Label: NITROGEN gas
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NDC Code(s):
42751-1074-1,
42751-1074-2,
42751-1074-3,
42751-1074-4, view more42751-1074-5, 42751-1074-6, 42751-1074-7
- Packager: FULLERTON WELDING SUPPLY
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 14, 2022
If you are a consumer or patient please visit this version.
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PRINCIPAL DISPLAY PANEL
Certificate of Analysis
By Air-Liquefaction Process
Product: NITROGEN NF*
Manufacturing Plant: Pryor, OK
Address: Hwy 69A & 412 B
Pryor, OK 74361
Date / Time: 8/16/2018 9:43:00 AM
Lot Number: 037-08/16/2018/09:43
Delivery Unit # (Tanker / Railcar): 037
Quantity / Level / Prossure Gross: 31245 Tare: Net: LBS
*NF/EP applies only when used in a medical application or by medical customers properly registered with the FDA
Product delivered has been tested for indicated parameters and satisfies the contractually guaranteed purity specifications. Results are nominal values within statistical accuracy of analytical test methods.
This certificate does not add to or replace the warranty, limitations of liability or other provisions of the agreement between parties.
Requirement Test Method Specification Limit Result
Nitrogen Diff ≥ 99.999 percent ≥ 99.999 percent
Oxygen ** Delta F FAH0100 ≤ 5.00 ppm .68 ppm
Odor ** Organoleptic None None
Ppm = parts per million by volume ppb = parts per billion by volume
*Analysis on storage tank on periodic basis
**Analysis of each delivery unit
Released By:
Released via Electronic Signature: no handwritten signature required
(Signature)
Kevin N. Shue
(Printed Name)
QA-046US (08/17)
USJS0I00239193000 AutoLand TM
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INGREDIENTS AND APPEARANCE
NITROGEN
nitrogen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42751-1074 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGEN (UNII: N762921K75) (NITROGEN - UNII:N762921K75) NITROGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42751-1074-1 15 L in 1 DEWAR; Type 0: Not a Combination Product 08/30/2018 2 NDC:42751-1074-2 10 L in 1 DEWAR; Type 0: Not a Combination Product 08/30/2018 3 NDC:42751-1074-3 20 L in 1 DEWAR; Type 0: Not a Combination Product 08/30/2018 4 NDC:42751-1074-4 30 L in 1 DEWAR; Type 0: Not a Combination Product 08/30/2018 5 NDC:42751-1074-5 100 L in 1 DEWAR; Type 0: Not a Combination Product 08/30/2018 6 NDC:42751-1074-6 180 L in 1 DEWAR; Type 0: Not a Combination Product 08/30/2018 7 NDC:42751-1074-7 260 L in 1 DEWAR; Type 0: Not a Combination Product 08/30/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205866 08/30/2018 Labeler - FULLERTON WELDING SUPPLY (556832384) Establishment Name Address ID/FEI Business Operations FULLERTON WELDING SUPPLY 556832384 manufacture(42751-1074)