FDA.reportPublic FDA data

Nitrous Oxide

Product NDC
48883-004
11-digit product format
488830004
Labeler code
48883
Product ID
48883-004_ef3b5bcc-51d6-4ec8-8f5d-d5b8ff7fbba5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrous Oxide
Dosage form
GAS
Route
RECTAL
Labeler
Encompass Medical & Specialty Gases, Ltd.
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2008-01-02
Marketing end
0000-00-00
Substance
NITROUS OXIDE
Active strength
990 mL/L
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48883-004-012019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-022019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-032019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-042019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-052019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-062019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-072019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-082019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-092019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-102019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label
48883-004-112019-10-29C16284748780-1960f7f55-d0c1-8e05-e053-dbdaa90a074aNitrous Oxide Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48883-004-01Nitrous Oxide148 L in 1 CYLINDERGAS1481
48883-004-02Nitrous Oxide936 L in 1 CYLINDERGAS9361
48883-004-03Nitrous Oxide991 L in 1 CYLINDERGAS9911
48883-004-04Nitrous Oxide1577 L in 1 CYLINDERGAS15771
48883-004-05Nitrous Oxide1726 L in 1 CYLINDERGAS17261
48883-004-06Nitrous Oxide2464 L in 1 CYLINDERGAS24641
48883-004-07Nitrous Oxide4927 L in 1 CYLINDERGAS49271
48883-004-08Nitrous Oxide7386 L in 1 CYLINDERGAS73861
48883-004-09Nitrous Oxide7391 L in 1 CYLINDERGAS73911
48883-004-10Nitrous Oxide12318 L in 1 DEWARGAS123181
48883-004-11Nitrous Oxide13810 L in 1 DEWARGAS138101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nitrous OxideACTIVE INGREDIENTK50XQU1029NITROUS OXIDE GAS [ENCOMPASS MEDICAL & SPECIALTY GASES, LTD.]1
Nitrous OxideACTIVE MOIETYK50XQU1029NITROUS OXIDE GAS [ENCOMPASS MEDICAL & SPECIALTY GASES, LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48883-004NITROUS OXIDE GAS [ENCOMPASS MEDICAL & SPECIALTY GASES, LTD.]1Legacy NDC, 11 package rows20101220_ffcfc7c1-5806-4f37-9a0f-f64cb06410e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
48883-004-0148883000401148 L in 1 CYLINDER148 lHistorical
48883-004-0248883000402936 L in 1 CYLINDER936 lHistorical
48883-004-0348883000403991 L in 1 CYLINDER991 lHistorical
48883-004-04488830004041577 L in 1 CYLINDER1577 lHistorical
48883-004-05488830004051726 L in 1 CYLINDER1726 lHistorical
48883-004-06488830004062464 L in 1 CYLINDER2464 lHistorical
48883-004-07488830004074927 L in 1 CYLINDER4927 lHistorical
48883-004-08488830004087386 L in 1 CYLINDER7386 lHistorical
48883-004-09488830004097391 L in 1 CYLINDER7391 lHistorical
48883-004-104888300041012318 L in 1 DEWAR12318 lHistorical
48883-004-114888300041113810 L in 1 DEWAR13810 lHistorical