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Fluticasone Propionate 50 ug Spray, Metered, 1 spray — NDC 70518-0880-00 package photo

Fluticasone Propionate 50 ug Spray, Metered, 1 spray

by REMEDYREPACK INC. · 1 SPRAY, METERED in 1 CARTON (70518-0880-0)
NDC 70518-0880-00
🏷️ FDA NDC (as labeled) 70518-0880-0 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

⚠️
Other active recalls for Fluticasone Propionate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 14, 2024 — CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex (Golden State Medical Supply Inc.) · FDA recall D-0349-2024
Class II · Feb 9, 2024 — CGMP Deviations: potential presence of Burkholderia cepacia complex (Apotex Corp.) · FDA recall D-0326-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70518-0880-0
Product NDC 70518-0880
11-digit billing NDC 70518088000
RxCUI 1797907
UNII O2GMZ0LF5W
Application # ANDA076504
SPL Set ID 3c7e3ae6-a78f-4023-a2d4-543615ae25b0
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-15
Route NASAL
Dosage form SPRAY, METERED
Substance FLUTICASONE PROPIONATE
GCN Seq No 018368
GCN 62263
HICL code 007873
Ingredient (HICL) Fluticasone Propionate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7P
Therapeutic class — specific (HIC3) Nasal Anti-Inflammatory Steroids
AHFS code 48:10.08.00
AHFS class Corticosteroids (Respiratory Tract)
FDB label name FLUTICASONE PROP 50 MCG SPRAY
FDB brand name Fluticasone Propionate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 70518-0880-0 — a 5-4-1 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 package segment → 70518-0880-00. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, Glucocorticoids
How it works Corticosteroid Hormone Receptor Agonists
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.

🏭 Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA076504 (ANDA)
Labeler code70518
First marketedMar 2018
Product typeHuman Prescription Drug
Portfolio1,511 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.

🩺 Clinical

Label name FLUTICASONE PROP 50 MCG SPRAY Ingredient Fluticasone Propionate
📖 What it is MedlinePlus · NLM

Nonprescription (over the counter) fluticasone nasal spray is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription fluticasone nasal spray is used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies. Prescription fluticasone nasal spray (Xhance) is used to treat chronic rhinosinusitis with or without nasal polyps (ongoing runny nose, sinus swelling and/or nasal co...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
📖 Read our full Fluticasone guide →
8
Nutrient depletion considerations

Fluticasone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Fluticasone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

🧪 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.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • UNII ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • 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.

6 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.

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.7375 —
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fluticasone Propionate 50 ug 00054-3270-99 Hikma 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ug 60505-0829-01 Apotex 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate spray, metered 50 ug 62135-0810-61 Chartwell 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ug 71085-0090-16 IPG 1 bottle $0.448 AB Availability likely —
Fluticasone Propionate 50 ug 72888-0141-35 Advagen 1 bottle $0.448 AB Availability likely —
good neighbor pharmacy fluticasone propionate 50 ug 46122-0684-29 Amerisource 1 bottle $0.692 — Availability likely —
Fluticasone Propionate 50 ug 83324-0294-01 Chain 1 bottle $0.692 — Availability likely —
leader fluticasone propionate 50 ug 70000-0703-01 Cardinal 1 bottle $0.813 — Availability likely —
Foster and Thrive Allergy Relief 50 ug 70677-1021-01 Strategic 1 bottle $0.813 — Availability likely —
Good Sense 24 hour allergy nasal 50 ug 00113-0028-01 L. 1 bottle $0.845 — Discontinued —
Rugby Fluticasone Propionate Nasal 50 ug 00536-1183-65 Rugby 1 bottle $0.897 — Availability likely —
Fluticasone Propionate 50 ug 60505-6205-03 Apotex 1 bottle $0.897 — Availability likely —
Good Sense 24 hour allergy nasal 50 ug 00113-0285-08 L. 1 bottle — — FDA listed —
Flonase Allergy Relief 50 ug 00135-0576-01 Haleon 1 bottle — — FDA listed —
Childrens Flonase Allergy Relief 50 ug 00135-0582-04 Haleon 1 bottle — — FDA listed —
24 Hour Allergy Nasal 50 ug 00363-0024-01 Walgreen 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 00363-0652-01 Walgreens 1 bottle — — FDA listed —
Childrens Allergy Relief 50 ug 00363-4023-08 Walgreen 1 bottle — — FDA listed —
Up and Up Allergy Relief Nasal 50 ug 11673-0103-04 Target 3 bottles — — Discontinued —
Fluticasone Propionate 50 ug 11673-0262-01 Target 1 bottle — — Discontinued —
allergy nasal 50 ug 11822-0901-03 Rite 1 bottle — — FDA listed —
Signature Care Allergy Relief 50 ug 21130-0089-08 Safeway 1 bottle — — Discontinued —
signature care childrens allergy relief 50 ug 21130-0122-08 Safeway 1 bottle — — Discontinued —
childrens allergy relief 50 ug 21130-0607-08 Safeway 1 bottle — — FDA listed —
allergy relief 50 ug 21130-0863-08 Safeway 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 30142-0258-01 The 1 bottle — — FDA listed —
TopCare Childrens Allergy Relief Nasal 24 Hour 50 ug 36800-0128-02 Topco 1 bottle — — Discontinued —
topcare fluticasone propionate nasal 50 ug 36800-0222-01 Topco 1 bottle — — FDA listed —
Nasopro 24 50 ug 37808-0205-02 H 1 bottle — — Discontinued —
Childrens Nasopro 50 ug 37808-0340-08 H 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 37835-0997-31 Bi-Mart 1 bottle — — FDA listed —
Equaline Fluticasone Propionate 50 ug 41163-0023-01 United 1 bottle — — Discontinued —
Allergy Relief 50 ug 41250-0634-08 Meijer 1 bottle — — FDA listed —
careone childrens allergy relief 50 ug 41520-0553-02 American 1 bottle — — FDA listed —
CareOne Allergy Relief 50 ug 41520-0703-01 American 1 bottle — — FDA listed —
allergy relief nasal 50 ug 42507-0710-08 HyVee 1 bottle — — FDA listed —
365 Whole Foods Market Fluticasone Propionate 50 ug 42681-0058-01 Whole 1 bottle — — FDA listed —
equate allergy relief 50 ug 49035-0200-01 Wal-Mart 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 49035-0362-01 Walmart 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 50090-0968-00 A-S 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 50090-2880-00 A-S 1 bottle — AB FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 50090-6823-00 A-S 1 bottle — — FDA listed —
allergy nasal 50 ug 51316-0181-08 CVS 1 bottle — — FDA listed —
Childrens Allergy 50 ug 51316-0197-08 CVS 1 bottle — — FDA listed —
Allergy Relief 50 ug 51316-0497-08 CVS 1 bottle — — FDA listed —
childrens allergy relief 50 ug 51316-0818-08 CVS 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 51407-0871-12 Golden 1 bottle — AB FDA listed —
Allergy Relief 50 ug 53943-0006-01 Discount 1 bottle — — FDA listed —
exchange select allergy relief 50 ug 55301-0506-01 Army 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55319-0058-01 Family 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55681-0389-14 TWIN 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 55700-0714-16 Quality 1 bottle — AB FDA listed —
DG Health childrens allergy relief nasal 50 ug 55910-0607-02 Dolgencorp 1 bottle — — FDA listed —
DG Health Allergy Relief Nasal 50 ug 55910-0773-01 Dolgencorp 1 bottle — — FDA listed —
allergy relief nasal 50 ug 56062-0107-08 Publix 1 bottle — — FDA listed —
Fluticare 50 ug 57483-0180-11 INNOVUS 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 58602-0017-42 Aurohealth 1 bottle — — FDA listed —
Childrens Fluticasone Propionate 50 ug 58602-0018-04 Aurohealth 3 bottles — — FDA listed —
Allergy Relief 50 ug 59726-0203-38 P 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 60429-0195-15 Golden 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 60505-0955-01 Apotex 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 63187-0638-16 Proficient 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 63187-0806-16 Proficient 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 63654-0380-01 Selder, 1 bottle — — FDA listed —
Kirkland Signature Aller Flo 50 ug 63981-0001-01 Costco 120 sprays — — FDA listed —
Welby Fluticasone 50 ug 64024-0007-02 Aldi 1 bottle — — FDA listed —
Allergy Relief 50 ug 64525-6560-02 Quality 1 bottle — — FDA listed —
Good Sense 24 hour allergy nasal 50 ug 67296-1463-01 RedPharm 11 sprays — — FDA listed —
Fluticasone 50 ug 68071-1638-05 NuCare 16 sprays — AB FDA listed —
Fluticasone Propionate 50 ug 68071-3949-05 NuCare 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68071-4868-05 NuCare 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68196-0210-01 Sam's 6 bottles — — Discontinued —
Fluticasone Propionate 50 ug 68196-0503-01 Sam's 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 68788-4120-01 Preferred 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68788-8446-01 Preferred 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 68788-9678-01 Preferred 1 bottle — AB FDA listed —
Allergy Relief Nasal 50 ug 68998-0452-01 Marc 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 68998-0600-01 Marc 1 bottle — — Discontinued —
Fluticasone Propionate 50 ug 69168-0014-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0380-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0448-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 69168-0452-01 Allegiant 1 bottle — — FDA listed —
Fluticasone Propionate Nasal 50 ug 69842-0900-01 CVS 1 bottle — — Discontinued —
Fluticasone Propionate 50 ugthis 70518-0880-00 REMEDYREPACK 1 spray — AB FDA listed —
Fluticasone Propionate 50 ug 70518-1655-00 REMEDYREPACK 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 72189-0004-01 Direct_RX 1 spray — AB FDA listed —
basic care allergy relief nasal 50 ug 72288-0119-04 Amazon.com 3 bottles — — Discontinued —
basic care childrens allergy relief nasal 50 ug 72288-0333-08 Amazon.com 1 bottle — — FDA listed —
Fluticasone Propionate ALLERGY RELIEF 50 ug 72657-0159-12 GLENMARK 1 bottle — — FDA listed —
Mucinex Nasal Congestion and Allergy Relief 50 ug 72854-0227-60 Reckitt 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 72888-0248-01 Advagen 1 bottle — — FDA listed —
Topcare Allergy Relief Nasal 50 ug 76162-0121-08 Topco 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug/.1g 76420-0106-16 Asclemed 16 g — — FDA listed —
Fluticasone Propionate 50 ug 76420-0329-50 Asclemed 1 bottle — AB FDA listed —
Fluticasone Propionate 50 ug 76420-0903-01 Asclemed 1 bottle — AB FDA listed —
Equate Allergy Relief 50 ug 79903-0071-10 WALMART 2 bottles — — FDA listed —
Equate Childrens Allergy Relief 50 ug 79903-0295-72 WALMART 1 bottle — — FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 85766-0161-12 Sportpharm 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 85828-0448-01 Grocery 1 bottle — — FDA listed —
Rugby Fluticasone Propionate Nasal 50 ug 87063-0114-12 ASCLEMED 1 bottle — — FDA listed —
Childrens Fluticasone Propionate ALLERGY RELIEF 50 ug 72657-0166-72 GLENMARK 1 bottle — — FDA listed —
Allergy Relief Nasal 50 ug 72288-0349-09 Amazon.com 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 59726-0350-38 P 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 68462-0918-20 Glenmark 1 bottle — — FDA listed —
Fluticasone 50 ug 73581-0535-01 YYBA 1 bottle — — FDA listed —
Fluticasone Propionate 50 ug 73581-0510-01 YYBA 1 bottle — — FDA listed —
Fluticasone Propionate ALLERGY RELIEF 50 ug 73581-0530-01 YYBA 1 bottle — — 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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 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.

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

Medicare Part D (outpatient prescription) spending for Fluticasone Propionate — the program that covers self-administered drugs. 10 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 Fluticasone Propionate. 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
$55.37M
Claims incl. refills
3.4M
Beneficiaries
2.6M
Spend / beneficiary
$21.45
Spend / claim
$16.15
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Fluticasone Propionate — the ingredient across all brands.

Top reported reactions

Dyspnoea21,832
Asthma12,800
Cough11,446
Fatigue11,026
Headache10,628
Pneumonia10,087
Nausea9,027

Age at onset

Neonate22
Infant24
Child935
Adolescent723
Adult16,314
Elderly10,793

Reporter sex

192,102 reports
Male · 33%
Female · 67%
Unknown · 0%

Serious outcomes

Hospitalization45,985
Life-threatening3,495
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 11,910 6,070
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70518-0880-00 You're viewing this 1 SPRAY, METERED in 1 CARTON (70518-0880-0) 2018-03-15 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70518-0880-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70518-0880-00, written without dashes as 70518088000. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70518-0880-00, the first segment (70518) is the labeler code FDA assigned to REMEDYREPACK INC.; the middle segment (0880) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REMEDYREPACK 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 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
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older. Fluticasone propionate nasal spray is a corticosteroid indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. (1)

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administer fluticasone propionate nasal spray by the intranasal route only. Prime fluticasone propionate nasal spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face. Shake fluticasone propionate nasal spray gently before each use.

Patients should use fluticasone propionate nasal spray at regular intervals since its effectiveness depends on its regular use. Maximum effect may take several days and individual patients will experience a variable time to onset and different degree of symptom relief. For intranasal use only.

Recommended starting dosages: Adults: 2 sprays per nostril once daily (200 mcg per day). (2.1) Adolescents and children aged 4 years and older: 1 spray per nostril once daily (100 mcg per day). (2.2)

2.1Adults The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dose to 1 spray in each nostril once daily for maintenance therapy.

Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.

2.2Adolescents and Children (Aged 4 Years and Older) The recommended starting dosage in adolescents and children, aged 4 years and older is 1 spray in each nostril once daily (total daily dose, 100 mcg). Patients not adequately responding to 1 spray in each nostril may use 2 sprays in each nostril once daily (total daily dose, 200 mcg). Once adequate control is achieved, the dosage should be decreased to 1 spray in each nostril once daily.

The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS AND STRENGTHS Fluticasone propionate nasal spray USP is a nasal spray suspension. Each 100 mg spray delivers 50 mcg of fluticasone propionate USP. Nasal spray: 50 mcg of fluticasone propionate USP in each 100 mg spray. (3)

⛔ Contraindications 31 words ▾

4 CONTRAINDICATIONS Fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.3) , Description (11)] . Hypersensitivity to any ingredient. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.

(5.1) Close monitoring for glaucoma and cataracts is warranted. (5.2) Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have been reported after administration of fluticasone propionate nasal spray. Discontinue fluticasone propionate nasal spray if such reactions occur.

(5.3) Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

(5.4) Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue fluticasone propionate nasal spray slowly. (5.5) Monitor growth of pediatric patients.

(5.7)

5.1Local Nasal Effects Epistaxis : In clinical trials of 2 to 26 weeks’ duration, epistaxis was observed more frequently in subjects treated with fluticasone propionate nasal spray than those who received placebo [see Adverse Reactions (6.1)] . Nasal Ulceration : Postmarketing cases of nasal ulceration have been reported in patients treated with fluticasone propionate nasal spray [see Adverse Reactions (6.2)] . Candida Infection : In clinical trials with fluticasone propionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred.

When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of fluticasone propionate nasal spray. Patients using fluticasone propionate nasal spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa. Nasal Septal Perforation : Postmarketing cases of nasal septal perforation have been reported in patients treated with fluticasone propionate nasal spray [see Adverse Reactions (6.2)] .

Impaired Wound Healing : Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should avoid using fluticasone propionate nasal spray until healing has occurred.

5.2Glaucoma and Cataracts Use of intranasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

5.3Hypersensitivity Reactions including Anaphylaxis Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, and rash) have been reported after administration of fluticasone propionate nasal spray. Discontinue fluticasone propionate nasal spray if such reactions occur [see Contraindications (4)] . Rarely, immediate hypersensitivity reactions may occur after the administration of fluticasone propionate nasal spray.

5.4Immunosuppression Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure.

How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is e…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing [see Warnings and Precautions (5.1)] Cataracts and glaucoma [see Warnings and Precautions (5.2)] Immunosuppression [see Warnings and Precautions (5.4)] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.5)] Effect on growth [see Warnings and Precautions (5.7)] The most common adverse reactions (>3%) are headache, pharyngitis, epistaxis, nasal burning/nasal irritation, nausea/vomiting, asthma symptoms, and cough.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In controlled US clinical trials, more than 3,300 subjects with allergic and nonallergic rhinitis received treatment with intranasal fluticasone propionate. In general, adverse reactions in clinical trials have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions were reported with approximately the same frequency by subjects treated with placebo.

Less than 2% of subjects in clinical trials discontinued because of adverse reactions; this rate was similar for vehicle placebo and active comparators. The safety data described below are based on 7 placebo-controlled clinical trials in subjects with allergic rhinitis. The 7 trials included 536 subjects (57 girls and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) treated with fluticasone propionate nasal spray 200 mcg once daily over 2 to 4 weeks and 2 placebo-controlled clinical trials which included 246 subjects (119 female and 127 male adolescents and adults) treated with fluticasone propionate nasal spray 200 mcg once daily over 6 months (Table 1).

Also included in Table 1 are adverse reactions from 2 trials in which 167 children (45 girls and 122 boys aged 4 to 11 years) were treated with fluticasone propionate nasal spray 100 mcg once daily for 2 to 4 weeks. Table 1: Adverse Reactions with Fluticasone Propionate Nasal Spray with >3% Incidence and More Common than Placebo in Subjects ≥ 4 Years with Allergic Rhinitis Adverse Reaction Fluticasone Propionate 100 mcg Once Daily (N = 167) % Fluticasone Propionate 200 mcg Once Daily (N = 782) % Placebo (N = 758) % Headache 6.6 16.1

14.6Pharyngitis 6 7.8

7.2Epistaxis 6 6.9

5.4Nasal Burning/Nasal Irritation 2.4 3.2

2.6Nausea/Vomiting 4.8 2.6 2 Asthma Symptoms 7.2 3.3

2.9Cough 3.6 3.8

2.8Other adverse reactions with fluticasone propionate nasal spray observed with an incidence less than or equal to 3% but greater than or equal to 1% and more common than with placebo included: blood in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like symptoms, aches and pains, dizziness, and bronchitis.

6.2Postmarketing Experience In addition to adverse events reported from clinical trials, the following adverse events have been identified during postapproval use of intranasal fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

General Disorders and Administration Site Conditions : Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/an…

🔄 Drug Interactions 196 words ▾

7 DRUG INTERACTIONS Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. (7.1)

7.1Inhibitors of Cytochrome P450 3A4 Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with fluticasone propionate nasal spray is not recommended because increased systemic corticosteroid adverse effects may occur. Ritonavir : A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3)].

During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate products, including fluticasone propionate nasal spray, with ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Ketoconazole : Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic impairment: Monitor patients for signs of increased drug exposure. (8.6)

8.1Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled trials with fluticasone propionate nasal spray in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal spray. Mice and rats at fluticasone propionate doses approximately 1 and 4 times, respectively, the maximum recommended human daily intranasal dose (MRHDID) for adults (on a mg/m 2 basis at maternal subcutaneous doses of 45 and 100 mcg/kg/day, respectively) showed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification.

No teratogenicity was seen in rats at doses up to 3 times the MRHDID (on a mg/m 2 basis at maternal inhalation doses up to 68.7 mcg/kg/day). In rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose approximately 0.3 times the MRHDID for adults (on a mg/m 2 basis at a maternal subcutaneous dose of 4 mcg/kg/day). However, no teratogenic effects were reported at fluticasone propionate doses up to approximately 20 times the MRHDID for adults (on a mg/m 2 basis at a maternal oral dose up to 300 mcg/kg/day).

No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration [see Clinical Pharmacology (12.3)]. Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy. Nonteratogenic Effects Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

8.3Nursing Mothers It is not known whether fluticasone propionate is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Subcutaneous administration to lactating rats of tritiated fluticasone propionate at a dose approximately 0.4 times the MRHDID for adults on a mg/m 2 basis resulted in measurable radioactivity in milk.

Since there are no data from controlled trials on the use of intranasal fluticasone propionate nasal spray by nursing mothers, caution should be exercised when fluticasone propionate nasal spray is administered to a nursing woman.

8.4Pediatric Use The safety and effectiveness of fluticasone propionate nasal spray in children aged 4 years and older have been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3)] . Six hundred fifty (650) subjects aged 4 to 11 years and 440 subjects aged 12 to 17 years were studied in US clinical trials with fluticasone propionate nasal spray. The safety and effectiveness of fluticasone propionate nasal spray in children younger than 4 years have not been established.

Effects on Growth : Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. This effect was observed in the absence of laboratory evidence of hypothalamic-pituita…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled trials with fluticasone propionate nasal spray in pregnant women. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal spray. Mice and rats at fluticasone propionate doses approximately 1 and 4 times, respectively, the maximum recommended human daily intranasal dose (MRHDID) for adults (on a mg/m 2 basis at maternal subcutaneous doses of 45 and 100 mcg/kg/day, respectively) showed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification.

No teratogenicity was seen in rats at doses up to 3 times the MRHDID (on a mg/m 2 basis at maternal inhalation doses up to 68.7 mcg/kg/day). In rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose approximately 0.3 times the MRHDID for adults (on a mg/m 2 basis at a maternal subcutaneous dose of 4 mcg/kg/day). However, no teratogenic effects were reported at fluticasone propionate doses up to approximately 20 times the MRHDID for adults (on a mg/m 2 basis at a maternal oral dose up to 300 mcg/kg/day).

No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration [see Clinical Pharmacology (12.3)]. Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans.

In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy. Nonteratogenic Effects Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of fluticasone propionate nasal spray in children aged 4 years and older have been established [see Adverse Reactions (6.1), Clinical Pharmacology (12.3)] . Six hundred fifty (650) subjects aged 4 to 11 years and 440 subjects aged 12 to 17 years were studied in US clinical trials with fluticasone propionate nasal spray. The safety and effectiveness of fluticasone propionate nasal spray in children younger than 4 years have not been established.

Effects on Growth : Controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. This effect was observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown.

The potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including fluticasone propionate nasal spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies.

To minimize the systemic effects of intranasal corticosteroids, including fluticasone propionate nasal spray, each patient’s dosage should be titrated to the lowest dosage that effectively controls his/her symptoms. A 1-year placebo-controlled trial was conducted in 150 pediatric subjects (aged 3 to 9 years) to assess the effect of fluticasone propionate nasal spray (single daily dose of 200 mcg) on growth velocity. From the primary population receiving fluticasone propionate nasal spray (n=56) and placebo (n=52), the point estimate for growth velocity with fluticasone propionate nasal spray was 0.14 cm/year lower than placebo (95% CI:-0.54, 0.27 cm/year).

Thus, no statistically significant effect on growth was noted compared with placebo. No evidence of clinically relevant changes in HPA axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively. The potential for fluticasone propionate nasal spray to cause growth suppression in susceptible patients or when given at higher than recommended dosages cannot be ruled out.

🧓 Geriatric Use 102 words ▾

8.5Geriatric Use A limited number of subjects aged 65 years and older (n=129) or 75 years and older (n=11) have been treated with fluticasone propionate nasal spray in clinical trials. While the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 150 words ▾

10 OVERDOSAGE Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]. Intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate twice daily for 7 days was administered to healthy human volunteers. Adverse events reported with fluticasone propionate were similar to placebo, and no clinically significant abnormalities in laboratory safety tests were observed.

Single oral doses up to 16 mg have been studied in human volunteers with no acute toxic effects reported. Repeat oral doses up to 80 mg daily for 10 days in volunteers and repeat oral doses up to 10 mg daily for 14 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.

Acute overdosage with this dosage form is unlikely since one bottle of fluticasone propionate nasal spray contains approximately 8 mg of fluticasone propionate.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fluticasone propionate is a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.

The clinical significance of these findings is unknown. The precise mechanism through which fluticasone propionate affects rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

In 7 trials in adults, fluticasone propionate nasal spray has decreased nasal mucosal eosinophils in 66% of patients (35% for placebo) and basophils in 39% of patients (28% for placebo). The direct relationship of these findings to long-term symptom relief is not known.

12.2Pharmacodynamics HPA Axis Effect : The potential systemic effects of fluticasone propionate nasal spray on the HPA axis were evaluated. Fluticasone propionate nasal spray given as 200 mcg once daily or 400 mcg twice daily was compared with placebo or oral prednisone 7.5 or 15 mg given in the morning. Fluticasone propionate nasal spray at either dosage for 4 weeks did not affect the adrenal response to 6-hour cosyntropin stimulation, while both dosages of oral prednisone significantly reduced the response to cosyntropin.

Cardiac Electrophysiology : A study specifically designed to evaluate the effect of fluticasone propionate nasal spray on the QT interval has not been conducted.

12.3Pharmacokinetics The activity of fluticasone propionate nasal spray is due to the parent drug, fluticasone propionate. Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration. Absorption : Indirect calculations indicate that fluticasone propionate delivered by the intranasal route has an absolute bioavailability averaging less than 2%.

Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate is negligible (<1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver. After intranasal treatment of patients with rhinitis for 3 weeks, fluticasone propionate plasma concentrations were above the level of detection (50 pg/mL) only when recommended doses were exceeded and then only in occasional samples at low plasma levels. Distribution : Following intravenous administration, the initial disposition phase for fluticasone propionate was rapid and consistent with its high lipid solubility and tissue binding.

The volume of distribution averaged

4.2L/kg. The percentage of fluticasone propionate bound to human plasma proteins averaged 99%. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin.

Elimination : Following intravenous dosing, fluticasone propionate showed polyexponential kinetics and had a terminal elimination half-life of approximately 7.8 hours. The total blood clearance of fluticasone propionate is high (average: 1,093 mL/min), with renal clearance accounting for less than 0.02% of the total. Metabolism : The only circulating metabolite detected in man is the 17β-carboxylic acid derivative of fluticasone propionate, which is formed through the CYP3A4 pathway.

This metabolite had less affinity (approximately 1/2,000) than the parent drug for the glucocorticoid receptor of human lung cytosol in vitro and negligible pharmacological activity in animal studies. Other metabolit…

🧬 Mechanism of Action 166 words ▾

12.1Mechanism of Action Fluticasone propionate is a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results.

The clinical significance of these findings is unknown. The precise mechanism through which fluticasone propionate affects rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

In 7 trials in adults, fluticasone propionate nasal spray has decreased nasal mucosal eosinophils in 66% of patients (35% for placebo) and basophils in 39% of patients (28% for placebo). The direct relationship of these findings to long-term symptom relief is not known.

📦 How Supplied / Storage and Handling 161 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Propionate Nasal Spray USP, 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter fitted with a clear plastic dust cap, and a green safety clip, in a box of one with FDA-approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 16 g and will provide 120 actuations. Each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter.

The correct amount of medication in each spray cannot be assured after 120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used. NDC: 70518-0880-00 PACKAGING: 1 in 1 CARTON, TYPE 2 Store between 4° and 30°C (39° and 86°F).

Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

📋 Description 160 words ▾

11 DESCRIPTION The active component of fluticasone propionate nasal spray USP is fluticasone propionate USP, a corticosteroid having the chemical name S -(fluoromethyl)6α,9-difluoro-11β-17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure: Fluticasone propionate is a white to off-white powder with a molecular weight of 500.6 and the molecular formula is C 25 H 31 F 3 O 5 S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol.

Fluticasone propionate nasal spray, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. Fluticasone propionate nasal spray also contains 0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol and polysorbate 80 and has a pH between 5 and 7. After initial priming, each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. structural formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Local Nasal Effects : Inform patients that treatment with fluticasone propionate nasal spray may lead to adverse reactions, which include epistaxis and nasal ulceration. Candida infection may also occur with treatment with fluticasone propionate nasal spray.

In addition, fluticasone propionate nasal spray has been associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should not use fluticasone propionate nasal spray until healing has occurred [see Warnings and Precautions (5.1)] . Glaucoma and Cataracts : Inform patients that glaucoma and cataracts are associated with nasal and inhaled corticosteroid use.

Advise patients to notify their healthcare providers if a change in vision is noted while using fluticasone propionate nasal spray [see Warnings and Precautions (5.2)] . Hypersensitivity Reactions, including Anaphylaxis : Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, contact dermatitis, and rash, may occur after administration of fluticasone propionate nasal spray. If such reactions occur, patients should discontinue use of fluticasone propionate nasal spray [see Warnings and Precautions (5.3)].

Immunosuppression : Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and if they are exposed to consult their healthcare provider without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex [see Warnings and Precautions (5.4)] . Reduced Growth Velocity : Advise parents that fluticasone propionate nasal spray may cause a reduction in growth velocity when administered to pediatric patients.

Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route [see Warnings and Precautions (5.7), Pediatric Use (8.4)] . Use Daily for Best Effect : Inform patients that they should use fluticasone propionate nasal spray on a regular basis. Fluticasone propionate nasal spray, like other corticosteroids, does not have an immediate effect on rhinitis symptoms.

Maximum benefit may not be reached for several days. Patients should not increase the prescribed dosage but should contact their healthcare providers if symptoms do not improve or if the condition worsens. Keep Spray Out of Eyes and Mouth : Inform patients to avoid spraying fluticasone propionate nasal spray in their eyes and mouth.

Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 10002064/08 Revised March 2016

Patient Information Fluticasone Propionate Nasal Spray USP, 50 mcg (FLOO-tih-kah-sone) Read the Patient Information that comes with fluticasone propionate nasal spray before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is fluticasone propionate nasal spray? Fluticasone propionate nasal spray is a prescription medicine used to treat non-allergy nasal symptoms such as runny nose, stuffy nose, sneezing, and nasal itching in adults and children aged 4 years and older. It is not known if fluticasone propionate nasal spray is safe and effective in children younger than 4 years of age.

Who should not use fluticasone propionate nasal spray? Do not use fluticasone propionate nasal spray if you are allergic to fluticasone propionate or any of the ingredients in fluticasone propionate nasal spray. See “What are the ingredients in fluticasone propionate nasal spray?” below for a complete list of ingredients.

What should I tell my healthcare provider before using fluticasone propionate nasal spray? Tell your healthcare provider about…

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