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Amyl Nitrite .3 g/.3mL Inhalant, 144 ampules — NDC 46414-2222-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Amyl Nitrite .3 g/.3mL Inhalant, 144 ampules — NDC 46414-2222-8 (Billing 46414-2222-08)

by James Alexander Corporation · 144 AMPULE in 1 CARTON / .3 mL in 1 AMPULE

This is a package of 144 ampules of Amyl Nitrite .3 g/.3mL Inhalant from James Alexander Corporation, marketed since Feb 1979 and currently FDA-listed. It is this product's only package size.

NDC 46414-2222-08
🏷️ FDA NDC (as labeled) 46414-2222-8 billing pads the package segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 46414-2222-8 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
46414 labeler · 2222 product · 8 package
Package marketed since
Feb 7, 1979
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4641422228 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 46414-2222-8
Product NDC 46414-2222
11-digit billing NDC 46414222208
RxCUI 577307
UNII 22T8Z09XAK
SPL Set ID c1b6e536-df5f-4f76-8e3c-6dc2f1e9975e
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1979-02-07
Route RESPIRATORY (INHALATION)
Dosage form INHALANT
Substance AMYL NITRITE
Quick answers
  • RxCUI (RxNorm): 577307
Why two NDCs? The FDA registers this code as 46414-2222-8 — 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 → 46414-2222-08. 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 Antidotes class.

Drug family (ATC) Antidotes
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

This is an unapproved prescription inhalant containing amyl nitrite, a volatile liquid meant to be inhaled through the nose. Amyl nitrite is a vasodilator, a type of substance that relaxes blood vessels and is typically used to lower blood pressure quickly in certain medical situations. This product is not approved by the FDA and is marketed outside the standard drug approval process.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
46414-2222-08 You're viewing this Main listing 144 AMPULE in 1 CARTON / .3 mL in 1 AMPULE 1979-02-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Amyl Nitrite .3 g/.3mLthis 46414-2222-08 James 144 ampules — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
1979
On the market since
Feb 1979
📍
2026
Currently FDA-listed
47 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

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

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

  • UNII 84XB4DV00W
    Linseed oil is a plant-based oil extracted from flax seeds. It's used in medicines as an emollient and lubricant to improve texture and help with ingredient mixing in formulations.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerJames Alexander Corporation
Labeler code46414
First marketedFeb 1979
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from James Alexander Corporation labeler code 46414

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 ⚠️ Precautions 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE: Amyl nitrite is indicated for the rapid relief of angina pectoris. Its effect appears within 30 seconds and lasts for approximately 3 to 5 minutes.

⏱️ Dosage and Administration 84 words ▾

DOSAGE & ADMINISTRATION: With the patient in recumbent or seated position a capsule of amyl nitrite is held away from the face, crushed between the fingers, and held under the patient's nose. Two to six inhalations of the vapors from the capsule are usually sufficient to promptly produce therapeutic effects. Caution is recommended to avoid inhalation of excessive amounts of the drug when it is administered by someone other than the patient.

If necessary, the dose may be repeated in 3 to 5 minutes.

⛔ Contraindications 63 words ▾

CONTRAINDICATIONS: Since it may increase intraocular and intracranial pressures, amyl nitrite is contraindicated or should be used with great caution in patients with glaucoma, recent head trauma or cerebral hemorrhage. Amyl nitrite can cause harm to the fetus when it is administered to a pregnant woman because it significantly reduces systemic blood pressure and blood flow on the maternal side of the placenta.

⚠️ Warnings 54 words ▾

WARNINGS: Transient episodes of dizziness, weakness, or syncope or other signs of cerebral ischemia due to postural hypotension may develop following inhalation of amyl nitrite, particularly if the patient is standing immobile. To hasten recovery, measures which facilitate venous return such as head low posture, deep breathing and movement of extremities may be used.

🤒 Adverse Reactions 56 words ▾

ADVERSE REACTIONS: Mild transitory headache, dizziness and flushing of the face are common with the use of amyl nitrite. The following adverse reactions may occur in susceptible patients: syncope, involuntary passing of urine and feces, hypotension, pallor, cold sweat, tachycardia, restlessness, weakness, vomiting and nausea. Excessively high doses of amyl nitrite administered chronically may cause methemoglobinemia.

🆘 Overdosage 141 words ▾

OVERDOSAGE: Symptoms - Inhaled doses of 5 to 10 drops of amyl nitrite may cause violent flushing of the face, accompanied by a feeling of imminent bursting of the head and very excessive heart action. The inhalation of larger amounts may produce a feeling of suffocation and muscular weakness. Symptoms comparable to shock may be produced (such as weakness, restlessness, sweating, pallor, nausea, vomiting, syncope and incontinence) attributable to pooling of blood in the postarteriolar vessels and failure of the venous blood to return to the heart.

Treatment - Measures which facilitate venous return such as head-low posture, deep breathing and movement of extremities may be used. The use of epinephrine aggravates the shock- like reaction. Methylene blue should be injected for treatment of severe methemoglobinemia with dyspnea.

For treating cyanide poisoning, methylene blue is contraindicated where nitrites cause iatrogenic methemoglobinemia.

🧬 Clinical Pharmacology 102 words ▾

CLINICAL PHARMACOLOGY: Amyl nitrite causes a non specific relaxation of smooth muscle with the most prominent actions occurring in vascular smooth muscle. This effect on vascular smooth muscle results in coronary vasodilation and decreased systemic vascular resistance and left ventricular preload and afterload. Myocardial ischemia is relieved in patients with angina pectoris, with an abatement of chest pain and possibly other related symptoms.

Amyl nitrite vapors are absorbed rapidly through the pulmonary alveoli, manifesting therapeutic effects within one minute after inhalation. The drug is metabolized rapidly, probably by hydrolytic denitration; approximately one-third of the inhaled amyl nitrite is excreted in the urine.

📦 How Supplied / Storage and Handling 65 words ▾

HOW SUPPLIED: JAMES ALEXANDER brand amyl nitrite is furnished in covered glass capsules. Each capsule contains 0.3 mL in boxes of 12. Capsule contents are FLAMMABLE and should be protected from light. Storage should be in a cold place. 2 o - 8 o C (36 o - 46 o F) The James Alexander Corporation Blairstown, New Jersey 07825. Rev. 03 July 2012 Rx only.

📋 Description 74 words ▾

DESCRIPTION: Amyl nitrite is a rapidly acting vasodilator administered by inhalation. 0.3mL is supplied in a covered thin glass capsule which is easily crushed between the fingers. Amyl nitrite is a clear, yellowish liquid having a peculiar ethereal, fruity odor. It is volatile, even at low temperatures, and is flammable. This product is stabilized with Linseed Oil Epoxy. The structural formula of amyl nitrite is: (CH 3 ) 2 CHCH 2 CH 2 ONO

⚠️ Precautions ~1 min read ▾

CAUTION : Amyl nitrite is very flammable. Do not use where it might become ignited. Keep away from open flame or sparks.

PRECAUTIONS : Genera l - Tolerance to amyl nitrite may develop with repeated use of the drug for prolonged periods of time. Tolerance may be minimized by beginning with the smallest effective dose and alternating the drug with another coronary vasodilator. High doses of nitrites may produce methemoglobinemia, especially in individuals with methemoglobin reductase deficiency or other metabolic abnormality that interferes with the normal conversion of methemoglobin back to haemoglobin.

Patient Information - Amyl nitrite should be taken by the patient when seated or lying down. Drug Interactions - Taking amyl nitrite after drinking alcohol may worsen side effects and may cause severe hypotension and cardiovascular collapse. Carcinogenesis, Mutagenesis, Fertility Impairment - Adequate long term studies to establish adverse carcinogenic potential of this drug have not been reported.

Pregnancy - Teratogenic effects: Category C. Animal studies have not been conducted with amyl nitrite. It is also not known whether amyl nitrite can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Amyl nitrite should be given to a pregnant woman only if clearly needed. Nursing Mothers - It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when amyl nitrite is administered to a nursing woman.

Pediatric Use - Safety and effectiveness in children have not been established.

🔒 Drug Abuse and Dependence 34 words ▾

DRUG ABUSE AND DEPENDENCE: Abuse - Volatile nitrites are abused for sexual stimulation, with headache as a common side effect. Dependence - Tolerance to nitrites can develop; conditions and duration have not been established.

📄 Package Label / Principal Display Panel 12 words ▾

Packaging image description

Packaging image description

Packaging image description

Insert image description

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

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by James Alexander Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
James Alexander Corporation 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.
← 46414-2040-03 · James 46414-3333-02 · James →
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.