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FLUTICASONE 50 ug Spray, Metered, 120-count — NDC 61919-0611-01 package photo

FLUTICASONE 50 ug Spray, Metered, 120-count

by Direct RX · 120 SPRAY, METERED in 1 BOTTLE, GLASS (61919-611-01)
NDC 61919-0611-01
🏷️ FDA NDC (as labeled) 61919-611-01 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 61919-611-01
Product NDC 61919-611
11-digit billing NDC 61919061101
NCPDP billing unit GM — per gram (weight)
Application # ANDA076504
SPL Set ID ab7529ac-fa19-4be8-9906-8889fa3e8398
Established class (EPC) Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route NASAL
Dosage form SPRAY, METERED
Substance FLUTICASONE PROPIONATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61919-611-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61919-0611-01. 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.

🏭 Manufacturer & labeler

LabelerDirect RX
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA076504 (ANDA)
Labeler code61919
Product typeHuman Prescription Drug
Portfolio204 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

📖 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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • 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 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 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.

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.

💲 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 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 ug 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 —
Fluticasone 50 ugthis 61919-0611-01 Direct 120 sprays — AB Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61919-0611-01 You're viewing this 120 SPRAY, METERED in 1 BOTTLE, GLASS (61919-611-01) 2019-04-09 Inactivated by FDA

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 61919-611-01, 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: 61919-0611-01, written without dashes as 61919061101. 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 61919-0611-01, the first segment (61919) is the labeler code FDA assigned to Direct RX; the middle segment (0611) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Direct RX 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 58 words ▾

INDICATIONS & USAGE SECTION Fluticasone Propionate Nasal Spray, USP is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness of Fluticasone Propionate Nasal Spray, USP in children below 4 years of age have not been adequately established.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE & ADMINISTRATION SECTION Patients should use Fluticasone Propionate Nasal Spray, USP at regular intervals for optimal effect. Adults 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 dosage divided into 100 mcg given 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 dosage to 100 mcg (1 spray in each nostril) once daily for maintenance therapy. Some patients (12 years of age and older) with seasonal allergic rhinitis may find as-needed use of 200 mcg once daily effective for symptom control (see Clinical Trials ). Greater symptom control may be achieved with scheduled regular use.

Adolescents and Children (4 Years of Age and Older) Patients should be started with 100 mcg (1 spray in each nostril once daily). Patients not adequately responding to 100 mcg may use 200 mcg (2 sprays in each nostril). Once adequate control is achieved, the dosage should be decreased to 100 mcg (1 spray in each nostril) daily.

The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). (See Individualization of Dosage and Clinical Trials sections.) Fluticasone Propionate Nasal Spray, USP is not recommended for children under 4 years of age. Directions for Use Illustrated patient's instructions for proper use accompany each package of Fluticasone Propionate Nasal Spray, USP.

⛔ Contraindications 19 words ▾

CONTRAINDICATIONS SECTION Fluticasone Propionate Nasal Spray, USP is contraindicated in patients with a hypersensitivity to any of its ingredients.

⚠️ Warnings ~2 min read ▾

WARNINGS SECTION The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis. A drug interaction study in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations (see CLINICAL PHARMACOLOGY: Drug Interactions and PRECAUTIONS: Drug Interactions ). During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression.

Therefore, coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. 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 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 exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Avoid spraying in eyes.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS SECTION In controlled US studies, more than 3,300 patients with seasonal allergic, perennial allergic, or perennial nonallergic rhinitis received treatment with intranasal fluticasone propionate. In general, adverse reactions in clinical studies have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions were reported with approximately the same frequency by patients treated with the vehicle itself. The complaints did not usually interfere with treatment.

Less than 2% of patients in clinical trials discontinued because of adverse events; this rate was similar for vehicle placebo and active comparators. Systemic corticosteroid side effects were not reported during controlled clinical studies up to 6 months' duration with Fluticasone Propionate Nasal Spray, USP. If recommended doses are exceeded, however, or if individuals are particularly sensitive or taking Fluticasone Propionate Nasal Spray, USP in conjunction with administration of other corticosteroids, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.

The following incidence of common adverse reactions (>3%, where incidence in fluticasone propionate-treated subjects exceeded placebo) is based upon 7 controlled clinical trials in which 536 patients (57 girls and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) were treated with Fluticasone Propionate Nasal Spray, USP 200 mcg once daily over 2 to 4 weeks and 2 controlled clinical trials in which 246 patients (119 female and 127 male adolescents and adults) were treated with Fluticasone Propionate Nasal Spray, USP 200 mcg once daily over 6 months.

Also included in the table are adverse events from 2 studies in which 167 children (45 girls and 122 boys aged 4 to 11 years) were treated with Fluticasone Propionate Nasal Spray, USP 100 mcg once daily for 2 to 4 weeks. Overall Adverse Experiences With >3% Incidence on Fluticasone Propionate in Controlled Clinical Trials With Fluticasone Propionate Nasal Spray, USP in Patients ≥4 Years With Seasonal or Perennial Allergic Rhinitis Adverse Experience Vehicle Placebo (n = 758) % Fluticasone Propionate 100 mcg Once Daily (n = 167) % Fluticasone Propionate 200 mcg Once Daily (n = 782) % Headache 14.6 6.6

16.1Pharyngitis 7.2 6.0

7.8Epistaxis 5.4 6.0

6.9Nasal burning/nasal irritation 2.6 2.4

3.2Nausea/vomiting 2.0 4.8

2.6Asthma symptoms 2.9 7.2

3.3Cough 2.8 3.6

3.8Other adverse events that occurred in ≤3% but ≥1% of patients and that were more common with fluticasone propionate (with uncertain relationship to treatment) included: blood in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like symptoms, aches and pains, dizziness, bronchitis. Observed During Clinical Practice In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of intranasal fluticasone propionate in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

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: Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which in rare instances were severe. Ear, Nose, and Throat: Alteration or loss of sense of taste and/or smell and, rarely, nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, cough, hoarseness, and voice changes.

Eye: Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts. Cases of growth suppression have been reported for intranasal corticosteroids, including fluticasone propionate (see PRECAUTIONS: Pediatric Use ).

🆘 Overdosage 174 words ▾

OVERDOSAGE SECTION Chronic overdosage may result in signs/symptoms of hypercorticism (see PRECAUTIONS ). Intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate twice daily for 7 days to healthy human volunteers was well tolerated. 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 1 bottle of Fluticasone Propionate Nasal Spray, USP contains approximately 8 mg of fluticasone propionate.

The oral and subcutaneous median lethal doses in mice and rats were >1,000 mg/kg (>20,000 and >41,000 times, respectively, the maximum recommended daily intranasal dose in adults and >10,000 and >20,000 times, respectively, the maximum recommended daily intranasal dose in children on a mg/m2 basis).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY SECTION Mechanism of Action Fluticasone propionate is a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. In vitro dose response studies on a cloned human glucocorticoid receptor system involving binding and gene expression afforded 50% responses at 1.25 and 0.17 nM concentrations, respectively. Fluticasone propionate was 3-fold to 5-fold more potent than dexamethasone in these assays.

Data from the McKenzie vasoconstrictor assay in man also support its potent glucocorticoid activity. In preclinical studies, fluticasone propionate revealed progesterone-like activity similar to the natural hormone. However, the clinical significance of these findings in relation to the low plasma levels (see Pharmacokinetics ) is not known.

The precise mechanism through which fluticasone propionate affects allergic 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, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. In 7 trials in adults, Fluticasone Propionate Nasal Spray, USP has decreased nasal mucosal eosinophils in 66% (35% for placebo) of patients and basophils in 39% (28% for placebo) of patients.

The direct relationship of these findings to long-term symptom relief is not known. Fluticasone Propionate Nasal Spray, USP like other corticosteroids, is an agent that does not have an immediate effect on allergic symptoms. A decrease in nasal symptoms has been noted in some patients 12 hours after initial treatment with Fluticasone Propionate Nasal Spray, USP.

Maximum benefit may not be reached for several days. Similarly, when corticosteroids are discontinued, symptoms may not return for several days. PharmacokineticsAbsorption The activity of Fluticasone Propionate Nasal Spray, USP is due to the parent drug, fluticasone propionate.

Indirect calculations indicate that fluticasone propionate delivered by the intranasal route has an absolute bioavailability averaging less than 2%. After intranasal treatment of patients with allergic 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. Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration.

Studies using oral dosing of radiolabeled drug have demonstrated that fluticasone propionate is highly extracted from plasma and absorption is low. Oral bioavailability is negligible, and the majority of the circulating radioactivity is due to an inactive metabolite. 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 91% with no obvious concentration relationship. Fluticasone propionate is weakly and reversibly bound to erythrocytes and freely equilibrates between erythrocytes and plasma.

Fluticasone propionate is not significantly bound to human transcortin. Metabolism 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. The only circulating metabolite detected in man is the 17β-carboxylic acid derivative of fluticasone propionate, which is formed through the cytochrome P450 3A4 pathway.

This inactive 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 metabolites detected in vitro using cultured human hepatoma cells have not been d…

📦 How Supplied / Storage and Handling 119 words ▾

HOW SUPPLIED SECTION Fluticasone Propionate Nasal Spray, USP 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter, and transparent dust cap in a box of 1 (NDC 60432-264-15) with patient's instructions for use. 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. Store between 4° and 30°C (39° and 86°F).

📋 Description 210 words ▾

DESCRIPTION SECTION Fluticasone propionate, the active component of Fluticasone Propionate Nasal Spray, USP is a synthetic 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 C25H31F3O5S. 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, USP 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, USP also contains microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25% w/w phenylethyl alcohol, and has a pH between 5 and 7. It is necessary to prime the pump before first use or after a period of non-use (1 week or more).

After initial priming (6 actuations), each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. Each 16-g bottle of Fluticasone Propionate Nasal Spray, USP provides 120 metered sprays. After 120 metered sprays, the amount of fluticasone propionate delivered per actuation may not be consistent and the unit should be discarded. image description

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