Nitrous Oxide
Medical-technical Gases, Inc.
Human Prescription Drug
NDC 10736-017Nitrous Oxide is a human prescription drug labeled by 'Medical-technical Gases, Inc.'. National Drug Code (NDC) number for Nitrous Oxide is 10736-017. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Nitrous Oxide drug includes Nitrous Oxide - 995 mL/L . The currest status of Nitrous Oxide drug is Active.
Drug Information:
| Drug NDC: | 10736-017 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Nitrous Oxide |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Nitrous Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medical-technical Gases, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gas |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | NITROUS OXIDE - 995 mL/L
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | RESPIRATORY (INHALATION)
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jan, 1963 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA209989 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | MEDICAL-TECHNICAL GASES, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 347046
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | K50XQU1029
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 10736-017-01 | 988 L in 1 CYLINDER (10736-017-01) | 01 Jan, 1963 | N/A | No |
| 10736-017-02 | 1606 L in 1 CYLINDER (10736-017-02) | 01 Jan, 1963 | N/A | No |
| 10736-017-03 | 2379 L in 1 CYLINDER (10736-017-03) | 01 Jan, 1963 | N/A | No |
| 10736-017-04 | 3596 L in 1 CYLINDER (10736-017-04) | 01 Jan, 1963 | N/A | No |
| 10736-017-05 | 6909 L in 1 CYLINDER (10736-017-05) | 01 Jan, 1963 | N/A | No |
| 10736-017-06 | 9486 L in 1 CYLINDER (10736-017-06) | 01 Jan, 1963 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Nitrous oxide nitrous oxide nitrous oxide nitrous oxide
Package Label Principal Display Panel:
Do not remove this label nitrous oxide compressed usp un1070 cas no. 10024-97-2 n2o caution: federal law prohibits dispensing without prescription warning: high pressure oxidizing liquid and gas. vigorously accelerates combustion. can cause rapid suffocation. can cause anesthetic effects. may cause frostbite. warning: administration of nitrous oxide 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 nitrous oxide 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: inhalation of nitrous oxide without sufficient oxygen supply may be fatal or cause brain damage. release of nitrous oxide will dilute the oxygen percentage in the atmosphere. physiological responses due to nitrous oxide exposure and oxygen deficiency inhibit ability to safely respond when exposed to nitrous oxide concentration in excess of 10 percent. caution: avoid breathing gas. store and use with adequate ventilation. keep oil and grease away. do not get liquid in eyes, on skin or clothing. cylinder temperature should not exceed 125 f (52 c). use only with equipment cleaned for nitrous oxide and rated for cylinder pressure. open valve slowly. use in accordance with med-techâs materials safety data sheet. first aid: if inhaled, remove to fresh air. if not breathing, give artificial respiration. if breathing is difficult, give oxygen. call a physician. in case of frostbite, obtain immediate medical attention. medtech since 1961 medical-technical gases, inc. 20 hall street, medford, ma 02155 617-395-1946 fax 617-395-9098 nitrous oxide