Label: NITROGEN- nitrogen gas
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- NDC Code(s): 52438-016-20
- Packager: Messer LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 11, 2022
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- WARNINGS SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Messer
Gases for Life
Certicate of Analysis - Nitrogen NF
Product: Nitrogen NF
Date
Facility Name
Facility Address
Lot#
Batch #
Final Analysis Results
Analyzer #
Test/Units
NF Specs
Analysis Results
N/A
Odor
None
ppm O2
< 10,000
(Messer Spec <5.0)
ppm
ppm CO
< 10.0
ppm
ppm THC
N/A
ppm
ppm H2O
N/A
ppm
ppm CO2
N/A
ppm
ppm H2
N/A
ppm
Assay Results
Nitrogen min %
> 99.0%
(Messer Spec >99.999%)
%
NT= not tested
PPM O2 Method Used: __________________________
Manufacturer/
Model #: __________________________
PPM O2 Method Used:
__________________________
Manufacturer/Model #: __________________________
This analyzer has been validated by Messer as acceptable alternatives to the official NF for Nitrogen Assay. Validation study documentation is maintained by Messer at the corporate offices.
Analyst
Date
Quality Reviewer
Date
Should the material not be delivered to a NF customer, the material is “Not Approved for Human Drug Use.”
2.5 January 2019
ASU-22-06-GAM-Medical Gas Procedures
Page 1 of 1
Retention Period – 3 Years
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INGREDIENTS AND APPEARANCE
NITROGEN
nitrogen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52438-016 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nitrogen (UNII: N762921K75) (Nitrogen - UNII:N762921K75) Nitrogen 995 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52438-016-20 25000 L in 1 TANK; Type 0: Not a Combination Product 01/01/1960 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205766 01/01/1960 Labeler - Messer LLC (001368141) Registrant - Messer LLC (001368141) Establishment Name Address ID/FEI Business Operations Messer LLC 943812438 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 026946218 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 041268947 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 101889988 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 003000197 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 081695020 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 872699181 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 002123321 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 092191712 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 839692303 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 791242337 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 192602431 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 945417111 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 042263707 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 147344667 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 102835006 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 940070527 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 969312248 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 004212362 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 019983468 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 799311001 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 079481211 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 809794592 manufacture(52438-016) , api manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 108034669 api manufacture(52438-016) , manufacture(52438-016) Establishment Name Address ID/FEI Business Operations Messer LLC 093220150 manufacture(52438-016) , api manufacture(52438-016)