Nitrogen
Nitrogen is an FDA drug label for the active ingredient NITROGEN manufactured by Linde Inc. administered by RESPIRATORY (INHALATION). This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260716.
- Generic name
- NITROGEN
- Manufacturer
- Linde Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- RESPIRATORY (INHALATION)
- Dosage form
- N/A
- NDC
- 59578-499
- Application
- NDA205850
- Label effective
- 20260716
About this product
Nitrogen is an FDA-registered drug product whose active ingredient is NITROGEN. It is labelled by Linde Inc. taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 59578-499, application NDA205850, label effective 20260716. It is one of 13 FDA drug label records sharing the active ingredient NITROGEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
More products with the same ingredient
NITROGENHow products containing NITROGEN compare
FDA lists 13 drug label records with NITROGEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | AIRGAS USA, LLC | 1 |
| — | — | Air Products and Chemicals, Inc. | 1 |
| — | — | Arcet Equipment Company dba Arc3 Gases North | 1 |
| — | — | Atlas Welding Supply Company, Inc. | 1 |
| — | — | General Welding Supply Corp. | 1 |
Recall and safety notices
2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0164-2025 | Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium Citrate Dihydrate - 2.6 mg; Mannitol - 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40 | Curium US, LLC | Class II | Terminated | 20250101 |
| D-0747-2022 | NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, kit contains Vial 1 (Reaction vial with lyophilized powder), 1 Single dose vial, consisting of 40 mcg of dotate, 5 mcg of 1,10-phenanthroline, 6 mcg of Gentisic acid, 20 mg of D-Mannitol, and Nitrogen; and Vial 2, 1 Single dose vial of reaction buffer, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc., by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40 | Advanced Accelerator Applications USA, Inc. | Class III | Terminated | 20220413 |
Frequently asked questions
What is Nitrogen used for?
No indications section is present in the FDA label on file for this product. Consult the prescribing information supplied with the medicine or ask a pharmacist.
Who makes Nitrogen?
Linde Inc. is the labeler of record for Nitrogen. 13 FDA label records share the active ingredient NITROGEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Nitrogen come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Nitrogen prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing NITROGEN?
Yes. 13 FDA drug label records list NITROGEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Nitrogen been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.