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Doptelet Sprinkle avatrombopag 10 mg Granule, 30-count — NDC 71369-0010-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Doptelet Sprinkle avatrombopag 10 mg Granule, 30-count — NDC 71369-010-30 (Billing 71369-0010-30)

by AkaRx, Inc. · 1 BOTTLE in 1 CARTON / 30 GRANULE in 1 BOTTLE

This is a package of 30 granules of Doptelet Sprinkle avatrombopag 10 mg Granule from AkaRx, Inc., marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 71369-0010-30
🏷️ FDA NDC (as labeled) 71369-010-30 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 71369-010-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71369 labeler · 010 product · 30 package
Package marketed since
Jul 25, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 7136901030 7
Medicaid fills, this package
14 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71369-010-30
Product NDC 71369-010
11-digit billing NDC 71369001030
NCPDP billing unit EA — each (per item)
RxCUI 2045951, 2045952, 2045958, 2045959, 2045960, 2045961, 2721188, 2721192
UNII GDW7M2P1IS
Application # NDA219696
SPL Set ID e2d5960d-6c18-46cc-86bd-089222b09852
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-25
Route ORAL
Dosage form GRANULE
Substance AVATROMBOPAG MALEATE

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

GPI-14 82405010206820
GCN Seq No 088262
GCN 58367
HICL code 044942
Ingredient (HICL) Avatrombopag Maleate
HIC1 code N
Therapeutic class — broad (HIC1) Bone Marrow
HIC2 code N1
Therapeutic class — intermediate (HIC2) Affecting Blood, Non-Iron Hematinics And Others
HIC3 code N1F
Therapeutic class — specific (HIC3) Thrombopoietin Receptor Agonists
AHFS code 20:16.00.00
AHFS class Hematopoietic Agents
FDB label name DOPTELET SPRINKLE 10 MG CAP
FDB brand name Doptelet Sprinkle
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088262
  • GCN: 58367
  • GPI-14 (Medi-Span): 82405010206820
  • HICL (First Databank): 044942
  • AHFS class code: 20:16.00.00
  • RxCUI (RxNorm): 2045951
Why two NDCs? The FDA registers this code as 71369-010-30 — 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 → 71369-0010-30. 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 Other systemic hemostatics class.

Drug family (ATC) Other systemic hemostatics
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 DOPTELET SPRINKLE 10 MG CAP Ingredient Avatrombopag Maleate
📗 Our plain-language guide HelloPharmacist
  • It raises low platelet counts. You may be taking it before a procedure if you have chronic liver disease, or long term if you have immune thrombocytopenia (ITP) that hasn't respond...
  • Take it by mouth once a day with food, just as prescribed. If you're using Doptelet Sprinkle, open the capsule, mix the granules into a soft food or liquid, and take or give it rig...
  • Platelet counts begin to rise in about 3 to 5 days and peak around 10 to 13 days. That's why, for a procedure, you start about 10 to 13 days ahead. With ITP, regular blood tests gu...
  • Headache and tiredness are common. Some people also get fever, nausea, belly pain, swelling, bruising, nosebleeds, or cold-like symptoms. Tell me if any of these bother you or get...
📖 Read our full Avatrombopag guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $435.80 —
Medicare drug plans payPart D · Q2 2026 $458.56 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71369-0010-30 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 30 GRANULE in 1 BOTTLE 2025-07-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Doptelet Sprinkle 10 mgthis 71369-0010-30 AkaRx, 30 granules — — 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

🏛️
2025
First FDA approval
Jul 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2032
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 Jul 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 24, 2025 RLD RS ⏳ ~5.8 yr to latest listed protection

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

Patents & exclusivity — FDA Orange Book
US 7638536 — drug substance
Exclusivity NP
Exclusivity ODE-548
2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

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

Listed patents (1)
PatentTypeUse codeExpires
US 7638536 ↗ Drug substance — Jul 28, 2027
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductJul 24, 2028
ODE-548Orphan Drug Exclusivity (7-year)Jul 24, 2032
Common questions
Is there a generic version of DOPTELET SPRINKLE 10 MG CAP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for DOPTELET SPRINKLE 10 MG CAP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jul 2032 — an estimate, not a guaranteed launch date.
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.

What it looks like

Color yellow
ShapeRound
ImprintAVA;20
Size8 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

🧪 Avoiding an ingredient? See Avatrombopag 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.

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.

5 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

LabelerAkaRx, Inc.
Application holderAKARX INC
FDA applicationNDA219696 (NDA)
Labeler code71369
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from AkaRx, Inc. labeler code 71369

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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 200 words ▾

1 INDICATIONS AND USAGE DOPTELET is a thrombopoietin receptor agonist indicated for the treatment of: Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. ( 1.1 ) Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. ( 1.2 ) Thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment ( 1.3 )

1.1Treatment of Thrombocytopenia in Patients with Chronic Liver Disease (CLD) DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

1.2Treatment of Thrombocytopenia in Adult Patients with Chronic Immune Thrombocytopenia (ITP) DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

1.3Treatment of Thrombocytopenia in Pediatric Patients 1 Year and Older with Persistent or Chronic Immune Thrombocytopenia (ITP) DOPTELET is indicated for the treatment of thrombocytopenia in pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION DOPTELET tablets and DOPTELET SPRINKLE are not substitutable on a mg-to-mg basis. DOPTELET SPRINKLE capsules should be opened, and the contents (oral granules) mixed with a soft food or liquid. Administer immediately after mixing.

Do not swallow the capsules whole. Administer DOPTELET tablets and DOPTELET SPRINKLE with food. ( 2.1 , 2.3 , 2.5 ) Chronic Liver Disease : Dose DOPTELET tablets based upon platelet count prior to procedure, orally for 5 days beginning 10 days to 13 days before procedure.

For platelet count less than 40×10 9 /L, the dose is 60 mg (3 tablets) orally once daily; for platelet count 40 to less than 50×10 9 /L the dose is 40 mg (2 tablets) orally once daily. ( 2.2 ) Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or Chronic Immune Thrombocytopenia : Initiate DOPTELET tablets at 20 mg (1 tablet) orally once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50×10 9 /L.

Do not exceed 40 mg (2 tablets) per day. Pediatric Patients 1 Year to Less than 6 Years with Persistent or Chronic Immune Thrombocytopenia : Initiate DOPTELET SPRINKLE oral granules at 10 mg (content of 1 capsule) orally once daily. Adjust the dose or frequency of dosing to maintain platelet count greater than or equal to 50×10 9 /L.

Do not exceed 20 mg (content of 2 capsules) per day.

2.1Important Use and Administration Instructions Select the recommended product (DOPTELET tablets or DOPTELET SPRINKLE) based on the indication and patient’s age. Administer DOPTELET tablets and DOPTELET SPRINKLE with food. DOPTELET tablets and DOPTELET SPRINKLE are not substitutable on a mg-to-mg basis.

The mixture prepared from the granules in DOPTELET SPRINKLE capsules is more bioavailable than DOPTELET tablets [see Clinical Pharmacology ( 12.3 )] . There is no experience from clinical trials in switching between dosing with the granules and the tablet. If the formulation is switched, monitor platelet counts weekly until stable platelet counts are obtained and adjust dosing as needed before resuming monthly monitoring.

2.2Recommended Dosage of DOPTELET Tablets for Patients with Chronic Liver Disease Begin DOPTELET tablets dosing 10 days to 13 days prior to the scheduled procedure. The recommended daily dose of DOPTELET is based on the patient’s platelet count prior to the scheduled procedure (see Table 1 ). Patients should undergo their procedure 5 days to 8 days after the last dose of DOPTELET.

DOPTELET tablets should be taken orally once daily for 5 consecutive days with food. All 5 days of dosing should be completed. Table 1 : Recommended DOPTELET Tablets Dosage and Duration in Patients with Chronic Liver Disease Scheduled to Undergo a Procedure Platelet Count Recommended DOPTELET Dosage Duration Less than 40×10 9 /L 60 mg (3 tablets) orally once daily 5 days 40×10 9 /L to less than 50×10 9 /L 40 mg (2 tablets) orally once daily 5 days DOPTELET tablets have been investigated only as a single 5-day once daily dosing regimen in clinical trials in patients with chronic liver disease [ see Clinical Studies ( 14.1 ) ] .

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts. Monitoring : Obtain a platelet count prior to administration of DOPTELET therapy and on the day of a procedure to ensure an adequate increase in platelet count.

2.3Recommended Dosage of DOPTELET Tablets for Adult Patients with Chronic Immune Thrombocytopenia and Pediatric Patients 6 Years and Older with Persistent or Chronic Immune Thrombocytopenia Use the lowest dose of DOPTELET needed to achieve and maintain a platelet count greater than or equal to 50×10 9 /L as necessary to reduce the risk for bleeding. Dose adjustments are based on platelet count response. Do not use DOPTELET to normalize platelet counts.

Initial Dosage : Begin DOPTELET tablets at an initial dosage of 20 mg (1 tablet)… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 79 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets DOPTELET Tablets: 20 mg as round, biconvex, yellow, film-coated tablets debossed with “AVA” on one side and “20” on the other side. Oral Granules DOPTELET SPRINKLE: 10 mg as Size 0 capsules containing white to off-white granules. The capsules have a white opaque body and light blue opaque cap with a black arrow symbol imprinted on the body and cap. Tablet: 20 mg ( 3 ) Oral Granules: 10 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Thrombotic/Thromboembolic Complications: DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or immune thrombocytopenia. Monitor platelet counts. Monitor for signs and symptoms of thromboembolic events and institute treatment promptly. ( 5.1 )

5.1Thrombotic/Thromboembolic Complications DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or immune thrombocytopenia. In patients with chronic liver disease, thromboembolic events (portal vein thrombosis) occurred in 0.4% (1/274) of patients receiving DOPTELET. In adult patients with chronic immune thrombocytopenia, thromboembolic events (arterial or venous) occurred in 7% (9/128) of patients receiving DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (e.g., Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency) and acquired risk factors (e.g., antiphospholipid syndrome). DOPTELET should not be administered to patients with chronic liver disease or immune thrombocytopenia in an attempt to normalize platelet counts. Monitor platelet counts and follow the dosing guidelines to achieve target platelet counts [see Dosage and Administration ( 2.3 and 2.5 )] .

Monitor patients receiving DOPTELET for signs and symptoms of thromboembolic events and institute treatment promptly.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: Thrombotic/Thromboembolic Complications [ see Warnings and Precautions ( 5.1 ) ] In adult patients with chronic liver disease, the most common adverse reactions (≥3%) were pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral. ( 6.1 ) In adult patients with chronic immune thrombocytopenia, the most common adverse reactions (≥10%) were headache, fatigue, contusion, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae and nasopharyngitis.

( 6.1 ) In pediatric patients with persistent or chronic immune thrombocytopenia, the most common adverse reactions (≥10%) were viral infection, nasopharyngitis, cough, pyrexia, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sobi, Inc. at 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Patients with Chronic Liver Disease The safety of DOPTELET was evaluated in two international, identically designed, randomized, double-blind, placebo-controlled trials, ADAPT-1 and ADAPT-2, in which 430 patients with chronic liver disease and thrombocytopenia received either DOPTELET (n=274) or placebo (n=156) daily for 5 days prior to a scheduled procedure, and had 1 post-dose safety assessment.

Patients were divided into two groups based on their mean platelet count at baseline: Low Baseline Platelet Count Cohort (less than 40×10 9 /L) who received DOPTELET 60 mg once daily for 5 days High Baseline Platelet Count Cohort (40 to less than 50×10 9 /L) who received DOPTELET 40 mg once daily for 5 days The majority of patients were males (65%) and median subject age was 58 years (ranging from 19-86 years of age). The racial and ethnic distribution was White (60%), Asian (33%), Black (3%) and Other (3%). The most common adverse reactions (those occurring in ≥3% of patients) in the DOPTELET-treated groups (60 mg or 40 mg) across the pooled data from the two trials are summarized in Table 8.

Table 8 : Adverse Reactions with a Frequency ≥3% in Patients with C hronic L iver D isease Treated with DOPTELET – Pooled Data ADAPT-1 and ADAPT-2 Adverse Reactions Low Baseline Platelet Count Cohort (˂40 × 10 9 /L) High Baseline Platelet Count Cohort (≥40 to ˂50 × 10 9 /L) Combined Baseline Platelet Count Cohort s (˂ 5 0 × 10 9 /L) DOPTELET 60 mg (N=159) % Placebo (N=91) % DOPTELET 40 mg (N=115) % Placebo (N=65) % Total DOPTELET (N=274) % Total Placebo (N=156) % Pyrexia 11 9 8 9 10 9 Abdominal Pain 6 7 7 6 7 6 Nausea 6 8 7 6 7 7 Headache 4 8 7 5 6 6 Fatigue 4 4 3 2 4 3 Edema Peripheral 3 2 4 2 3 2 For the Low Baseline Platelet Count Cohort, the incidence of serious adverse reactions was 7% (11/159) in the 60 mg DOPTELET treatment group.

For the High Baseline Platelet Count Cohort, the incidence of serious adverse reactions was 8% (9/115) in the 40 mg DOPTELET treatment group. The most common serious adverse reaction reported with DOPTELET was hyponatremia. Two DOPTELET-treated patients (0.7%) developed hyponatremia.

Adverse reactions resulting in discontinuation of DOPTELET were anemia, pyrexia, and myalgia; each was reported in a single (0.4%) patient in the DOPTELET (60 mg) treatment group. Adult Patients with Chronic Immune Thrombocytopenia The safety of DOPTELET was evaluated in four clinical trials in adult patients with chronic immune thrombocytopenia: two Phase 3 trials (one randomized, double-blind, placebo-controlled trial, and one randomized, double-blind, active-controlled trial) and two Phase 2 trials (one randomized, double-blind, placebo-controlled, dose-ranging, trial, and one open-label extens… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Moderate or Strong Dual CYP2C9 and CYP3A4 Inducers or Inhibitors: Dose adjustments are recommended for patients with persistent or chronic immune thrombocytopenia. ( 7.1 )

7.1Effect of Other Drugs on DOPTELET in Patients with Persistent or Chronic Immune Thrombocytopenia Moderate or Strong Dual Inhibitors of CYP2C9 and CYP3A4 Concomitant use with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4 increases avatrombopag AUC [ see Clinical Pharmacology ( 12.3 )] , which may increase the risk of DOPTELET toxicities. Reduce the starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inhibitor of CYP2C9 and CYP3A4 (see Table 4 and Table 7) [ see Dosage and Administration ( 2.4 and 2.6 )] .

In patients starting moderate or strong dual inhibitors of CYP2C9 and CYP3A4 while receiving DOPTELET, monitor platelet counts and adjust DOPTELET dose as necessary (see Table 2 and Table 3; and Table 5 and Table 6) [ see Dosage and Administration ( 2.3 and 2.5 )] . Moderate or Strong Dual Inducers of CYP2C9 and CYP3A4 Concomitant use with a moderate or strong dual inducer of CYP2C9 and CYP3A4 decreases avatrombopag AUC [ see Clinical Pharmacology ( 12.3 )] , which may reduce DOPTELET efficacy. Increase the recommended starting dosage of DOPTELET when used concomitantly with a moderate or strong dual inducer of CYP2C9 and CYP3A4 (see Table 4 and Table 7) [ see Dosage and Administration ( 2.4 and 2.6 )] .

In patients starting moderate or strong dual inducers of CYP2C9 and CYP3A4 while receiving DOPTELET, monitor platelet counts and adjust DOPTELET dose as necessary (see Table 2 and Table 3; and Table 5 and Table 6) [ see Dosage and Administration ( 2.3 and 2.5 )] . Patients with Chronic Liver Disease No dosage adjustments are required for patients with chronic liver disease.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm ( 8.1 ) Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal reproduction studies, DOPTELET may cause fetal harm when administered to a pregnant woman ( see Data ). The available data on DOPTELET in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, oral administration of avatrombopag resulted in adverse developmental outcomes when administered during organogenesis in rabbits and during organogenesis and the lactation period in rats.

However, these findings were observed at exposures based on an AUC substantially higher than the AUC observed in patients at the maximum recommended dose of 60 mg once daily. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryo-fetal development studies, avatrombopag was administered during organogenesis at doses of 100, 300, and 1000 mg/kg/day in rats and doses of 100, 300, and 600 mg/kg/day in rabbits.

Minimal decreases in fetal weights were observed in rats at the maternally toxic dose of 1000 mg/kg/day with exposures 190 times the human exposure based on AUC. Spontaneous abortions were observed at all doses tested in rabbits and were associated with decreased body weights and food consumption at 300 and 600 mg/kg/day; exposures at the lowest dose of 100 mg/kg/day were 10 times the AUC in patients at the maximum recommended dose of 60 mg once daily. There were no embryo-fetal effects in rats administered avatrombopag at doses up to 100 mg/kg/day (53 times the human exposure based on AUC) or rabbits administered avatrombopag at doses up to 600 mg/kg (35 times the human exposure based on AUC).

In pre- and postnatal development studies in rats, avatrombopag was administered during both the organogenesis and lactation periods at doses ranging from 5 to 600 mg/kg/day. Doses of 100, 300, and 600 mg/kg/day caused maternal toxicity leading to total litter losses, decreased body weight in pups, and increased pup mortality, with the majority of the pup mortality occurring from postnatal days 14 to 21. At a dose of 50 mg/kg/day that did not produce clear maternal toxicity, avatrombopag caused increased pup mortality from postnatal days 4 to 21, and mortality continued through postnatal day 25.

The 50 mg/kg/day dose also decreased body weight gain in the pups, resulting in a delay in sexual maturation. There were no effects on behavioral or reproductive functions in the offspring. The 50 mg/kg/day dose resulted in maternal exposures 43 times and pup exposures approximately 3 times the AUC observed in patients at the maximum recommended dose of 60 mg once daily.

8.2Lactation Risk Summary There is no information regarding the presence of avatrombopag in human milk, the effects on the breastfed child, or the effects on milk production. Avatrombopag was present in the milk of lactating rats. When a drug is present in animal milk, it is likely the drug will be present in human milk.

Due to the potential for serious adverse reactions in a breastfed child from DOPTELET, breastfeeding is not recommended during treatment with DOPTELET and for at least 2 weeks after the last dose ( see Clinical Considerations ). Clinical Considerations Minimizing Exposure A lactating woman receiving DOPTELET for brief periods, such as prior to an invasive procedure, should interrupt breastfeeding and pump and discard breastmilk during treatment and for two weeks after the last dose of DOPTELET in order to minimize exposure to a breastfed child.

Ad… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal reproduction studies, DOPTELET may cause fetal harm when administered to a pregnant woman ( see Data ). The available data on DOPTELET in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, oral administration of avatrombopag resulted in adverse developmental outcomes when administered during organogenesis in rabbits and during organogenesis and the lactation period in rats.

However, these findings were observed at exposures based on an AUC substantially higher than the AUC observed in patients at the maximum recommended dose of 60 mg once daily. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryo-fetal development studies, avatrombopag was administered during organogenesis at doses of 100, 300, and 1000 mg/kg/day in rats and doses of 100, 300, and 600 mg/kg/day in rabbits.

Minimal decreases in fetal weights were observed in rats at the maternally toxic dose of 1000 mg/kg/day with exposures 190 times the human exposure based on AUC. Spontaneous abortions were observed at all doses tested in rabbits and were associated with decreased body weights and food consumption at 300 and 600 mg/kg/day; exposures at the lowest dose of 100 mg/kg/day were 10 times the AUC in patients at the maximum recommended dose of 60 mg once daily. There were no embryo-fetal effects in rats administered avatrombopag at doses up to 100 mg/kg/day (53 times the human exposure based on AUC) or rabbits administered avatrombopag at doses up to 600 mg/kg (35 times the human exposure based on AUC).

In pre- and postnatal development studies in rats, avatrombopag was administered during both the organogenesis and lactation periods at doses ranging from 5 to 600 mg/kg/day. Doses of 100, 300, and 600 mg/kg/day caused maternal toxicity leading to total litter losses, decreased body weight in pups, and increased pup mortality, with the majority of the pup mortality occurring from postnatal days 14 to 21. At a dose of 50 mg/kg/day that did not produce clear maternal toxicity, avatrombopag caused increased pup mortality from postnatal days 4 to 21, and mortality continued through postnatal day 25.

The 50 mg/kg/day dose also decreased body weight gain in the pups, resulting in a delay in sexual maturation. There were no effects on behavioral or reproductive functions in the offspring. The 50 mg/kg/day dose resulted in maternal exposures 43 times and pup exposures approximately 3 times the AUC observed in patients at the maximum recommended dose of 60 mg once daily.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of DOPTELET tablet for the treatment of persistent or chronic ITP have been established in pediatric patients aged 6 years and older. The safety and effectiveness of DOPTELET SPRINKLE for the treatment of persistent or chronic ITP have been established in pediatric patients aged 1 to <6 years. Use of DOPTELET tablet and DOPTELET SPRINKLE for their respective populations is supported by evidence from an adequate and well-controlled study in pediatric patients aged 1 year and older [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.3 )] .

Juvenile Animal Toxicity Data In a 10-week juvenile toxicology study in rats, avatrombopag was administered at doses ranging from 20 to 300 mg/kg/day. There was no test article-related mortality and there were no clinical signs at doses up to 300 mg/kg/day. In the stomach, dose-dependent degeneration, regenerative hyperplasia, and atrophy of the glandular epithelium occurred at 100 and 300 mg/kg/day; exposures at 100 mg/kg/day in male rats were 14 times the AUC in patients at the highest recommended dose of 60 mg once daily.

An increased incidence of background focal mineralization was also observed in the kidneys of females at 300 mg/kg/day (female rat exposure was 50 times the human exposure based on AUC at the 60 mg daily dose).

🧓 Geriatric Use 103 words ▾

8.5Geriatric Use There were 112 patients 65 years of age and older in the clinical studies for Chronic Liver Disease and Chronic Immune Thrombocytopenia [see Clinical Studies ( 14.1 and 14.2 )] . Of the total number of DOPTELET-treated patients in these studies, 71 (23%) were 65 years of age and older, while 12 (4%) were 75 years of age and older. Clinical studies of DOPTELET did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 83 words ▾

10 OVERDOSAGE In the event of overdose, platelet count may increase excessively and result in thrombotic or thromboembolic complications. Closely monitor the patient and platelet count. Treat thrombotic complications in accordance with standard of care.

No antidote for DOPTELET overdose is known. Hemodialysis is not expected to enhance the elimination of DOPTELET because avatrombopag is only approximately 6% renally excreted and is highly bound to plasma proteins. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Avatrombopag is an orally bioavailable, small molecule TPO receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.

12.2Pharmacodynamics Platelet Response DOPTELET tablet administered to adult patients resulted in dose- and exposure-dependent elevations in platelet counts. The onset of the platelet count increase was observed within 3 to 5 days of the start of treatment, with peak effect after 10 to 13 days. Post treatment, platelet counts decreased gradually, returning to near baseline values.

Cardiac Electrophysiology At exposures similar to that achieved at the 40 mg and 60 mg tablet dose, DOPTELET did not prolong the QT interval to any clinically relevant extent. Mean QTc prolongation effects >20 ms are not anticipated with the highest recommended therapeutic dosing regimen based on analysis of data from the pooled clinical trials in patients with chronic liver disease.

12.3Pharmacokinetics The pharmacokinetics of avatrombopag were determined following administration of DOPTELET tablets, and pharmacokinetic parameters are presented as geometric mean (CV%) unless otherwise specified. Avatrombopag demonstrated dose-proportional pharmacokinetics after single doses from 10 mg (0.5 times the lowest approved dosage) to 80 mg (1.3 times the highest recommended dosage). Healthy subjects administered 40 mg of avatrombopag had a geometric mean (%CV) maximal concentration (C max ) of 166 (84%) ng/mL and area under the time-concentration curve extrapolated to infinity (AUC 0-inf ) of 4198 (83%) ng.hr/mL.

The pharmacokinetics of avatrombopag were similar in both healthy subjects and the chronic liver disease population. The relative bioavailability of DOPTELET SPRINKLE compared to DOPTELET tablet has not been studied. However, a prototype of DOPTELET SPRINKLE demonstrated a 22% higher geometric mean C max and a 38% higher geometric mean AUC for avatrombopag compared to DOPTELET tablet, both administered to healthy adult subjects under the fed condition.

Table 11 summarizes avatrombopag exposure in a virtual adult population and in pediatric patients with persistent or chronic immune thrombocytopenia. Table 11: Summary of Avatrombopag Exposure in a Virtual Adult Population and Pediatric Patients with Persistent or Chronic Immune Thrombocytopenia Cohort Adults 20 mg daily DOPTELET tablet ≥12 to <18 years N=21 20 mg daily DOPTELET tablet ≥6 to <12 years N=20 20 mg daily DOPTELET tablet ≥1 to <6 years N=12 10 mg daily DOPTELET SPRINKLE C max,ss (ng/mL) Geometric mean (CV) 165 (61.3) 168 (36.7) 267 (25.7) 221 (35.6) AUC ss (ng × h/mL) Geometric mean (CV) 3277 (62.2) 3372 (41.5) 4942 (28.7) 4030 (38.6) AUC ss = area under the concentration time curve at steady-state; C max,ss = maximal concentration at steady-state; CV = coefficient of variation expressed as a percent; N = number of individuals.

Absorption The median time to maximal concentration (T max ) occurred at 5 to 6 hours post-dose. Effect of Food Avatrombopag AUC 0-inf and C max were not affected when DOPTELET tablets were co-administered with a low-fat meal (500 calories, 3 g fat, 15 g protein, and 108 g carbohydrates) or a high-fat meal (918 calories, 59 g fat, 39 g protein, and 59 g carbohydrates). The variability of avatrombopag exposure was reduced by 40% to 60% with food.

The T max of avatrombopag was delayed by 0 to 2 hours when DOPTELET tablets were administered with a low-fat or high-fat meal (median T max range 5 to 8 hours) compared to the fasted state. Geometric mean exposure increased by approximately 19% and 32% for C max and AUC, respectively, when a prototype of DOPTELET SPRINKLE was administered in the fed state compared to the fasted state, and between-subject variability e… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 55 words ▾

12.1Mechanism of Action Avatrombopag is an orally bioavailable, small molecule TPO receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.

📦 How Supplied / Storage and Handling 190 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1DOPTELET Tablets DOPTELET 20 mg tablets are supplied as round, biconvex, yellow, film-coated tablets, and debossed with “AVA” on one side and “20” on the other side. How Supplied Carton NDC Blister Card NDC Carton of one blister card with 10 tablets NDC 71369-020-10 NDC 71369-020-11 Carton of one blister card with 15 tablets NDC 71369-020-15 NDC 71369-020-16 Carton of two blister cards, each with 15 tablets (30 tablets total) NDC 71369-020-30 NDC 71369-020-16 Store DOPTELET tablets at room temperature from 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F).

Store tablets in the original package.

16.2DOPTELET SPRINKLE DOPTELET SPRINKLE is supplied as 10 mg capsules with a white opaque body and light blue opaque cap with a black arrow symbol imprinted on the body and cap. The capsule is filled with white to off-white granules. How Supplied Carton and Bottle NDC Carton with one bottle of 30 capsules (containing oral granules) NDC 71369-010-30 Store DOPTELET SPRINKLE capsules at room temperature from 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F).

📋 Description 179 words ▾

11 DESCRIPTION The active ingredient in DOPTELET is avatrombopag maleate, a thrombopoietin receptor agonist. The chemical name of avatrombopag maleate is 4-piperidinecarboxylic acid, 1-[3-chloro-5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-2-pyridinyl]-, (2Z)-2-butenedioate (1:1). It has the molecular formula C 29 H 34 Cl 2 N 6 O 3 S 2 · C 4 H 4 O 4 .

The molecular weight is 765.73. The structural formula is: The aqueous solubility of avatrombopag maleate at various pH levels indicates that the drug substance is practically insoluble at pH 1 to 11. DOPTELET is provided as an immediate-release tablet and as a sprinkle capsule that contains oral granules.

Each DOPTELET tablet contains 20 mg avatrombopag (equivalent to 23.6 mg of avatrombopag maleate) and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Coating film: ferric oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Each DOPTELET SPRINKLE capsule contains 10 mg avatrombopag (equivalent to 11.8 mg of avatrombopag maleate) and the following inactive ingredients: crospovidone Type A, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate.

Capsule shells: Hypromellose. image description

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling: Patient Information and, for DOPTELET SPRINKLE, Instructions for Use. Prior to treatment, patients should fully understand and be informed of the following risks and considerations for DOPTELET: Risks Thrombotic/Thromboembolic Complications DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or immune thrombocytopenia.

Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. Various thromboembolic complications (arterial and venous) have been reported in patients treated with DOPTELET [ see Warnings and Precautions ( 5.1 )] . Drug Interactions DOPTELET may be affected by other drugs and may require a dose adjustment when co-administered with other drugs; therefore, advise patients to report their use of any other prescription or nonprescription medications or dietary supplements [ see Dosage and Administration ( 2.4 and 2.6 ), Drug Interactions ( 7 )] .

Pregnancy Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [ see Use in Specific Populations ( 8.1 )] . Lactation Advise women not to breastfeed during treatment with DOPTELET and for at least 2 weeks after the last dose [ see Use in Specific Populations ( 8.2 ) ] .

Administration Instructions for DOPTELET SPRINKLE Inform patients and caregivers to open the capsules and mix the contents with the recommended soft foods or liquids. Administer immediately after mixing. Do not swallow the capsules whole.

Do not chew or crush the granules. Advise patients and caregivers to read and follow the Instructions for Use for DOPTELET SPRINKLE. DOPTELET and DOPTELET SPRINKLE are not substitutable on a milligram-to-milligram basis Advise patients and caregivers that DOPTELET and DOPTELET SPRINKLE are not substitutable on a milligram-to-milligram basis.

To avoid a dosing error from using the wrong dosage form, strongly advise patients and caregivers to visually inspect the product to verify the correct dosage form each time the prescription is filled. DOPTELET is a registered trademark of AkaRx, Inc. Manufactured for AkaRx, Inc., Morrisville, North Carolina 27560 ©2025 For more information, go to www.DOPTELET.com or call 1-855-454-3887.

PI0002 R8

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics of avatrombopag were determined following administration of DOPTELET tablets, and pharmacokinetic parameters are presented as geometric mean (CV%) unless otherwise specified. Avatrombopag demonstrated dose-proportional pharmacokinetics after single doses from 10 mg (0.5 times the lowest approved dosage) to 80 mg (1.3 times the highest recommended dosage). Healthy subjects administered 40 mg of avatrombopag had a geometric mean (%CV) maximal concentration (C max ) of 166 (84%) ng/mL and area under the time-concentration curve extrapolated to infinity (AUC 0-inf ) of 4198 (83%) ng.hr/mL.

The pharmacokinetics of avatrombopag were similar in both healthy subjects and the chronic liver disease population. The relative bioavailability of DOPTELET SPRINKLE compared to DOPTELET tablet has not been studied. However, a prototype of DOPTELET SPRINKLE demonstrated a 22% higher geometric mean C max and a 38% higher geometric mean AUC for avatrombopag compared to DOPTELET tablet, both administered to healthy adult subjects under the fed condition.

Table 11 summarizes avatrombopag exposure in a virtual adult population and in pediatric patients with persistent or chronic immune thrombocytopenia. Table 11: Summary of Avatrombopag Exposure in a Virtual Adult Population and Pediatric Patients with Persistent or Chronic Immune Thrombocytopenia Cohort Adults 20 mg daily DOPTELET tablet ≥12 to <18 years N=21 20 mg daily DOPTELET tablet ≥6 to <12 years N=20 20 mg daily DOPTELET tablet ≥1 to <6 years N=12 10 mg daily DOPTELET SPRINKLE C max,ss (ng/mL) Geometric mean (CV) 165 (61.3) 168 (36.7) 267 (25.7) 221 (35.6) AUC ss (ng × h/mL) Geometric mean (CV) 3277 (62.2) 3372 (41.5) 4942 (28.7) 4030 (38.6) AUC ss = area under the concentration time curve at steady-state; C max,ss = maximal concentration at steady-state; CV = coefficient of variation expressed as a percent; N = number of individuals.

Absorption The median time to maximal concentration (T max ) occurred at 5 to 6 hours post-dose. Effect of Food Avatrombopag AUC 0-inf and C max were not affected when DOPTELET tablets were co-administered with a low-fat meal (500 calories, 3 g fat, 15 g protein, and 108 g carbohydrates) or a high-fat meal (918 calories, 59 g fat, 39 g protein, and 59 g carbohydrates). The variability of avatrombopag exposure was reduced by 40% to 60% with food.

The T max of avatrombopag was delayed by 0 to 2 hours when DOPTELET tablets were administered with a low-fat or high-fat meal (median T max range 5 to 8 hours) compared to the fasted state. Geometric mean exposure increased by approximately 19% and 32% for C max and AUC, respectively, when a prototype of DOPTELET SPRINKLE was administered in the fed state compared to the fasted state, and between-subject variability estimates for AUC and C max were decreased after administration in the fed state. Distribution Avatrombopag has an estimated mean apparent volume of distribution (%CV) of 180 L (25%).

Avatrombopag is greater than 96% bound to human plasma proteins. Elimination The mean plasma elimination half-life (%CV) of avatrombopag is approximately 19 hours (19%). The mean (%CV) of the apparent clearance of avatrombopag is estimated to be

6.9L/hr (29%). Metabolism Avatrombopag is primarily metabolized by cytochrome P450 CYP2C9 and CYP3A4. Excretion Fecal excretion accounted for 88% of the administered dose, with 34% of the dose excreted as unchanged avatrombopag.

Only 6% of the administered dose was found in urine. Specific Populations Age (1-86 years), sex, race [Whites, African-Americans, and East Asians (i.e., Japanese, Chinese and Koreans)], and any hepatic impairment (Child-Turcotte-Pugh (CTP) grade A, B, and C, or Model for End-Stage Liver Disease (MELD) score 4-23) and mild to moderate renal impairment (CLcr ≥30 mL/min) did not have clinically meaningful effects on the pharmacokinetics of avatrombopag. Lower body weight was associated with higher avatrombopag C max and A… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 118 words ▾

12.2Pharmacodynamics Platelet Response DOPTELET tablet administered to adult patients resulted in dose- and exposure-dependent elevations in platelet counts. The onset of the platelet count increase was observed within 3 to 5 days of the start of treatment, with peak effect after 10 to 13 days. Post treatment, platelet counts decreased gradually, returning to near baseline values.

Cardiac Electrophysiology At exposures similar to that achieved at the 40 mg and 60 mg tablet dose, DOPTELET did not prolong the QT interval to any clinically relevant extent. Mean QTc prolongation effects >20 ms are not anticipated with the highest recommended therapeutic dosing regimen based on analysis of data from the pooled clinical trials in patients with chronic liver disease.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Patients with Chronic Liver Disease The efficacy of DOPTELET for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure was established in 2 identically-designed multicenter, randomized, double-blind, placebo-controlled trials (ADAPT-1 [ NCT01972529 ] and ADAPT-2 [ NCT01976104 ]). In each trial, patients were assigned to the Low Baseline Platelet Count Cohort (<40×10] and ADAPT-2 [ NCT01976104 ]). In each trial, patients were assigned to the Low Baseline Platelet Count Cohort (<40×10 9 /L) or the High Baseline Platelet Count Cohort (≥40 to <50×10 9 /L) based on their platelet count at baseline.

Patients were then randomized in a 2:1 ratio to either DOPTELET or placebo. Patients were stratified according to hepatocellular cancer (HCC) status and risk of bleeding associated with the elective procedure (low, moderate, or high). Patients undergoing neurosurgical interventions, thoracotomy, laparotomy or organ resection were not eligible for enrollment.

Patients in the Low Baseline Platelet Count Cohort received 60 mg DOPTELET or matching placebo once daily for 5 days, and patients in the High Baseline Platelet Count Cohort received 40 mg DOPTELET or matching placebo once daily for 5 days. Eligible patients were scheduled to undergo their procedure (low, moderate, or high bleeding risk) 5 to 8 days after their last dose of treatment. Patient populations were similar between the pooled Low and High Baseline Platelet Count Cohorts and consisted of 66% male and 35% female; median age 58 years and 61% White, 34% Asian, and 3% Black.

In ADAPT-1, a total of 231 patients were randomized, 149 patients were treated with DOPTELET and 82 patients were treated with placebo. In the Low Baseline Platelet Count Cohort, the mean baseline platelet count for the DOPTELET-treated group was 31.1×10 9 /L and for the placebo-treated patients was 30.7×10 9 /L. In the High Baseline Platelet Count Cohort, the mean baseline platelet count for the DOPTELET-treated patients was 44.3×10 9 /L and for placebo-treated patients was 44.9×10 9 /L.

In ADAPT-2, a total of 204 patients were randomized, 128 patients were treated with DOPTELET and 76 patients were treated with placebo. In the Low Baseline Platelet Count Cohort, the mean baseline platelet count for the DOPTELET-treated group was 32.7×10 9 /L and for the placebo-treated patients was 32.5×10 9 /L. In the High Baseline Platelet Count Cohort, the mean baseline platelet count for the DOPTELET-treated patients was 44.3×10 9 /L and for the placebo-treated patients was 44.5×10 9 /L.

Across both baseline platelet count cohorts and the avatrombopag and placebo treatment groups, patients underwent a broad spectrum of types of scheduled procedures that ranged from low to high bleeding risk. Overall, the majority of patients (60.8% [248/430] subjects) in all treatment groups underwent low bleeding risk procedures, 17.2% (70/430) of patients underwent procedures associated with moderate bleeding risk, and 22.1% (90/430) of subjects underwent procedures associated with high bleeding risk. The proportions of patients undergoing low, moderate, and high-risk procedures were similar between the avatrombopag and placebo treatment groups.

The major efficacy outcome was the proportion of patients who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following an elective procedure. Additional secondary efficacy outcomes were the proportion of patients who achieved platelet counts of >50×10 9 /L on the day of procedure, and the change in platelet count from baseline to procedure day. Responders were defined as patients who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure.

The following were considered rescue therapies to manage the risk of bleeding associated with a procedure: whole blood… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 190 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In two-year carcinogenicity studies, avatrombopag was administered orally at doses of 20, 60, and 160 mg/kg/day in mice and doses of 20, 50, and 160 mg/kg/day in rats. Avatrombopag induced a statistically significant increase in neuroendocrine cell (enterochromaffin-like cell, ECL cell) gastric tumors (carcinoids) in the stomach at 160 mg/kg in female rats. The 160 mg/kg/day dose resulted in exposures 117 times the AUC observed in patients at the maximum recommended dose of 60 mg once daily.

The gastric carcinoids were considered likely due to prolonged hypergastrinemia observed in toxicity studies. Hypergastrinemia-related gastric carcinoids in rodents are generally considered to be of low risk or relevance to humans. Avatrombopag was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay or clastogenic in an in vitro human lymphocyte chromosomal aberrations assay or in an in vivo rat bone marrow micronucleus assay.

Avatrombopag did not affect fertility or early embryonic development in male rats at exposures 22 times, or in female rats at exposures 114 times, the AUC observed in patients at the maximum recommended dose of 60 mg once daily.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 187 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In two-year carcinogenicity studies, avatrombopag was administered orally at doses of 20, 60, and 160 mg/kg/day in mice and doses of 20, 50, and 160 mg/kg/day in rats. Avatrombopag induced a statistically significant increase in neuroendocrine cell (enterochromaffin-like cell, ECL cell) gastric tumors (carcinoids) in the stomach at 160 mg/kg in female rats. The 160 mg/kg/day dose resulted in exposures 117 times the AUC observed in patients at the maximum recommended dose of 60 mg once daily.

The gastric carcinoids were considered likely due to prolonged hypergastrinemia observed in toxicity studies. Hypergastrinemia-related gastric carcinoids in rodents are generally considered to be of low risk or relevance to humans. Avatrombopag was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay or clastogenic in an in vitro human lymphocyte chromosomal aberrations assay or in an in vivo rat bone marrow micronucleus assay.

Avatrombopag did not affect fertility or early embryonic development in male rats at exposures 22 times, or in female rats at exposures 114 times, the AUC observed in patients at the maximum recommended dose of 60 mg once daily.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION DOPTELET® (dop-TEL-et) (avatrombopag) tablets, for oral use DOPTELET® SPRINKLE (dop-TEL-et SPRINK-el) (avatrombopag) oral granules What are DOPTELET and DOPTELET SPRINKLE? DOPTELET is a prescription medicine used to treat low blood platelet counts in: adults with long-lasting (chronic) liver disease (CLD) who are scheduled to have a medical or dental procedure. adults with chronic immune thrombocytopenia (ITP) when other treatments have not worked well enough. children 1 year and older with persistent or chronic ITP when other treatments have not worked well enough.

DOPTELET tablets and DOPTELET SPRINKLE are different dosage forms of DOPTELET. DOPTELET SPRINKLE is a capsule that contains granules that are mixed with a soft food or liquid for dosing. DOPTELET tablets and DOPTELET SPRINKLE are not used to make platelet counts normal.

It is not known if DOPTELET tablets or DOPTELET SPRINKLE are safe and effective in children younger than 1 year of age. Before you take DOPTELET or DOPTELET SPRINKLE, tell your healthcare provider about all of your medical conditions, including if you: have ever had a blood clot. are pregnant or plan to become pregnant. DOPTELET may harm your unborn baby.

Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with DOPTELET. are breastfeeding or plan to breastfeed. It is not known if DOPTELET passes into your breast milk. Do not breastfeed during your treatment with DOPTELET and for at least 2 weeks after the last dose.

Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. DOPTELET or DOPTELET SPRINKLE may affect the way other medicines work, and other medicines may affect the way DOPTELET or DOPTELET SPRINKLE works.

How should I take DOPTELET? DOPTELET tablets that come in a blister package are not the same dosage form as DOPTELET SPRINKLE that come in a bottle and cannot be directly substituted for each other. Contact your or your child’s pharmacist or healthcare provider if you did not receive the correct dosage form.

Take DOPTELET exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much DOPTELET to take and when to start taking it. Your healthcare provider may change your dose of DOPTELET depending on your blood platelet counts.

Take DOPTELET with food. If you take DOPTELET to treat your low blood platelet counts due to chronic liver disease before a medical or dental procedure, your healthcare provider will check your platelet count before treatment and on the day of your scheduled procedure. If you take DOPTELET to treat your low blood platelet counts due to persistent or chronic immune thrombocytopenia, your healthcare provider will check your platelet count before, during and for at least 4 weeks after stopping your treatment with DOPTELET.

If you are taking DOPTELET before a scheduled medical procedure and you miss a dose, contact your healthcare provider for further dosing instructions. If you are taking DOPTELET for persistent or chronic immune thrombocytopenia and you miss a dose, take it as soon as you remember. Do not take 2 doses at one time to make up for a missed dose.

Take your next dose at your usual scheduled time. If you take too much DOPTELET, call your healthcare provider or Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away. How should I give DOPTELET SPRINKLE?

DOPTELET SPRINKLE oral granules that come in a bottle are not the same dosage form as DOPTELET tablets that come in a blister card and cannot be directly substituted for each other. Contact your child’s pharmacist or healthcare provider if you did not receive the correct dosage form. If your child is prescribed DOPTELET SPRINKLE: See the Instructions for Use on how to prepare and gi… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE DOPTELET ® SPRINKLE (dop-TEL-et SPRINK-el) (avatrombopag) oral granules Read these Instructions for Use to prepare and give a dose of DOPTELET SPRINKLE correctly . Important information that you need to know before giving DOPTELET SPRINKLE: The contents of DOPTELET SPRINKLE should be sprinkled onto a soft food or liquid, as described below. DOPTELET SPRINKLE that comes in a bottle is not the same dosage form as DOPTELET tablets that come in a blister card and these products cannot be directly substituted for each other.

Contact your child’s pharmacist or healthcare provider if your child did not receive the correct dosage form. DOPTELET SPRINKLE contains granules inside of a capsule. The capsule must be opened, and the granules inside must be sprinkled onto a soft food or liquid to give a dose of DOPTELET SPRINKLE.

Do not swallow the capsule whole or the empty capsule shells. Do not chew or crush the granules. Use all of the granules in the capsule.

Do not use part of a capsule to try to prepare a dose. Steps to prepare and give a dose of DOPTELET SPRINKLE: Gather supplies to prepare a dose of DOPTELET SPRINKLE: capsule(s), liquid or soft food, cup or spoon, and mixing utensil (e.g., stir stick or small spoon); then wash your hands. Put a small amount of soft food or liquid in a cup or spoon.

The following soft foods and liquids can be used: Soft foods applesauce strawberry jelly yogurt (plain) Liquids milk (whole or skim) orange juice pediatric electrolyte solution (unflavored) water 3. Carefully open the capsule (or 2 capsules if prescribed) by pulling it apart. Sprinkle the entire contents of the capsule onto the soft food or liquid that you put in the spoon or cup.

Make sure that all of the granules from the capsule have been completely emptied. 4. Mix or stir the granules into the soft food or liquid.

The granules will not dissolve. 5. Give the mixture right away; do not save for later use .

6. Rinse the spoon or cup with additional soft food or liquid to make sure that the entire dose is given. 7.

Throw the empty capsule shells away in the trash. How should I store DOPTELET SPRINKLE? Store DOPTELET SPRINKLE at room temperature from 68°F to 77°F (20°C to 25°C).

Keep DOPTELET SPRINKLE and all medicines out of the reach of children. DOPTELET is a registered trademark of AkaRx, Inc. Manufactured for AkaRx, Inc., Morrisville, North Carolina 27560 For more information, go to www.DOPTELET.com or call 1-855-454-3887.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 07/2025 PI0003 R1

📄 Recent Major Changes 36 words ▾

RECENT MAJOR CHANGES Indications and Usage ( 1.3 ) 07/2025 Dosage and Administration ( 2.1 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) 07/2025 Warnings and Precautions ( 5.1 ) 07/2024

📄 Package Label / Principal Display Panel 83 words ▾

PRINCIPAL DISPLAY PANEL NDC 71369-020-10 20 mg per tablet Rx Only Doptelet one blister card with 10 tablets image description

PRINCIPAL DISPLAY PANEL NDC 71369-020-15 20 mg per tablet Rx Only Doptelet one blister card with 15 tablets image description

PRINCIPAL DISPLAY PANEL NDC 71369-020-30 20 mg per tablet Rx Only Doptelet Two blister cards with 15 tablets each (30 tablets) image description

PRINCIPAL DISPLAY PANEL NDC 71369-010-30 10 mg per capsule Rx Only Doptelet Sprinkle one bottle with 30 capsules image description

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q4 2025 – Q1 2026 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
14
Units reimbursed last 4 qtrs
516
Gross reimbursed last 4 qtrs
$224.9K
Avg / prescription
$16,062.20
Avg / unit
$435.80
Latest quarter Q1 2026
14Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 14 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 516 units · 1.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.31.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 1.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 Doptelet Sprinkle (this brand).

Top reported reactions

Platelet Count Decreased31
Immune Thrombocytopenia22
Thrombocytopenia19
Death16
Infection16
Diarrhoea15
Abdominal Pain14

Age at onset

Child2
Adolescent2
Adult66
Elderly24

Reporter sex

355 reports
Male · 39%
Female · 61%

Serious outcomes

Hospitalization134
Death44
Life-threatening23
Disabling5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 102 1
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) ✓ Available
“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 AkaRx, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AkaRx, 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.
← 71363-0107-30 · Zag 71369-0020-10 · AkaRx, →
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.