Nitrous Oxide
Airgas Usa, Llc
Human Prescription Drug
NDC 11054-007Nitrous Oxide is a human prescription drug labeled by 'Airgas Usa, Llc'. National Drug Code (NDC) number for Nitrous Oxide is 11054-007. This drug is available in dosage form of Gas. The names of the active, medicinal ingredients in Nitrous Oxide drug includes Nitrous Oxide - 992 mL/L . The currest status of Nitrous Oxide drug is Active.
Drug Information:
| Drug NDC: | 11054-007 |
| 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: | Airgas Usa, Llc |
| 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 - 992 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: | 06 Nov, 1997 |
| 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: | NDA206009 |
| 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, 2024 |
| 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: | AIRGAS USA, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 347166
|
| 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 |
|---|
| 11054-007-01 | 185 L in 1 CYLINDER (11054-007-01) | 06 Nov, 1997 | N/A | No |
| 11054-007-02 | 370 L in 1 CYLINDER (11054-007-02) | 06 Nov, 1997 | N/A | No |
| 11054-007-03 | 940 L in 1 CYLINDER (11054-007-03) | 06 Nov, 1997 | N/A | No |
| 11054-007-04 | 1225 L in 1 CYLINDER (11054-007-04) | 06 Nov, 1997 | N/A | No |
| 11054-007-05 | 1590 L in 1 CYLINDER (11054-007-05) | 06 Nov, 1997 | N/A | No |
| 11054-007-06 | 2466 L in 1 CYLINDER (11054-007-06) | 06 Nov, 1997 | N/A | No |
| 11054-007-07 | 4930 L in 1 CYLINDER (11054-007-07) | 06 Nov, 1997 | N/A | No |
| 11054-007-08 | 7570 L in 1 CYLINDER (11054-007-08) | 06 Nov, 1997 | N/A | No |
| 11054-007-09 | 8524 L in 1 CYLINDER (11054-007-09) | 06 Nov, 1997 | N/A | No |
| 11054-007-10 | 12300 L in 1 CYLINDER (11054-007-10) | 06 Nov, 1997 | N/A | No |
| 11054-007-11 | 13800 L in 1 CYLINDER (11054-007-11) | 06 Nov, 1997 | N/A | No |
| 11054-007-12 | 15800 L in 1 CYLINDER (11054-007-12) | 06 Nov, 1997 | N/A | No |
| 11054-007-13 | 18578 L in 1 CYLINDER (11054-007-13) | 06 Nov, 1997 | N/A | No |
| 11054-007-14 | 95155 L in 1 CYLINDER (11054-007-14) | 06 Nov, 1997 | 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:
Nitrous oxide, refregerated liquid usp product label nitrous oxide, refregerated liquid usp un2201 non-flammable gas 2 oxidizer 5.1 danger: contains gas under pressure: may explode if heated. may displace oxygen and cause rapid suffication. may cause or intensify fire: oxidizer. contains refrigerated gas: may cause cryogenic burns or injury. may cause drowsiness or dizziness. do not breathe gas. do not get into eyes, on skin, or on clothing. keep valves and fittings free from grease and oil. use and store only outdoors or in a well ventilated place. avoid spills. do not walk or roll equipment over spills. open valve slowly. close valve after each use and when empty. use a back flow preventive device in the piping. do not handle until all safety precautions have been read and understood. wear cold insulating gloves/face shield/eye protection. do not drop. use a suitable hand truck for container movement. always keep container in upright position. do not change or force fit connections. use only with equipment cleaned for oxygen service. keep/store away from clothing and other combustible materials. in case of fire: stop leak if safe to do so. store locked up. read and follow the safety data sheet (sds) before use. first aid: if inhaled: remove to fresh air and keep comfortable for breathing. get medical advice/attention. if on skin: thaw frosted parts with lukewarm water. do not rub affected area. call a poison center or doctor/physician if feeling unwell. rx only 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 precautions to be taken. cas: 10024-97-2 warning: this product contains a chemical known to the state of california to cause birth defects or other reproductive harm. do not remove this product label airgas® healthcare an air liquide company airgas usa, llc radnor, pa 19087-5283 safety data sheets available at www.airgas.com 844066 (06/16) ag ref n2o2
Nitrous oxide, usp product label nitrous oxide, usp un1070 non-flammable gas 2 oxidizer 5.1 rx only. 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 precautions to be taken. danger: contains gas under pressure: may explode if heated. may displace oxygen and cause rapid suffication. may cause or intensify fire: oxidizer. may cause frostbite. may cause drowsiness or dizziness. do not breathe gas. do not get into eyes, on skin, or on clothing. keep valves and fittings free from grease and oil. use and store only outdoors or in a well ventilated place. protect from sunlight when the ambient temperature exceeds 52°c/125°f. open valve slowly. close valve after each use and when empty. use a back flow preventive device in the piping. do not handle until all safety precautions have been read and understood. use only with equipment of compatible materials of construction and rated for cylinder pressure. use only with equipment cleaned for oxygen service. keep/store away from clothing and other combustible materials. in case of fire: stop leak if safe to do so. store locked up. read and follow the safety data sheet (sds) before use. first aid: if inhaled: remove to fresh air and keep comfortable for breathing. call a poison center or doctor/physician if feeling unwell. if on skin: thaw frosted parts with lukewarm water. do not rub affected area. get immediate medical advice/attention. warning: this product contains a chemical known to the state of california to cause birth defects or other reproductive harm. do not remove this product label form 850400 (r 06/16) airgas® healthcare an air liquide company airgas usa, llc radnor, pa 19087-5283 safety data sheets available at www.airgas.com ag hp n2o2 body
Nitrous oxide usp product label nitrous oxide usp un1070 do not remove this product label non-flammable gas 2 oxidizr 5.1 834436 (07/16) danger: contains gas under pressure: may explode if heated. may displace oxygen and cause rapid suffication. may cause or intensify fire: oxidizer. may cause frostbite. may cause drowsiness or dizziness. do not breathe gas. do not get into eyes, on skin, or on clothing. keep valves and fittings free from grease and oil. use and store only outdoors or in a well ventilated place. protect from sunlight when the ambient temperature exceeds 52°c/125°f. open valve slowly. close valve after each use and when empty. use a back flow preventive device in the piping. do not handle until all safety precautions have been read and understood. use only with equipment of compatible materials of construction and rated for cylinder pressure. use only with equipment cleaned for oxygen service. keep/store away from clothing and other combustible materials. in case of fire: stop leak if safe to do so. store locked up. read and follow the safety data sheet (sds) before use. first aid: if inhaled: remove to fresh air and keep comfortable for breathing. call a poison center or doctor/physician if feeling unwell. if on skin: thaw frosted parts with lukewarm water. do not rub affected area. get immediate medical advice/attention. rx only. 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 precautions to be taken. warning: this product contains a chemical known to the state of california to cause birth defects or other reproductive harm. airgas® healthcare an air liquide company airgas usa, llc radnor, pa 19087-5283 safety data sheets available at www.airgas.com ag hp n2o2 sl