OXYGEN 99.5 L/100L Gas, 235 l
by Alternacare Home Health Services · 235 L in 1 CYLINDER (64097-0001-2)
NDC 64097-0001-02
🏷️ FDA NDC (as labeled)
64097-0001-2
billing pads the package segment with a zero
This package
Contains235 l
Pack sizes4 compare ↓
Rx only
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
64097-0001-2
Product NDC
64097-0001
11-digit billing NDC
64097000102
RxCUI
312173
UNII
S88TT14065
SPL Set ID
b5411c07-aa69-4760-b353-3c4b5beba506
DEA schedule
Non-controlled
Marketing category
UNAPPROVED MEDICAL GAS
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1996-01-01
Route
RESPIRATORY (INHALATION)
Dosage form
GAS
Substance
OXYGEN
Why two NDCs?
The FDA registers this code as 64097-0001-2 — 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 → 64097-0001-02. 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.
🏭 Manufacturer & labeler
LabelerAlternacare Home Health Services
Labeler code64097
First marketedJan 1996
Product typeHuman Prescription Drug
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
📗 Our plain-language guide HelloPharmacist
📖 Read our full Oxygen guide →
Patient education
Supplement & herbal interactions
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.
💬 Questions about OXYGEN?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💲 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 system | Per each | Per 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
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Oxygen 995 mL/L 10218-0001-01 | CEE-KAY | 8500 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 10297-0100-01 | A-OX | 8070 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 10304-0463-01 | Delille | 141867 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 10690-0001-01 | Depke | 163 l | — | — | Discontinued | — |
| Oxygen 995 mL/L 20703-0002-01 | General | 9543 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 21220-0119-01 | General | 8778 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 21221-0002-01 | General | 167919 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 21624-0001-11 | Island | 179 l | — | — | Discontinued | — |
| Oxygen 995 mL/L 23647-0001-01 | SYOXSA, | 9310 l | — | — | Discontinued | — |
| Oxygen 995 mL/L 42241-0001-01 | - | 198 l | — | — | FDA listed | — |
| Oxygen 99.5 L/100L 48546-0002-01 | Indiana | 6228 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 50063-0001-01 | Andy-Oxy | 368 l | — | — | FDA listed | — |
| Oxygen Compressed U.S.P .995 mL/L 51319-0072-01 | Apria | 164 l | — | — | FDA listed | — |
| Oxygen Refrigerated Liquid U.S.P .995 mL/L 51319-0073-01 | Apria | 10 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 52003-0011-20 | Messer | 18144 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 52374-0011-20 | Messer | 18144 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 52438-0011-20 | Messer | 18144 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 52695-0001-01 | Humphries, | 7107 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 53425-0001-01 | IWS | 7108 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 53440-0001-01 | Westair | 230 l | — | — | Discontinued | — |
| Air 995 mL/L 53440-0007-01 | Westair | 33980 l | — | — | Discontinued | — |
| Oxygen 995 mL/L 53991-0001-01 | Southern | 198 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 54244-0001-01 | CONROE | 240 l | — | — | FDA listed | — |
| Oxygen .995 L/L 54316-0123-01 | Youngstown | 425 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 54528-0001-01 | Commonwealth | 165 l | — | — | FDA listed | — |
| oxygen 995 mL/L 54767-0001-09 | Shaw | 424 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 58404-0001-01 | Industrial | 198 l | — | — | FDA listed | — |
| Oxygen 99.5 L/100L 58987-0001-01 | Enos | 113 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 59378-0001-01 | Jayco | 198 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 59788-0001-10 | Arcet | 103 l | — | — | FDA listed | — |
| Oxygen Compressed Gas 995 mL/L 62145-0002-01 | Dallas | 146 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 62273-0001-01 | Metro | 113 l | — | — | FDA listed | — |
| Oxygen 99.5 L/100Lthis 64097-0001-02 | Alternacare | 235 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 67573-0103-01 | B | 6270 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 67573-0104-07 | B | 420 l | — | — | FDA listed | — |
| Oxygen 99.5 L/100L 67932-1313-01 | Premier | 165 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 70101-0001-01 | Gas | 180 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 70975-0001-01 | Earlbeck | 7985 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 71654-0005-01 | SOUTHERN | 198 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 76349-0001-01 | Southern | 198 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 81734-0001-01 | CRYOGENIC | 679 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 82457-0004-01 | Toll | 180 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 82666-0001-01 | ABSOLUTE | 17033 l | — | — | FDA listed | — |
| Oxygen 995 mL/L 83746-0002-01 | Gas | 198 l | — | — | 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
🏛️
1996
On the market since
Jan 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.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Oxygen — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 65%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64097-0001-01 | 142 L in 1 CYLINDER (64097-0001-1) | 1996-01-01 | Active |
| 64097-0001-02 You're viewing this | 235 L in 1 CYLINDER (64097-0001-2) | 1996-01-01 | Active |
| 64097-0001-03 | 393 L in 1 CYLINDER (64097-0001-3) | 1996-01-01 | Active |
| 64097-0001-04 | 646 L in 1 CYLINDER (64097-0001-4) | 1996-01-01 | Active |
You're viewing one of 4 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 64097-0001-02?
NDC 64097-0001-02 contains 235 l — 235 l in 1 cylinder.
What is the difference between NDC 64097-0001-02 and NDC 64097-0001-01?
Both are OXYGEN 99.5 L/100L Gas — the drug itself is identical. NDC 64097-0001-02 is the 235 l package, while NDC 64097-0001-01 is the 142 l package.
What NDC number is used to bill for this package of OXYGEN 99.5 L/100L Gas?
Bill NDC 64097-0001-02 — the 11-digit billing format is 64097000102. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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) | — 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
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 Medical Gas". 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 FDA registers it as 64097-0001-2, 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: 64097-0001-02, written without dashes as 64097000102. 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 64097-0001-02, the first segment (64097) is the labeler code FDA assigned to Alternacare Home Health Services; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alternacare Home Health Services. 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 3 other package presentations of this same product, including 142 l (64097-0001-01), 393 l (64097-0001-03), 646 l (64097-0001-04). 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?
Alternacare Home Health Services 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.
⚠️ Warnings and Cautions ▾
WARNING: HIGH PRESSURE GAS CYLINDER Improper filling or abuse of this cylinder, or failure to heed this warning may cause serious injury or loss of life. DO NOT ALTER OR MODIFY CYLINDER OR RELATED COMPONENTS. DO NOT OVER PRESSURIZE.
Keep out of the reach of children. Cylinders that have been refinished and/or exposed to elevated temperatures must be hydrostatically tested before filling. Do not use caustic paint strippers.
Aluminum cylinders subject to action of fire or heated to temperatures in excess of 350 F must be withdrawn from service and condemned. Valves and safety relief devices must be removed and replaced by trained personnel. Do not alter or change safety discs.
Replace pressure relief devices only with complete assemblies supplied by the valve manufacturer. DO NOT FILL WITH OXIDIZING GASES WITHOUT PROPER CLEANING. Cylinders, valves and assemblies must be specially cleaned for oxygen.
Verify cylinder content and pressure monthly, or more frequently if required. Store and use with adequate ventilation.
⚠️ Warnings ▾
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications Rx ONLY. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful.
Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. WARNING: HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATED COMBUSTION Use only with pressure reducing equipment and apparatus cleaned and designed for oxygen service and rated for cylinder pressure. Open valve slowly.
Close valve after each use and when empty. Keep cylinder, cylinder valve, all equipment that connects, free of oil and grease to avoid violent ignition. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance wiith the Federal Food, Drug, and Cosmetic Act.
Pursuant to recommendations by Compressed Gas Association, do not expose pressurized cylinders to temperatures in excess of 125 F DO NOT REMOVE THIS PRODUCT LABEL Use a back flow preventative device in the piping. Use only in accordance with product instructions and material safety data sheet.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.