Label: OXYGEN gas
-
NDC Code(s):
64203-020-01,
64203-020-02,
64203-020-03,
64203-020-04, view more64203-020-05, 64203-020-06
- Packager: New Schryver LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved medical gas
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated November 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
OXYGEN USP CERTIFICATE OF ANALLYSIS
BULK PRODUCT LOADING TAG OXYGEN PRODUCED BY AIR LIQUEFACTION PROCESS MEETS USP REQUIREMENTS
VESSEL/TANK#________________ QUANTITY_______________ U/M____________ LOT#________________________ PURITY(%)_________________________ ODOR (CIRCLE ONE) PASS FAIL IDENTITY (CIRCLE ONE) PASS FAIL
ANALYZER MAKE - SERVOMEX MODEL__________________ DATE______________ OPERATOR_______________ THIS TAG MUST BE REMOVED ONLY BY EMPLOYEE RESPONSIBLE FOR REFILLING.
-
INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64203-020 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 99 L in 100 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64203-020-01 40 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1993 2 NDC:64203-020-02 41 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1993 3 NDC:64203-020-03 46 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1993 4 NDC:64203-020-04 60 L in 1 DEWAR; Type 0: Not a Combination Product 01/01/1993 5 NDC:64203-020-05 683589 L in 1 TANK; Type 0: Not a Combination Product 01/01/1993 6 NDC:64203-020-06 1432282 L in 1 TANK; Type 0: Not a Combination Product 01/01/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 01/01/1993 Labeler - New Schryver LLC (808372536) Registrant - New Schryver LLC (808372536) Establishment Name Address ID/FEI Business Operations New Schryver LLC 058743753 manufacture(64203-020) Establishment Name Address ID/FEI Business Operations New Schryver LLC 025927706 manufacture(64203-020)