Home › NDC Lookup › Ingredients › Helium › 46123-0800-02
Helium 990 mL/L Gas, 374 l — NDC 46123-0800-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Helium 990 mL/L Gas, 374 l — NDC 46123-800-02 (Billing 46123-0800-02)

by Roberts Oxygen Company, Inc. · 374 L in 1 CYLINDER

This is a package of 374 l of Helium 990 mL/L Gas from Roberts Oxygen Company, Inc., marketed since Jan 1967 and currently FDA-listed.

NDC 46123-0800-02
🏷️ FDA NDC (as labeled) 46123-800-02 billing pads the product segment with a zero
This package
Contains374 l Pack sizes7 compare ↓
Product page 46123-0800-01 Also comes in: 102 l 46123-800-01 623 l 46123-800-03 3880 l 46123-800-04 5436 l 46123-800-05 6910 l 46123-800-06 8241 l 46123-800-07
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 46123-800-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
46123 labeler · 800 product · 02 package
Package marketed since
Jan 1, 1967
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4612380002 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 46123-800-02
Product NDC 46123-800
11-digit billing NDC 46123080002
RxCUI 310693
UNII 206GF3GB41
Application # NDA213609
SPL Set ID 554faa48-7fc2-4d1a-b223-82cf107b144f
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1967-01-01
Route RESPIRATORY (INHALATION)
Dosage form GAS
Substance HELIUM
Quick answers
  • RxCUI (RxNorm): 310693
Why two NDCs? The FDA registers this code as 46123-800-02 — 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 → 46123-0800-02. 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

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: 102 l 623 l 3880 l 5436 l 6910 l 8241 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
46123-0800-01 46123-800-01 Main listing 102 L in 1 CYLINDER 1967-01-01 — Active
46123-0800-02 You're viewing this 374 L in 1 CYLINDER 1967-01-01 — Active
46123-0800-03 46123-800-03 623 L in 1 CYLINDER 1967-01-01 — Active
46123-0800-04 46123-800-04 3880 L in 1 CYLINDER 1967-01-01 — Active
46123-0800-05 46123-800-05 5436 L in 1 CYLINDER 1967-01-01 — Active
46123-0800-06 46123-800-06 6910 L in 1 CYLINDER 1967-01-01 — Active
46123-0800-07 46123-800-07 8241 L in 1 CYLINDER 1967-01-01 — Active

You're viewing one of 7 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 374 l — 374 l in 1 cylinder.
How does this package differ from NDC 46123-0800-01?
Both are Helium 990 mL/L Gas — the drug itself is identical. This page's package is the 374 l one, while NDC 46123-0800-01 is the 102 l package.
What NDC number is used to bill for this package of Helium 990 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
Helium 990 mL/L 10014-0004-10 Aero 623 l — — FDA listed —
Helium 99 L/100L 10167-0300-01 Air 610 l — — FDA listed —
Helium 990 mL/L 10297-0006-01 A-OX 85 l — — FDA listed —
Helium 990 mL/L 14961-0005-01 Haun 73 l — — FDA listed —
Helium 990 mL/L 17575-0005-01 AGL 7986 l — — FDA listed —
Helium 990 mL/L 21220-0200-01 General 6201 l — — FDA listed —
Helium 99 L/100L 42602-0002-01 Norco, 595 l — — FDA listed —
Helium 990 mL/Lthis 46123-0800-02 Roberts 374 l — — FDA listed —
Helium 990 mL/L 48273-0011-01 Keen 424.75 l — — FDA listed —
Helium 990 mL/L 49575-0200-06 Machine 99.5 l — — FDA listed —
Helium 990 mL/L 51486-0020-01 ILMO 144.4 l — — FDA listed —
Helium 990 mL/L 59579-0005-01 Linde 14696 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

🏛️
1967
On the market since
Jan 1967
📍
2026
Currently FDA-listed
59 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerRoberts Oxygen Company, Inc.
FDA applicationNDA213609 (NDA)
Labeler code46123
First marketedJan 1967
Product typeHuman Prescription Drug
Portfolio42 products on file

More NDCs from Roberts Oxygen Company, Inc. labeler code 46123

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 192 words ▾

HELIUM, COMPRESSED USP UN1046 NON-FLAMMABLE GAS 2 Rx ONLY. WARNING: Administration of Helium USP 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 Helium USP and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and the hazards, contraindications and side effects and the precautions to be taken.

WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood.

Use and store only outdoors or in a well-ventilated place. Use a back flow preventative 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 52ºC (125ºF). Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention. CAS: 7440-59-7 DO NOT REMOVE THIS PRODUCT LABEL.

Roberts Oxygen Company, Inc. PO BOX 5507 Rockville, MD 20855 301-948-8100 image of cylinder label

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Roberts Oxygen Company, Inc.. 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 6 other package presentations of this same product, including 102 l (46123-0800-01), 623 l (46123-0800-03), 3880 l (46123-0800-04). 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?
Roberts Oxygen Company, 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.
← 46123-0700-01 · Roberts 46123-0911-01 · Roberts →
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.