5.2 )] . Mutagenesis Abaloparatide was not genotoxic or mutagenic in a standard battery of tests including the Ames test for bacterial mutagenesis, the chromosome aberration test using human peripheral lymphocytes, and the mouse micronucleus test. Impairment of Fertility Abaloparatide effects on female fertility have not been assessed nonclinically.

No adverse effects of abaloparatide on male fertility were observed in male rats. In a male rat fertility study, abaloparatide was administered via subcutaneous injection 2 weeks prior to mating, through the mating period and for approximately 2 weeks after the mating period (for total of 6 weeks) at doses of 10, 25 and 70 µg/kg/day. Abaloparatide did not cause adverse effect on mating, fertility indices, conception rate, reproductive organ weights or sperm parameters up to 70 µg/kg/day (28-fold the systemic exposure observed in humans following the recommended subcutaneous dose of 80 mcg (based on AUC comparisons).

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE TYMLOS ® (tim lows') (abaloparatide) injection, for subcutaneous use Instructions for Use Read and follow this Instructions for Use so that you inject TYMLOS pen the right way. Call your healthcare provider if you have any questions about the right way to inject the TYMLOS pen. Important information about your TYMLOS pen Do not try to inject TYMLOS yourself until you or your caregiver receive training from a healthcare provider on the right way to use TYMLOS pen.

Do not share your TYMLOS pen or pen needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Each TYMLOS pen is a prefilled pen containing 30 doses of TYMLOS.

Each dose will contain 80 mcg of TYMLOS. You do not have to measure your dose. The pen measures each dose of TYMLOS for you.

Use a new pen needle for each injection. Keep the cap on the TYMLOS pen when not using the pen. Before using the pen always check the label to be sure it is your TYMLOS pen.

Do not use your TYMLOS pen if it looks damaged. If you drop your TYMLOS pen or it becomes damaged, call your healthcare provider or pharmacist or call 1-855-672-3487. To clean your TYMLOS pen, wipe the outside of the pen with a clean, damp cloth, if needed.

The TYMLOS pen is not recommended for use by the blind or visually impaired without the help of a person trained in the right way to use the pen. Pen needles to use with your TYMLOS pen Pen needles are not included with your TYMLOS pen. You will need a prescription from your healthcare provider to get pen needles from your pharmacy.

The correct needles to use with your TYMLOS pen are 5 to 8 mm, 31-gauge needles. Compatible needles include Clickfine®, BD Ultra-Fine™, MedtFine®, Easy Comfort, Clever Choice™ Comfort EZ™, and SureComfort™. If you are not sure what type of needle to use, ask your healthcare provider or pharmacist.

Supplies you will need for each injection using your TYMLOS pen 1 TYMLOS pen 1 pen needle 1 alcohol swab 1 cotton ball or gauze pad 1 sharps disposal container for pen needles and TYMLOS pens. See " How should I throw away (dispose) of the pen needles and TYMLOS pens? " in the far right column. How should I store the TYMLOS pen?

Before first use, store TYMLOS pens in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not store pens with the needle attached. Do not freeze the TYMLOS pen or expose it to heat.

During 30 days of use: After first use, store the TYMLOS pen for up to 30 days at room temperature between 68°F to 77°F (20°C to 25°C). Keep the pen cap on your TYMLOS pen when storing. Do not store the TYMLOS pen with needle attached.

Use your TYMLOS pen for only 30 days. Write down the date of your first use of TYMLOS here: _____/_____/_____. Throw away your TYMLOS pen 30 days after first opening it even if it still contains unused medicine.

Keep the TYMLOS pen, pen needles and all medicines out of the reach of children. How should I throw away (dispose) of the pen needles and TYMLOS pens? Throw away (dispose of) your TYMLOS pen, in a FDA-cleared sharps disposal container or puncture resistant container, 30 days after first opening it even if it still contains unused medicine.

Put your used pen needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) your used sharps disposal container in your household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 9 words ▾

Warnings and Precautions, Hypersensitivity Reactions ( 5.1 ) 08/2026

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Label NDC 70539-001-01 Rx only Read Instructions for Use BEFORE injecting. Date of first use ________/________/________. Discard unused portion 30 days after first opening.

TYMLOS ® (abaloparatide) injection 80 mcg per dose 3120 mcg/1.56 mL (2000 mcg/mL) For subcutaneous use For Single Patient Use Only Each prefilled pen will deliver 30 subcutaneous doses. Before first use, keep in refrigerator at 2°C – 8°C (36°F – 46°F). After first use, store for up to 30 days at 20°C – 25°C (68°F – 77°F).

Do not freeze or subject to heat. Mfg. for: Radius Health, Inc. Boston, MA 02210 USA 10006074-04 Lot: Exp.: PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Label

PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Box NDC 70539-001-02 TYMLOS ® (abaloparatide) injection 80 mcg per dose 3120 mcg/1.56 mL (2000 mcg/mL) For subcutaneous use For Single Patient Use Only Rx only Sterile 1 prefilled pen Needles not included Each prefilled pen will deliver 30 subcutaneous doses. Dispense the enclosed Medication Guide and Instructions for Use to each patient. PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Box

PRINCIPAL DISPLAY PANEL - Sample 80 mcg Prefilled Pen Label NDC 70539-001-99 Rx only Read Instructions for Use BEFORE injecting. Date of first use ________/________/________. Discard unused portion 30 days after first opening.

TYMLOS ® (abaloparatide) injection SAMPLE—NOT FOR SALE 80 mcg per dose 3120 mcg/1.56 mL (2000 mcg/mL) For subcutaneous use For Single Patient Use Only Each prefilled pen will deliver 30 subcutaneous doses. Before first use, keep in refrigerator at 2°C – 8°C (36°F – 46°F). After first use, store for up to 30 days at 20°C – 25°C (68°F – 77°F).

Do not freeze or subject to heat. Mfg. for: Radius Health, Inc. Boston, MA 02210 USA 10006645-04 Lot: Exp.: PRINCIPAL DISPLAY PANEL - Sample 80 mcg Prefilled Pen Label

PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Box - Sample NDC 70539-001-98 TYMLOS ® (abaloparatide) injection 80 mcg per dose 3120 mcg/1.56 mL (2000 mcg/mL) For subcutaneous use For Single Patient Use Only Sterile Rx only SAMPLE—NOT FOR SALE 1 prefilled pen Needles not included Each prefilled pen will deliver 30 subcutaneous doses. Dispense the enclosed Medication Guide and Instructions for Use to each patient. PRINCIPAL DISPLAY PANEL - 80 mcg Prefilled Pen Box - Sample

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 cartridge70539-0001-02 6,208 Rx · $18,414,028
1 cartridge this page70539-0001-98 No Medicaid data
Drug total (last 4 qtrs): 6,208 Rx · 10,288 units · $18,414,028 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Tymlos — 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 Tymlos. 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
$109.14M
Claims incl. refills
34.1K
Beneficiaries
15.7K
Spend / beneficiary
$6,952.94
Spend / claim
$3,198.06
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 Tymlos (this brand).

Top reported reactions

Headache5,123
Nausea3,913
Dizziness3,860
Fatigue3,419
Heart Rate Increased2,593
Arthralgia2,343
Palpitations2,225

Reporter sex

29,258 reports

Serious outcomes

Death313
Disabling45
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,306 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Radius Health, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 cartridge (70539-0001-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Radius Health, 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.
← 70537-0986-02 · The 70539-0400-04 · Radius →
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.