NITROGEN by Air Liquide Large Industries U.S. LP NITROGEN- nitrogen gas

NITROGEN by

Drug Labeling and Warnings

NITROGEN by is a Prescription medication manufactured, distributed, or labeled by Air Liquide Large Industries U.S. LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Nitrogen N.F. COA

AIR LIQUIDE  NITROGEN N.F.        Form Number: 2A-ALL-QUA-0003-F

                                                            Revision:         0

                                                            Effective Date: 03/02/06

                                                            Page:               1/1

CERTIFICATE OF ANALYSIS

Air Liquide large Industries U.S. L.P. – Houston, TX 77056

PRODUCED BY AIR LIQUEFACTION

1.Location       Street Address1                                  2. Carrier ________________

Street Address 2

City, State Zip

3. Lot Number ______________________                4. Trailer No _____________

PRE-FILL REPORT                                                   FILL REPORT

5.Residual Assay        6. Odor                                    7. Trailer loaded with appropriate product per appropriate

   (≤10 ppm O2)                Detected                                 loading procedure by:

   _______ ppm              Yes    No                              Signature _________________________

   ________                    ________                             Date _____________________________

    Initial                            Initial

ANALYSIS REPORT

Test required               Method of Analysis                             Specifications                         Results

ASSAY AND               8.PARAMAGNETIC       ___               99.998% N2 Minimum*           10. ____%

IDENTIFICATION         MICROFUEL CELL    ___

                                  ELECTROCHEMICAL ___            

                                   CELL                                           10 ppm O2 Maximum             11. _____ppm

                                    9.Analyzer Tag Number        

                                    12.DETECTPR TUBE        ___          10 ppm CO Maximum          14. _____ppm

CARBON                         INFARED ANALYZER   ___              Expiration Date of Tube       15. ______

MONOXIDE                                                                         Lot Number of Tube            16. ______

                                    13. Analyzer Tag Number

ODOR                         Organoleptic (Nasal)                           None                                       17. ______

N.F. applies only when used in a medical application or by medical customers properly registered with the FDA.

* Plus inerts

18. Analyzed By         ________________________            Date ____________

19. Does this lot require additional testing?  ___ NO            ___ YES – attach page 2

20. SQCU Review/Release _______________________     Date ____________

MANDATORY FORM

User must assure that this revision of the form is current prior to use. Completed forms become permanent records subject to the record retention policy.

INGREDIENTS AND APPEARANCE

NITROGEN  
nitrogen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 11853-023
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75)	NITROGEN	99 L  in 100 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11853-023-60	25000 L in 1 TANK; Type 0: Not a Combination Product	01/01/1960
2	NDC: 11853-023-61	50000 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	NDA205738	01/01/1960

Labeler - Air Liquide Large Industries U.S. LP (180015062)

Registrant - Air Liquide Large Industries U.S. LP (180015062)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		791294122	manufacture(11853-023)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		832290014	manufacture(11853-023)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		831993303	manufacture(11853-023)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		047089305	manufacture(11853-023)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		111765132	manufacture(11853-023)

Establishment
Name	Address	ID/FEI	Business Operations
Air Liquide Large Industries U.S. LP		117158467	manufacture(11853-023)