Home › NDC Lookup › Ingredients › Fosaprepitant Dimeglumine › 00143-9384-01
💉image loading
(from DailyMed)

FOSAPREPITANT DIMEGLUMINE 150 mg/5mL Injection, Powder, Lyophilized, For Solution — NDC 0143-9384-01 (Billing 00143-9384-01)

by Hikma Pharmaceuticals USA Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE

This is a package of FOSAPREPITANT DIMEGLUMINE 150 mg/5mL Injection, Powder, Lyophilized, For Solution from Hikma Pharmaceuticals USA Inc., marketed since Sep 2020 and currently FDA-listed. It is this product's only package size.

NDC 00143-9384-01
🏷️ FDA NDC (as labeled) 0143-9384-01 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0143-9384-01
Product NDC 0143-9384
11-digit billing NDC 00143938401
NCPDP billing unit EA — each (per item)
RxCUI 1731077
UNII D35FM8T64X
Application # ANDA213106
SPL Set ID 1cc7d482-5d45-4621-9ffc-cd3f7c54614d
Established class (EPC) Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of action Cytochrome P450 2C9 Inducers; Cytochrome P450 3A4 Inducers; Cytochrome P450 3A4 Inhibitors; Neurokinin 1 Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-08
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance FOSAPREPITANT DIMEGLUMINE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 50280035102130
GPI class Fosaprepitant Dimeglumine
GCN Seq No 066837
GCN 29247
HICL code 035346
Ingredient (HICL) Fosaprepitant Dimeglumine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 56:22.32.00
AHFS class Neurokinin-1 Receptor Antagonists
FDB label name FOSAPREPITANT 150 MG VIAL
FDB brand name Fosaprepitant Dimeglumine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066837
  • GCN: 29247
  • GPI-14 (Medi-Span): 50280035102130
  • HICL (First Databank): 035346
  • AHFS class code: 56:22.32.00
  • RxCUI (RxNorm): 1731077
Why two NDCs? The FDA registers this code as 0143-9384-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00143-9384-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name FOSAPREPITANT 150 MG VIAL Ingredient Fosaprepitant Dimeglumine
📗 Our plain-language guide HelloPharmacist
  • It helps prevent nausea and vomiting caused by cancer chemotherapy. You get it along with other anti-nausea medicines. It prevents symptoms but is not studied for treating nausea t...
  • A healthcare professional gives it as an IV infusion, usually on the first day of chemotherapy. It finishes about 30 minutes before chemo begins. You will also get a steroid and an...
  • Fatigue, diarrhea, low blood counts and weakness are common. Some people have pain or redness at the IV site. Tell your team about any discomfort at the site.
  • Tell your nurse immediately if you feel flushed, short of breath, faint or have a rash during or after the infusion. Also report severe pain or swelling where the IV is.
📖 Read our full Fosaprepitant Dimeglumine 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 $105.89 $529.44 / 5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1453 $0.123 / J1453 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0143-9384-01
11-digit billing NDC00143-9384-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1453
DescriptorINJECTION, FOSAPREPITANT, 1 MG
Billing units / pkg150 units
How the units are derivedThis package is 1 EA; the HCPCS unit is 1 MG, so one package = 150 billing units.
Medicare Part B spend (2026 (Q1))$297,287 · 19,071 claims · $15.59 per claim (all NDCs under J1453)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00143-9384-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE 2020-09-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Emend 150 mg/5mL 00006-3061-00 Merck 1 vial — AP FDA listed —
Fosaprepitant Dimeglumine 150 mg/5mLthis 00143-9384-01 Hikma 1 vial — AP FDA listed —
Fosaprepitant Dimeglumine 150 mg/5mL 00143-9428-01 Hikma 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 00338-0008-01 Baxter 1 vial — — FDA listed —
Fosaprepitant 150 mg 00591-4385-79 Actavis 1 injection — — FDA listed —
Fosaprepitant 150 mg/5mL 16714-0248-01 NorthStar 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 31722-0165-31 Camber 1 vial — AP FDA listed —
Fosaprepitant 150 mg 43598-0671-11 Dr. 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 43598-0859-11 Dr. 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 43598-0948-11 Dr. 1 vial — AP FDA listed —
Fosaprepitant Dimeglumine 150 mg/5mL 55150-0299-01 Eugia 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 63323-0972-10 Fresenius 1 vial — AP FDA listed —
Fosaprepitant Dimeglumine 150 mg/5mL 67184-0540-01 Qilu 1 vial — AP FDA listed —
fosaprepitant 150 mg/5mL 67457-0889-10 Mylan 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 68001-0523-36 BluePoint 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 68001-0675-25 BluePoint 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 71731-5111-01 Chia 1 vial — AP FDA listed —
fosaprepitant 150 mg/5mL 71839-0104-01 BE 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 72162-2636-02 Bryant 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 72205-0054-01 Novadoz 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 72205-0083-01 Novadoz 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 72603-0450-01 Northstar 1 vial — AP FDA listed —
Fosaprepitant 150 mg/5mL 83634-0776-10 Avenacy, 1 vial — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

  • 375 mg / 5 mL UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 5.4 mg / 5 mL UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 75 mg / 5 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.

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

LabelerHikma Pharmaceuticals USA Inc.
Application holderQILU PHARMACEUTICAL HAINAN CO LTD
FDA applicationANDA213106 (ANDA)
Labeler code00143
First marketedSep 2020
Product typeHuman Prescription Drug
Portfolio726 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 179 words ▾

1 INDICATIONS AND USAGE Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use Fosaprepitant for Injection has not been studied for the treatment of established nausea and vomiting.

Fosaprepitant for Injection is a substance P/neurokinin-1 (NK 1 ) receptor antagonist, indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, for the prevention of ( 1 ): acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use ( 1 ) Fosaprepitant for Injection has not been studied for treatment of established nausea and vomiting.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Re c o mm ended Adult Do s age ( 2 .1 ) Fosaprepitant for injection 150 mg on Day 1 as an intravenous infusion over 20 to 30 minutes. ( 2.1 ) Complete the infusion approximately 30 minutes prior to chemotherapy. Recommended Dosage for Pediatric Patients (6 months to 17 years) Weighing at Least 6 kg ( 2.2 ) See Full Prescribing Information for pediatric dosage regimens by age.

For single dose chemotherapy regimens : single dose of fosaprepitant for injection on Day 1. For single or multi-day chemotherapy regimens : 3-day fosaprepitant/aprepitant regimen of fosaprepitant for injection on Days 1,2, and 3. Aprepitant capsules or aprepitant for oral suspension may be used as an alternative on Days 2 and 3.

Administer fosaprepitant for injection through a central venous catheter as an intravenous infusion over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years). Complete the infusion approximately 30 minutes prior to chemotherapy. Concomitant Antiemetics See Full Prescribing Information for additional information.

( 2.1 , 2.2 )

2.1Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients The recommended dosage of fosaprepitant for injection, dexamethasone, and a 5-HT 3 antagonist for the prevention of nausea and vomiting associated with administration of HEC or MEC in adults is shown in Table 1 or Table 2, respectively. Administer fosaprepitant for injection as an intravenous infusion on Day 1 over 20 to 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy. Table 1 Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with HEC Day 1 Day 2 Day 3 Day 4 Fosaprepitant for Injection 150 mg intravenously over 20 to 30 minutes none none none Dexamethasone Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4.

Also administer dexamethasone in the evenings on Days 3 and 4. A 50% dosage reduction of dexamethasone on Days 1 and 2 is recommended to account for a drug interaction with fosaprepitant for injection [see Clinical Pharmacology (12.3) ] . 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily 5-HT 3 antagonist See selected 5-HT 3 antagonist prescribing information for the recommended dosage none none none Table 2 Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with MEC Day 1 Fosaprepitant for Injection 150 mg intravenously over 20 to 30 minutes Dexamethasone Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1.

A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with fosaprepitant for injection [see Clinical Pharmacology (12.3) ] . 12 mg orally 5-HT 3 antagonist See selected 5-HT 3 antagonist prescribing information for the recommended dosage

2.2Prevention of Nausea and Vomiting Associated with HEC and MEC in Pediatric Patients The recommended pediatric dosage regimens of fosaprepitant/aprepitant for injection, to be administered with a 5-HT 3 antagonist, with or without a corticosteroid, for the prevention of nausea and vomiting associated with administration of single or multi-day chemotherapy regimens of HEC or MEC, are shown in Tables 3 and 4. Single-day chemotherapy regimens include regimens in which HEC or MEC is administered for a single day only.

Multi-day chemotherapy regimens include chemotherapy regimens in which HEC or MEC is administered for 2 or more days. Fosaprepitant/Aprepitant for Injection Dosage Regimens for Use with Single-Day Chemotherapy Regimens For pediatric patients weighing at least 6 kg receiving single-day HEC or MEC, fosaprepitant/aprepitant may be administered as: a single dose regimen of fosaprepitant for injection infused through a central venous catheter on Day 1, as shown in Table 3; or as a 3-day fosaprepitant/aprepitant regimen consisting of fosaprepitant for injection as an intravenous infusion th… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Fosaprepitant for Injection: 150 mg fosaprepitant, white to off-white lyophilized powder in single-dose glass vial for reconstitution Fosaprepitant for Injection: 150 mg fosaprepitant, lyophilized powder in single-dose vial for reconstitution. ( 3 )

⛔ Contraindications 107 words ▾

4 CONTRAINDICATIONS Fosaprepitant for Injection is contraindicated in patients: who are hypersensitive to any component of the product. Hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [see Warnings and Precautions (5.2) , Adverse Reactions (6.2) ] . taking pimozide. Inhibition of CYP3A4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide [see Warnings and Precautions (5.1) ].

Known hypersensitivity to any component of this drug. ( 4 , 5.2 ) Concurrent use with pimozide. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS CYP3A4 Interactions: Fosaprepitant is a weak inhibitor of CYP3A4, and aprepitant, the active moiety, is a substrate, inhibitor, and inducer of CYP3A4; see Full Prescribing Information for recommendations regarding contraindications, risk of adverse reactions, and dosage adjustment of fosaprepitant for injection and concomitant drugs. ( 4 , 5.1 , 7.1 , 7.2 ) Hypersensitivity Reactions (including anaphylaxis and anaphylactic shock): May occur during or soon after infusion. If symptoms occur, discontinue the drug.

Do not reinitiate fosaprepitant for injection if symptoms occur with previous use. ( 4 , 5.2 ) Infusion Site Reactions (including thrombophlebitis, necrosis, and vasculitis): Majority of reactions reported in patients receiving vesicant chemotherapy. Avoid infusion into small veins.

Discontinue infusion and administer treatment if a severe reaction develops. ( 5.3 ) Warfarin (a CYP2C9 substrate): Risk of decreased INR of prothrombin time; monitor INR in 2–week period, particularly at 7 to 10 days, following initiation of fosaprepitant for injection. ( 5.4 , 7.1 ) Hormonal Contraceptives: Efficacy of contraceptives may be reduced during and for 28 days following administration of fosaprepitant for injection.

Use effective alternative or back-up methods of contraception. ( 5.5 , 7.1 , 8.3 )

5.1Clinically Significant CYP3A4 Drug Interactions Fosaprepitant, a prodrug of aprepitant, is a weak inhibitor of CYP3A4, and aprepitant is a substrate, inhibitor, and inducer of CYP3A4. Use of fosaprepitant for injection with other drugs that are CYP3A4 substrates, may result in increased plasma concentration of the concomitant drug. Use of pimozide with fosaprepitant for injection is contraindicated due to the risk of significantly increased plasma concentrations of pimozide, potentially resulting in prolongation of the QT interval, a known adverse reaction of pimozide [see Contraindications (4) ].

Use of fosaprepitant for injection with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, diltiazem) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to fosaprepitant for injection. Use of fosaprepitant for injection with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of fosaprepitant for injection. See Table 7 and Table 8 for a listing of potentially significant drug interactions [see Drug Interactions (7.1 , 7.2) ].

5.2Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock, during or soon after infusion of fosaprepitant for injection have occurred. Symptoms including flushing, erythema, dyspnea, hypotension and syncope have been reported [see Adverse Reactions (6.2) ] . Monitor patients during and after infusion.

If hypersensitivity reactions occur, discontinue the infusion and administer appropriate medical therapy. Do not reinitiate fosaprepitant for injection in patients who experience these symptoms with previous use [see Contraindications (4) ] .

5.3Infusion Site Reactions Infusion site reactions (ISRs) have been reported with the use of fosaprepitant for injection [see Adverse Reactions (6.1) ] . The majority of severe ISRs, including thrombophlebitis and vasculitis, were reported with concomitant vesicant (anthracycline-based) chemotherapy administration, particularly when associated with extravasation. Necrosis was also reported in some patients with concomitant vesicant chemotherapy.

Most ISRs occurred with the first, second or third exposure to single doses of fosaprepitant for injection and in some cases, reactions persisted for two weeks or longer. Treatment of severe ISRs consisted of medical, and in some cases surgical, intervention. Avoid infusion of fosaprepitant for injection into small veins or through a butterfly catheter.

If a severe ISR develops during infusion, discontinue the infusion and… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Infusion Site Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions in adults (≥2%) are: fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity. ( 6.1 ) Adverse reactions in pediatrics are similar to adults. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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 clinical practice. The overall safety of fosaprepitant for injection was evaluated in approximately 1800 adult and pediatric patients. Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with MEC In an active-controlled clinical trial in patients receiving MEC, safety was evaluated in 504 patients receiving a single dose of fosaprepitant for injection in combination with ondansetron and dexamethasone (fosaprepitant for injection regimen) compared to 497 patients receiving ondansetron and dexamethasone alone (standard therapy).

The most common adverse reactions are listed in Table 6. Table 6 Most Common Adverse Reactions in Patients Receiving MEC Reported in ≥2% of patients treated with the fosaprepitant for injection regimen and at a greater incidence than standard therapy. Fosaprepitant for Injection, ondansetron, and dexamethasone Fosaprepitant for Injection regimen (N=504) Ondansetron and dexamethasone Standard therapy (N=497) fatigue 15% 13% diarrhea 13% 11% neutropenia 8% 7% asthenia 4% 3% anemia 3% 2% peripheral neuropathy 3% 2% leukopenia 2% 1% dyspepsia 2% 1% urinary tract infection 2% 1% pain in extremity 2% 1% Infusion-site reactions were reported in 2.2% of patients treated with the fosaprepitant for injection regimen compared to 0.6% of patients treated with standard therapy.

The infusion-site reactions included: infusion-site pain (1.2%, 0.4%), injection-site irritation (0.2%, 0.0%), vessel puncture-site pain (0.2%, 0.0%), and infusion-site thrombophlebitis (0.6%, 0.0%), reported in the fosaprepitant for injection regimen compared to standard therapy, respectively. Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with HEC In an active-controlled clinical study in patients receiving HEC, safety was evaluated for 1143 patients receiving a single dose of fosaprepitant for injection compared to 1169 patients receiving the 3-day regimen of oral aprepitant [see Clinical Studies (14.1) ] .

The safety profile was generally similar to that seen in the MEC study with fosaprepitant and prior HEC studies with aprepitant. However, infusion-site reactions occurred at a higher incidence in patients in the fosaprepitant group (3.0%) compared to those in the aprepitant group (0.5%). The following additional infusion-site reactions occurred in the HEC study and were not reported in the MEC study described above: infusion-site erythema (0.5%, 0.1%), infusion-site pruritus (0.3%, 0.0%), and infusion-site induration (0.2%, 0.1%), reported in the fosaprepitant group compared to the aprepitant group, respectively.

Adverse Reactions in Pediatric Patients 6 Months to 17 Years of Age for the Prevention of Nausea and Vomiting Associated with HEC or MEC Single-Dose Fosaprepitant for Injection Regimen The safety of a single dose of fosaprepitant for injection in pediatric patients (6 months to 17 years) was evaluated in two active-controlled and a single-arm clinical study in patients who received either HEC or MEC. Patients also received ondansetron with or without dexame… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See Full Prescribing Information for a list of clinically significant drug interactions. ( 4 , 5.1 , 5.4 , 5.5 , 7.1 , 7.2 )

7.1Effect of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs When administered intravenously, fosaprepitant, a prodrug of aprepitant, is converted to aprepitant within 30 minutes. Therefore, drug interactions following administration of fosaprepitant for injection are likely to occur with drugs that interact with oral aprepitant. Fosaprepitant, given as a single 150-mg dose, is a weak inhibitor of CYP3A4, and the weak inhibition of CYP3A4 continues for 2 days after single dose administration.

Single dose fosaprepitant does not induce CYP3A4. Aprepitant is a substrate, an inhibitor, and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9 [see Clinical Pharmacology (12.3) ] .

Some substrates of CYP3A4 are contraindicated with fosaprepitant for injection [see Contraindications (4) ] . Dosage adjustment of some CYP3A4 and CYP2C9 substrates may be warranted, as shown in Table 7. Table 7 Effects of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs CYP3A4 Substrates Pimozide Clinical Impact Increased pimozide exposure Intervention Fosaprepitant for Injection is contraindicated [see Contraindications (4) ].

Benzodiazepines Clinical Impact Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see Clinical Pharmacology (12.3) ]. Intervention Monitor for benzodiazepine-related adverse reactions. Dexamethasone Clinical Impact Increased dexamethasone exposure [see Clinical Pharmacology (12.3) ].

Intervention Reduce the dose of oral dexamethasone by approximately 50% [see Dosage and Administration (2.1) ]. Methylprednisolone Clinical Impact Increased methylprednisolone exposure [see Clinical Pharmacology (12.3) ]. Intervention Reduce the dose of oral methylprednisolone by approximately 50% on Days 1 and 2 for patients receiving HEC and on Day 1 for patients receiving MEC.

Reduce the dose of intravenous methylprednisolone by 25% on Days 1 and 2 for patients receiving HEC and on Day 1 for patients receiving MEC. Chemotherapeutic agents that are metabolized by CYP3A4 Clinical Impact Increased exposure of the chemotherapeutic agent may increase the risk of adverse reactions [see Clinical Pharmacology (12.3) ]. Intervention Vinblastine, vincristine, or ifosfamide or other chemotherapeutic agents Monitor for chemotherapeutic-related adverse reactions.

Etoposide, vinorelbine, paclitaxel, and docetaxel No dosage adjustment needed. Hormonal Contraceptives Clinical Impact Decreased hormonal exposure during administration of and for 28 days after administration of the last dose of fosaprepitant for injection [see Warnings and Precautions (5.5) , Use in Specific Populations (8.3) , and Clinical Pharmacology (12.3) ]. Intervention Effective alternative or back-up methods of contraception (such as condoms and spermicides) should be used during treatment with fosaprepitant for injection and for 1 month following administration of fosaprepitant for injection.

Examples birth control pills, skin patches, implants, and certain IUDs CYP2C9 Substrates Warfarin Clinical Impact Decreased warfarin exposure and decreased prothrombin time (INR) [see Warnings and Precautions (5.4) , Clinical Pharmacology (12.3) ]. Intervention In patients on chronic warfarin therapy, monitor the prothrombin time (INR) in the 2-week period, particularly at 7 to 10 days, following administration of fosaprepitant for injection with each chemotherapy cycle. Other 5-HT 3 Antagonists Clinical Impact No change in the exposure of the 5-HT 3 antagonist [see Clinical Pharmacology (12.3) ].

Intervention No dosage adjustment needed Examples ondansetron, granisetron, dolasetron

7.2Effect of Other Drugs on the Pharmacokinetics of Fosaprepitant/Aprepitant Aprepitant is a CYP3A4 substrate [see Clinical Pharmacology (12.3) ]… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are insufficient data on use of fosaprepitant for injection in pregnant women to inform a drug associated risk. In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (AUC) approximately equivalent to the exposure at the recommended human dose (RHD) of 150 mg [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 25 mg/kg/day (rabbits). No embryofetal lethality or malformations were observed at any dose level in either species.

The exposures (AUC) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 25 mg/kg/day were approximately equivalent to the exposure at the RHD of 150 mg. Aprepitant crosses the placenta in rats and rabbits.

8.2Lactation Risk Summary Lactation studies have not been conducted to assess the presence of aprepitant in human milk, the effects on the breastfed infant, or the effects on milk production. Aprepitant is present in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fosaprepitant for injection and any potential adverse effects on the breastfed infant from fosaprepitant for injection or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Contraception Upon administration of fosaprepitant for injection, the efficacy of hormonal contraceptives may be reduced. Advise females of reproductive potential using hormonal contraceptives to use an effective alternative or back-up non-hormonal contraceptive (such as condoms and spermicides) during treatment with fosaprepitant for injection and for 1 month following the last dose [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] .

8.4Pediatric Use The safety and effectiveness of a single dose and a 3-day regimen of fosaprepitant for injection have been established in pediatric patients 6 months to 17 years for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC and MEC. Use of fosaprepitant for injection in this age group is supported by evidence from adequate and well-controlled studies of fosaprepitant for injection in adults, with additional safety, efficacy and pharmacokinetic data in pediatric patients 6 months to 17 years.

Efficacy and safety were also supported by data from an adequate and well-controlled study of a 3-day oral aprepitant regimen in pediatric patients 6 months to 17 years. The safety of the 3-day fosaprepitant for injection regimen in pediatric patients 6 months to 17 years of age was supported by an open-label study in 100 patients receiving HEC or MEC. See the full prescribing information for aprepitant capsules for complete clinical information regarding studies performed with oral aprepitant.

Adverse reactions were similar to those reported in adult patients [See Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) ]. The safety and effectiveness of fosaprepitant for injection for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months of age. Juvenile Animal Toxicity Data In juvenile dogs treated with fosaprepitant, changes in reproductive organs were observed.

In juvenile rats treated with aprepitant, slight changes in sexual maturation were observed without an effect on reproduction. No effects on neurobe… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 202 words ▾

8.1Pregnancy Risk Summary There are insufficient data on use of fosaprepitant for injection in pregnant women to inform a drug associated risk. In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (AUC) approximately equivalent to the exposure at the recommended human dose (RHD) of 150 mg [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In embryofetal development studies in rats and rabbits, aprepitant was administered during the period of organogenesis at oral doses up to 1000 mg/kg twice daily (rats) and up to the maximum tolerated dose of 25 mg/kg/day (rabbits). No embryofetal lethality or malformations were observed at any dose level in either species.

The exposures (AUC) in pregnant rats at 1000 mg/kg twice daily and in pregnant rabbits at 25 mg/kg/day were approximately equivalent to the exposure at the RHD of 150 mg. Aprepitant crosses the placenta in rats and rabbits.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of a single dose and a 3-day regimen of fosaprepitant for injection have been established in pediatric patients 6 months to 17 years for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC and MEC. Use of fosaprepitant for injection in this age group is supported by evidence from adequate and well-controlled studies of fosaprepitant for injection in adults, with additional safety, efficacy and pharmacokinetic data in pediatric patients 6 months to 17 years.

Efficacy and safety were also supported by data from an adequate and well-controlled study of a 3-day oral aprepitant regimen in pediatric patients 6 months to 17 years. The safety of the 3-day fosaprepitant for injection regimen in pediatric patients 6 months to 17 years of age was supported by an open-label study in 100 patients receiving HEC or MEC. See the full prescribing information for aprepitant capsules for complete clinical information regarding studies performed with oral aprepitant.

Adverse reactions were similar to those reported in adult patients [See Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) ]. The safety and effectiveness of fosaprepitant for injection for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months of age. Juvenile Animal Toxicity Data In juvenile dogs treated with fosaprepitant, changes in reproductive organs were observed.

In juvenile rats treated with aprepitant, slight changes in sexual maturation were observed without an effect on reproduction. No effects on neurobehavior, sensory and motor function, or learning and memory were observed in rats. In a toxicity study in juvenile dogs treated with fosaprepitant from postnatal day 14 (equivalent to a newborn human) to day 42 (approximately equivalent to a 2 year old human), decreased testicular weight and Leydig cell size were seen in the males at 6 mg/kg/day and increased uterine weight, hypertrophy of the uterus and cervix, and edema of vaginal tissues were seen in females from 4 mg/kg/day.

A study was also conducted in young rats to evaluate the effects of aprepitant on growth and on neurobehavioral and sexual development. Rats were treated at oral doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male and female rats lower than the exposure at the recommended pediatric human dose) from the early postnatal period (Postnatal Day 10 (equivalent to a newborn human) through Postnatal Day 58 (approximately equivalent to a 15 year old human)). Slight changes in the onset of sexual maturation were observed in female and male rats; however, there were no effects on mating, fertility, embryonic-fetal survival, or histomorphology of the reproductive organs.

There were no effects in neurobehavioral tests of sensory function, motor function, and learning and memory.

🧓 Geriatric Use 87 words ▾

8.5Geriatric Use Of the 1649 adult cancer patients treated with intravenous fosaprepitant for injection in HEC and MEC clinical studies, 27% were aged 65 and over, while 5% were aged 75 and over. Other reported clinical experience with fosaprepitant for injection has not identified differences in responses between elderly and younger patients. In general, use caution when dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy [see Clinical Pharmacology (12.3) ] .

🆘 Overdosage 64 words ▾

10 OVERDOSAGE There is no specific information on the treatment of overdosage with fosaprepitant or aprepitant. In the event of overdose, fosaprepitant for injection should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of fosaprepitant for injection, drug-induced emesis may not be effective in cases of fosaprepitant for injection overdosage. Aprepitant is not removed by hemodialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fosaprepitant is a prodrug of aprepitant and accordingly, its antiemetic effects are attributable to aprepitant. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK 1 ) receptors. Aprepitant has little or no affinity for serotonin (5-HT 3 ), dopamine, and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting (CINV).

Aprepitant has been shown in animal models to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin, via central actions. Animal and human Positron Emission Tomography (PET) studies with aprepitant have shown that it crosses the blood brain barrier and occupies brain NK 1 receptors. Animal and human studies have shown that aprepitant augments the antiemetic activity of the 5-HT 3 -receptor antagonist ondansetron and the corticosteroid dexamethasone and inhibits both the acute and delayed phases of cisplatin-induced emesis.

12.2Pharmacodynamics Cardiac Electrophysiology In a randomized, double-blind, positive-controlled, thorough QTc study, a single 200-mg dose of fosaprepitant (approximately 1.3 times the recommended dose) had no effect on the QTc interval.

12.3Pharmacokinetics Aprepitant after Fosaprepitant Administration Following administration of a single intravenous 150-mg dose of fosaprepitant, a prodrug of aprepitant administered as a 20-minute infusion to healthy subjects, the mean AUC 0-∞ of aprepitant was 37.4 (± 14.8) mcg∙hr/mL and the mean maximal aprepitant concentration (C max ) was 4.2 (± 1.2) mcg/mL. Plasma concentrations of fosaprepitant are below the limits of quantification (10 ng/mL) within 30 minutes of the completion of infusion. Distribution Aprepitant is greater than 95% bound to plasma proteins.

The mean apparent volume of distribution at steady state (Vd ss ) was approximately 70 L in humans. Aprepitant crosses the blood brain barrier in humans [see Clinical Pharmacology (12.1) ] . Elimination Metabolism Fosaprepitant is converted to aprepitant in in vitro incubations with human liver preparations and in S9 preparations from multiple other human tissues including kidney, lung and ileum.

Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple extrahepatic tissues in addition to the liver. Aprepitant undergoes extensive metabolism. In vitro studies using human liver microsomes indicate that aprepitant is metabolized primarily by CYP3A4 with minor metabolism by CYP1A2 and CYP2C19.

Metabolism is largely via oxidation at the morpholine ring and its side chains. No metabolism by CYP2D6, CYP2C9, or CYP2E1 was detected. In healthy young adults, aprepitant accounts for approximately 24% of the radioactivity in plasma over 72 hours following a single oral 300-mg dose of [ 14 C]-aprepitant, indicating a substantial presence of metabolites in the plasma.

Seven metabolites of aprepitant, which are only weakly active, have been identified in human plasma. Excretion Following administration of a single intravenous 100-mg dose of [ 14 C]-fosaprepitant to healthy subjects, 57% of the radioactivity was recovered in urine and 45% in feces. Aprepitant is eliminated primarily by metabolism; aprepitant is not renally excreted.

The apparent terminal half-life ranged from approximately 9 to 13 hours. Specific Populations Age: Geriatric Population Following oral administration of a single 125-mg dose of aprepitant on Day 1 and 80 mg once daily on Days 2 through 5, the AUC 0-24hr of aprepitant was 21% higher on Day 1 and 36% higher on Day 5 in elderly (65 years and older) relative to younger adults. The C max was 10% higher on Day 1 and 24% higher on Day 5 in elderly relative to younger adults.

These differences are not considered clinically meaningful [see Use in Specific Populations (8.5) ] . Age: Pediatric Population Single-Dose Fosaprepitant for Injection Regimen: Simulated systemic exposures of aprepitant in patien… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 140 words ▾

12.1Mechanism of Action Fosaprepitant is a prodrug of aprepitant and accordingly, its antiemetic effects are attributable to aprepitant. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK 1 ) receptors. Aprepitant has little or no affinity for serotonin (5-HT 3 ), dopamine, and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting (CINV).

Aprepitant has been shown in animal models to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin, via central actions. Animal and human Positron Emission Tomography (PET) studies with aprepitant have shown that it crosses the blood brain barrier and occupies brain NK 1 receptors. Animal and human studies have shown that aprepitant augments the antiemetic activity of the 5-HT 3 -receptor antagonist ondansetron and the corticosteroid dexamethasone and inhibits both the acute and delayed phases of cisplatin-induced emesis.

📦 How Supplied / Storage and Handling 69 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Single-dose glass vial containing 150 mg of fosaprepitant as a white to off-white lyophilized powder for reconstitution. Supplied as follows: NDC 0143-9384-01 1 vial per carton. Storage Fosaprepitant for Injection vials must be refrigerated, store at 2°C to 8°C (36°F to 46°F). The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)]. Discard unused portion.

📦 Storage and Handling 38 words ▾

Storage Fosaprepitant for Injection vials must be refrigerated, store at 2°C to 8°C (36°F to 46°F). The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)]. Discard unused portion.

📋 Description 142 words ▾

11 DESCRIPTION Fosaprepitant for Injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK 1 ) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2 R ,3 S )-2-[(1 R )-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1 H -1,2,4-triazol-1-yl]phosphonate (2:1) (salt). Its empirical formula is C 23 H 22 F 7 N 4 O 6 P ∙ 2(C 7 H 17 NO 5 ) and its structural formula is: Fosaprepitant dimeglumine is a white or off-white amorphous powder with a molecular weight of 1004.83.

It is freely soluble in water. Each vial of fosaprepitant for injection for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: edetate disodium (5.4 mg), polysorbate 80 (75 mg), lactose anhydrous (375 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment). Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients taking fosaprepitant for injection. Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, flushing, difficulty in breathing or swallowing, or dizziness, rapid or weak heartbeat or feeling faint [see Warnings and Precautions (5.2) ] .

Infusion Site Reactions Advise patients to seek medical attention if they experience new or worsening signs or symptoms of an infusion site reaction, such as erythema, edema, pain, necrosis, vasculitis, or thrombophlebitis at or near the infusion site [see Warnings and Precautions (5.3) ] . Drug Interactions Advise patients to discuss all medications they are taking, including other prescription, non-prescription medication or herbal products [see Contraindications (4) , Warnings and Precautions (5.1) ]. Warfarin: Instruct patients on chronic warfarin therapy to follow instructions from their healthcare provider regarding blood draws to monitor their INR during the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant for injection with each chemotherapy cycle [see Warnings and Precautions (5.4) ] .

Hormonal Contraceptives: Advise patients that administration of fosaprepitant for injection may reduce the efficacy of hormonal contraceptives. Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with fosaprepitant for injection and for 1 month following administration of fosaprepitant for injection [see Warnings and Precautions (5.5) , Use in Specific Populations (8.3) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Aprepitant after Fosaprepitant Administration Following administration of a single intravenous 150-mg dose of fosaprepitant, a prodrug of aprepitant administered as a 20-minute infusion to healthy subjects, the mean AUC 0-∞ of aprepitant was 37.4 (± 14.8) mcg∙hr/mL and the mean maximal aprepitant concentration (C max ) was 4.2 (± 1.2) mcg/mL. Plasma concentrations of fosaprepitant are below the limits of quantification (10 ng/mL) within 30 minutes of the completion of infusion. Distribution Aprepitant is greater than 95% bound to plasma proteins.

The mean apparent volume of distribution at steady state (Vd ss ) was approximately 70 L in humans. Aprepitant crosses the blood brain barrier in humans [see Clinical Pharmacology (12.1) ] . Elimination Metabolism Fosaprepitant is converted to aprepitant in in vitro incubations with human liver preparations and in S9 preparations from multiple other human tissues including kidney, lung and ileum.

Thus, it appears that the conversion of fosaprepitant to aprepitant can occur in multiple extrahepatic tissues in addition to the liver. Aprepitant undergoes extensive metabolism. In vitro studies using human liver microsomes indicate that aprepitant is metabolized primarily by CYP3A4 with minor metabolism by CYP1A2 and CYP2C19.

Metabolism is largely via oxidation at the morpholine ring and its side chains. No metabolism by CYP2D6, CYP2C9, or CYP2E1 was detected. In healthy young adults, aprepitant accounts for approximately 24% of the radioactivity in plasma over 72 hours following a single oral 300-mg dose of [ 14 C]-aprepitant, indicating a substantial presence of metabolites in the plasma.

Seven metabolites of aprepitant, which are only weakly active, have been identified in human plasma. Excretion Following administration of a single intravenous 100-mg dose of [ 14 C]-fosaprepitant to healthy subjects, 57% of the radioactivity was recovered in urine and 45% in feces. Aprepitant is eliminated primarily by metabolism; aprepitant is not renally excreted.

The apparent terminal half-life ranged from approximately 9 to 13 hours. Specific Populations Age: Geriatric Population Following oral administration of a single 125-mg dose of aprepitant on Day 1 and 80 mg once daily on Days 2 through 5, the AUC 0-24hr of aprepitant was 21% higher on Day 1 and 36% higher on Day 5 in elderly (65 years and older) relative to younger adults. The C max was 10% higher on Day 1 and 24% higher on Day 5 in elderly relative to younger adults.

These differences are not considered clinically meaningful [see Use in Specific Populations (8.5) ] . Age: Pediatric Population Single-Dose Fosaprepitant for Injection Regimen: Simulated systemic exposures of aprepitant in patients 2 years to less than 12 years and observed systemic exposures in patients 6 months to less than 2 years and 12 to 17 years are shown in Table 9, including AUC 0-24hr , peak plasma concentration (C max ) on Day 1 and concentrations at the end of Day 1 (C 24 ), Day 2 (C 48 ) and Day 3 (C 72 ).

Table 9 Systemic Exposures of Aprepitant for Single-Dose Fosaprepitant for Injection Regimen in Pediatric Patients Population Single-Dose of Fosaprepitant for Injection Regimen Geometric Mean AUC 0-24hr. (mcg*hr/mL) C max (mcg/mL) C 24 (mcg/mL) C 48 (mcg/mL) C 72 (mcg/mL) 12 Years to 17 Years 150 mg 29.4 3.4

0.7ND ND = Not Determined. Pharmacokinetic samples were not collected to support the parameter value of interest. ND 6 Years to less than 12 Years 4 mg/kg 35.2 3.6 0.7 0.2 0.05 2 Years to less than 6 Years 28.2 3.1 0.4 0.1 0.02 6 Months to less than 2 Years 5 mg/kg 32.7 3.3

0.4NE NE = Not Estimated. The geometric mean could not be estimated due to values being below the limitation of quantification. ND *ND = Not Determined. Pharmacokinetic samples were not collected to support the parameter value of interest. † NE = Not Estimated. The geometric mean could not be estimated due to values being below the limitation of quantification. 3-D… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 31 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology In a randomized, double-blind, positive-controlled, thorough QTc study, a single 200-mg dose of fosaprepitant (approximately 1.3 times the recommended dose) had no effect on the QTc interval.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Prevention of Nausea and Vomiting Associated with HEC in Adults In a randomized, parallel, double-blind, active-controlled study, fosaprepitant for injection 150 mg as a single intravenous infusion (N=1147) was compared to a 3-day oral aprepitant regimen (N=1175) in patients receiving a HEC regimen that included cisplatin (≥70 mg/m 2 ). All patients in both groups received dexamethasone and ondansetron (see Table 12). Patient demographics were similar between the two treatment groups.

Of the total 2322 patients, 63% were men, 56% White, 26% Asian, 3% American Indian/Alaska Native, 2% Black, 13% Multi-Racial, and 33% Hispanic/Latino ethnicity. Patient ages ranged from 19 to 86 years of age, with a mean age of 56 years. Other concomitant chemotherapy agents commonly administered were fluorouracil (17%), gemcitabine (16%), paclitaxel (15%), and etoposide (12%).

Table 12 Treatment Regimens in Adult HEC Trial Fosaprepitant for Injection placebo, aprepitant capsules placebo and dexamethasone placebo (in the evenings on Days 3 and 4) were used to maintain blinding. Day 1 Day 2 Day 3 Day 4 Fosaprepitant/Aprepitant Regimen Fosaprepitant for Injection 150 mg intravenously over 20 to 30 minutes approximately 30 minutes prior to chemotherapy none none none Oral dexamethasone Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4.

Dexamethasone was also administered in the evenings on Days 3 and 4. The 12 mg dose of dexamethasone on Day 1 and the 8 mg once daily dose on Day 2 reflects a dosage adjustment to account for a drug interaction with the fosaprepitant for injection regimen [see Clinical Pharmacology (12.3) ]. 12 mg 8 mg 8 mg twice daily 8 mg twice daily Ondansetron Ondansetron Ondansetron 32 mg intravenous was used in the clinical trials of fosaprepitant.

Although this dose was used in clinical trials, this is no longer the currently recommended dose. Refer to the ondansetron prescribing information for the current recommended dose. none none none Oral Aprepitant Regimen Aprepitant capsules 125 mg 80 mg 80 mg none Oral dexamethasone Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The 12 mg dose of dexamethasone on Day 1 and the 8 mg once daily dose on Days 2 through 4 reflects a dosage adjustment to account for a drug interaction with the oral aprepitant regimen [see Clinical Pharmacology (12.3) ].

12 mg 8 mg 8 mg 8 mg Ondansetron Ondansetron none none none The efficacy of fosaprepitant for injection was evaluated based on the primary and secondary endpoints listed in Table 13 and was shown to be non-inferior to that of the 3-day oral aprepitant regimen with regard to complete response in each of the evaluated phases. The pre-specified non-inferiority margin for complete response in the overall phase was 7%. The pre-specified non-inferiority margin for complete response in the delayed phase was 7.3%.

The pre-specified non-inferiority margin for no vomiting in the overall phase was 8.2%. Table 13 Percent of Adult Patients Receiving HEC Responding by Treatment Group and Phase — Cycle 1 ENDPOINTS Fosaprepitant for Injection Regimen (N = 1106) N: Number of patients included in the primary analysis of complete response. % Oral Aprepitant Regimen (N = 1134) % Difference Difference and Confidence interval (CI) were calculated using the method proposed by Miettinen and Nurminen and adjusted for Gender. (95% CI) PRIMARY ENDPOINT Complete Response Complete Response = no vomiting and no use of rescue therapy.

Overall Overall = 0 to 120 hours post-initiation of cisplatin chemotherapy. 71.9 72.3 -0.4 (-4.1, 3.3) SECONDARY ENDPOINTS Complete Response Delayed phase Delayed phase = 25 to 120 hours post-initiation of cisplatin chemotherapy. 74.3 74.2 0.1 (-3.5, 3.7) No Vomiting Overall 72.9 74.6 -1.7 (-5.3, 2.0)

14.2Prevention of Nausea and Vomiting Associated with MEC in Adults In… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced systemic exposures to aprepitant approximately equivalent to (female rats) or less than (male rats) the adult human exposure at the RHD of 150 mg.

Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals were treated with oral doses ranging from 2.5 to 2000 mg/kg/day.

The highest dose produced a systemic exposure approximately 2 times the adult human exposure at the RHD of 150 mg. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice. Carcinogenicity studies were not conducted with fosaprepitant.

Mutagenesis Aprepitant and fosaprepitant were not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test and the mouse micronucleus test. Impairment of Fertility Fosaprepitant, when administered intravenously, is rapidly converted to aprepitant. In the fertility studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant.

Oral aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended adult human dose of 150 mg and exposure in female rats approximately equivalent to the adult human exposure).

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

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced systemic exposures to aprepitant approximately equivalent to (female rats) or less than (male rats) the adult human exposure at the RHD of 150 mg.

Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals were treated with oral doses ranging from 2.5 to 2000 mg/kg/day.

The highest dose produced a systemic exposure approximately 2 times the adult human exposure at the RHD of 150 mg. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice. Carcinogenicity studies were not conducted with fosaprepitant.

Mutagenesis Aprepitant and fosaprepitant were not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test and the mouse micronucleus test. Impairment of Fertility Fosaprepitant, when administered intravenously, is rapidly converted to aprepitant. In the fertility studies conducted with fosaprepitant and aprepitant, the highest systemic exposures to aprepitant were obtained following oral administration of aprepitant.

Oral aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended adult human dose of 150 mg and exposure in female rats approximately equivalent to the adult human exposure).

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: August 2025 Patient Information Fosaprepitant (FOS a PREP i tant) for Injection Read this Patient Information before you start receiving fosaprepitant for injection and each time you are scheduled to receive fosaprepitant for injection.

There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. What is fosaprepitant for injection?

Fosaprepitant for Injection is a prescription medicine used with other medicines that treat nausea and vomiting in patients 6 months of age and older to prevent nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines. Fosaprepitant for Injection is not used to treat nausea and vomiting that you already have. It is not known if fosaprepitant for injection is safe and effective in children less than 6 months of age.

Who should not receive fosaprepitant for injection? Do not receive fosaprepitant for injection if you: are allergic to fosaprepitant, aprepitant, or any of the ingredients in fosaprepitant for injection. See the end of this leaflet for a complete list of the ingredients in fosaprepitant for injection. are taking pimozide (ORAP ® ) What should I tell my healthcare provider before receiving fosaprepitant for injection?

Before receiving fosaprepitant for injection, tell your healthcare provider if you: have liver problems are pregnant or plan to become pregnant. It is not known if fosaprepitant for injection can harm your unborn baby. Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, implants, and certain IUDs) should also use a backup method of birth control that does not contain hormones, such as condoms and spermicides, during treatment with fosaprepitant for injection and for 1 month after receiving fosaprepitant for injection. are breastfeeding or plan to breastfeed.

It is not known if fosaprepitant for injection passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive fosaprepitant for injection. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Fosaprepitant for Injection may affect the way other medicines work, and other medicines may affect the way fosaprepitant for injection works, causing serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How will I receive fosaprepitant for injection? Adults 18 years of age and older: Fosaprepitant for Injection will be given on Day 1 of chemotherapy treatment. It will be given to you by intravenous (IV) infusion in your vein about 50 to 60 minutes before you start your chemotherapy treatment.

Children 6 months to 17 years of age: Fosaprepitant for Injection will be given to your child by intravenous (IV) infusion into a large vein through a type of IV line called a central venous catheter, about 1 hour to 1 ½ hours before the start of their chemotherapy treatment. Depending on the chemotherapy treatment, there are 2 ways that fosaprepitant for injection may be given: Fosaprepitant for injection is given on Day 1 only (single day of chemotherapy). Fosaprepitant for injection is given on Days 1, 2, and 3 (single or multiple days of chemotherapy).

Your child may receive capsules of aprepitant or an oral suspension of aprepitant instead of fosaprepitant for injection on Days 2 and 3. If your child will receive either of these, see the Patient Information for aprepitant capsules or aprepitant for oral suspension for further information. If you take the blood thinner medicine warfarin sodium (COUMADIN ® , JANTOVEN ® ), your healthcare provider may do blood tests after you receive fosaprepitant for injection to check your bloo… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 5 words ▾

Dosage and Administration (2.2) 5/2022

📄 Package Label / Principal Display Panel 101 words ▾

PRINCIPAL DISPLAY PANEL - 150 mg Vial Label NDC 0143- 9384 -01 Rx only Fosaprepitant for Injection 150 mg per vial Single Dose Vial Discard unused portion Vial label

PRINCIPAL DISPLAY PANEL - 150 mg Carton Label NDC 0143- 9384 -01 Rx only Fosaprepitant for Injection 150 mg per vial Reconstitute with 5 mL of 0.9% Sodium Chloride for Injection STERILE LYOPHILIZED POWDER FOR INTRAVENOUS USE ONLY AFTER RECONSTITUTION AND DILUTION DO NOT USE WITH SOLUTIONS CONTAINING DIVALENT CATIONS (e.g., Ca 2+ , Mg 2+ ) INCLUDING LACTATED RINGER'S SOLUTION AND HARTMANN'S SOLUTION . Single Dose Vial Discard unused portion carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.9K
Units reimbursed last 4 qtrs
3.7K
Gross reimbursed last 4 qtrs
$394.9K
Avg / prescription
$101.69
Avg / unit
$105.88
Latest quarter Q1 2026
816Rx
Fee-for-service vs managed care ⓘ
28% FFS 72% MCO
Fee-for-service · 1,102 Rx Managed care · 2,781 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 64 units · 0.8 per 100k residents WA Idaho: 147 units · 7.5 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 131 units · 2.3 per 100k residents MN Wisconsin: 171 units · 2.9 per 100k residents WI Michigan: no data reported MI New York: 105 units · 0.5 per 100k residents NY Vermont: no data reported VT New Hampshire: 111 units · 7.9 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 39 units · 1.2 per 100k residents IA Illinois: no data reported IL Indiana: 959 units · 14.0 per 100k residents IN Ohio: 127 units · 1.1 per 100k residents OH Pennsylvania: 80 units · 0.6 per 100k residents PA New Jersey: 148 units · 1.6 per 100k residents NJ Massachusetts: 12 units · 0.2 per 100k residents MA California: 434 units · 1.1 per 100k residents CA Utah: no data reported UT Colorado: 3 units · 0.1 per 100k residents CO Nebraska: no data reported NE Missouri: 118 units · 1.9 per 100k residents MO Kentucky: 148 units · 3.3 per 100k residents KY West Virginia: 24 units · 1.4 per 100k residents WV Virginia: 27 units · 0.3 per 100k residents VA Maryland: no data reported MD Connecticut: 28 units · 0.8 per 100k residents CT Rhode Island: 31 units · 2.8 per 100k residents RI Arizona: 198 units · 2.7 per 100k residents AZ New Mexico: no data reported NM Kansas: 9 units · 0.3 per 100k residents KS Arkansas: 10 units · 0.3 per 100k residents AR Tennessee: no data reported TN North Carolina: 27 units · 0.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 80 units · 1.7 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 249 units · 17.4 per 100k residents HI Texas: 248 units · 0.8 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.117.4
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 Hawaii 17.4 /100k
2 Indiana 14.0 /100k
3 New Hampshire 7.9 /100k
4 Idaho 7.5 /100k
5 Kentucky 3.3 /100k
6 Wisconsin 2.9 /100k
7 Rhode Island 2.8 /100k
8 Arizona 2.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Fosaprepitant Dimeglumine — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Fosaprepitant Dimeglumine. 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
$136.1K
Claims incl. refills
783
Beneficiaries
354
Spend / beneficiary
$384.37
Spend / claim
$173.78
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.

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 — Not published for this NDC No photo available yet for this listing.
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 ✓ Available
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 Hikma Pharmaceuticals USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hikma Pharmaceuticals USA 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1453 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00143-9383-10 · Hikma 00143-9385-01 · Hikma →
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.