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Helium/Oxygen Mix 200 mL/L Gas, 382 l — NDC 12213-0801-13 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Helium/Oxygen Mix 200 mL/L Gas, 382 l — NDC 12213-801-13 (Billing 12213-0801-13)

by NEXAIR, LLC · 382 L in 1 CYLINDER

This is a package of 382 l of Helium/Oxygen Mix 200 mL/L Gas from NEXAIR, LLC, marketed since Jun 1996 and currently FDA-listed.

NDC 12213-0801-13
🏷️ FDA NDC (as labeled) 12213-801-13 billing pads the product segment with a zero
This package
Contains382 l Pack sizes8 compare ↓
Product page 12213-0801-01 Also comes in: 586 l 12213-801-04 5663 l 12213-801-12 5774 l 12213-801-02 5856 l 12213-801-05 5938 l 12213-801-06 5987.5 l 12213-801-01 6201 l 12213-801-03
Rx only Brand 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 12213-801-13 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
12213 labeler · 801 product · 13 package
Package marketed since
Jun 1, 1996
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1221380113 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 12213-801-13
Product NDC 12213-801
11-digit billing NDC 12213080113
RxCUI 413101
UNII S88TT14065
Application # NDA205849
SPL Set ID 60dd4f4b-7132-385e-e053-2a91aa0ad5d6
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-06-01
Route RESPIRATORY (INHALATION)
Dosage form GAS
Substance OXYGEN
Quick answers
  • RxCUI (RxNorm): 413101
Why two NDCs? The FDA registers this code as 12213-801-13 — 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 → 12213-0801-13. 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 Medical gases class.

Drug family (ATC) Medical gases
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

📗 Our plain-language guide HelloPharmacist
📖 Read our full Oxygen guide →

Supplement & herbal interactions

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

Pricing

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

Price systemPer 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.
Try another pack size: 586 l 5663 l 5774 l 5856 l 5938 l 5987.5 l 6201 l
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
12213-0801-01 12213-801-01 Main listing 5987.5 L in 1 CYLINDER 1996-06-01 — Active
12213-0801-02 12213-801-02 5774 L in 1 CYLINDER 1996-06-01 — Active
12213-0801-03 12213-801-03 6201 L in 1 CYLINDER 1996-06-01 — Active
12213-0801-04 12213-801-04 586 L in 1 CYLINDER 1996-06-01 — Active
12213-0801-05 12213-801-05 5856 L in 1 CYLINDER 1996-06-01 — Active
12213-0801-06 12213-801-06 5938 L in 1 CYLINDER 1996-06-01 — Active
12213-0801-12 12213-801-12 5663 L in 1 CYLINDER 1996-06-01 — Active
12213-0801-13 You're viewing this 382 L in 1 CYLINDER 1996-06-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 382 l — 382 l in 1 cylinder.
How does this package differ from NDC 12213-0801-04?
Both are Helium/Oxygen Mix 200 mL/L Gas — the drug itself is identical. This page's package is the 382 l one, while NDC 12213-0801-04 is the 586 l package.
What NDC number is used to bill for this package of Helium/Oxygen Mix 200 mL/L Gas?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Air Compressed 20 L/100L 10167-0600-01 Air 650 l — — FDA listed —
Heliox 200 mL/L 10297-0080-01 A-OX 637.13 l — — FDA listed —
Helium/Oxygen Mix 200 mL/Lthis 12213-0801-13 NEXAIR, 382 l — — FDA listed —
Oxygen Helium Mixture 20/80 200 mL/L 17575-0192-01 AGL 4554 l — — FDA listed —
Oxygen Nitrogen Mixture 200 mL/L 21220-0130-01 General 7107 l — — FDA listed —
Helium/Oxygen Mixture 80/20 200 mL/L 21220-0155-01 General 7108 l — — FDA listed —
Air 200 mL/L 51887-0502-01 Maine 8041 l — — FDA listed —
Air Compressed 20 L/100L 54218-0400-09 United 650 l — — FDA listed —
Heliox 200 mL/L 62273-0007-01 Metro 8495.05 l — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1996
On the market since
Jun 1996
📍
2026
Currently FDA-listed
30 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.

🧪 Avoiding an ingredient? See Oxygen inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 800 mL / 1 L UNII 206GF3GB41
    Helium is a colorless, odorless gas. It is occasionally used in pressurized inhalers and aerosol formulations as a propellant to help deliver the active medication to the lungs.

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

LabelerNEXAIR, LLC
FDA applicationNDA205849 (NDA)
Labeler code12213
First marketedJun 1996
Product typeHuman Prescription Drug
Portfolio9 products on file

More NDCs from NEXAIR, LLC labeler code 12213

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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel ~2 min read ▾

COMPRESSED GAS, N.O.S. (OXYGEN, HELIUM) UN1956 20% OXYGEN USP 80% HELIUM USP MIXTURE CAS: (7782-44-7) (7440-59-7) RX Only WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken.

WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Avoid breathing gas.

Use and store only outdoors or in well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for cylinder pressure.

Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID: IF ACCIDENTALLY INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. NET CONTENTS Cylinder Size Cubic Feet Liters (Gaseous) K 200.4 5675 E 22.0 625 D-puritan 13.5 382 DO NOT REMOVE THIS PRODICT LABEL.

Distributed by nexAir nexAir, LLC www.nexAir.com 1350 Concourse Ave., Suite 103 Memphis, TN 38104 888-639-2474 helium oxygen mix

COMPRESSED GAS, OXIDIZING, N.O.S. (HELIUM, OXYGEN) UN3156 % OXYGEN USP % HELIUM USP MIXTURE CAS: (7782-44-7) (7440-59-7) RX Only. WARNING: Administration of this gas mixture may be hazardous or contraindicated.

For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures, and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.

Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil.

Use and store only outdoors or in well-ventilated place. Use a back flow preventive device in the piping. Use only with equipment rated for oxygen service.

Open valve slowly. In case of fire: stop leak if safe to do so. Close valve after each use and when empty.

Protect from sunlight when ambient temperature exceeds 52 C (125 F). Read and follow the Safety Data Sheet (SDS) before use. DO NOT REMOVE THIS PRODICT LABEL.

Net Contents Cubic Feet Liters Distributed by nexAir nexAir, LLC www.nexAir.com 1350 Concourse Ave., Suite 103 Memphis, TN 38104 888-639-2474 helium oxygen mix two

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
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

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 NEXAIR, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 7 other package presentations of this same product, including 586 l (12213-0801-04), 5663 l (12213-0801-12), 5774 l (12213-0801-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
NEXAIR, LLC 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.
← 12213-0800-01 · NEXAIR, 12213-0900-11 · NexAir, →
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.