Label: OXYGEN liquid
OXYGEN gas
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NDC Code(s):
59400-001-01,
59400-001-02,
59400-001-03,
59400-001-04, view more59400-001-05, 59400-001-06, 59400-001-07, 59400-001-08, 59400-005-01, 59400-005-02, 59400-005-03, 59400-005-04, 59400-005-05, 59400-005-06, 59400-005-07, 59400-005-08
- Packager: BayCare Home Care, Inc.
- 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 February 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Liquid Oxygen; Product NDC: 59400-005
- Compressed Oxygen; Product NDC: 59400-001
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59400-005 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 210 mg in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59400-005-01 34168 kg in 1 DEWAR; Type 0: Not a Combination Product 09/23/2022 02/15/2023 2 NDC:59400-005-04 17084 kg in 1 DEWAR; Type 0: Not a Combination Product 09/23/2022 02/15/2023 3 NDC:59400-005-02 37585 kg in 1 DEWAR; Type 0: Not a Combination Product 09/23/2022 02/15/2023 4 NDC:59400-005-03 25626 kg in 1 DEWAR; Type 0: Not a Combination Product 09/23/2022 02/15/2023 5 NDC:59400-005-05 22.68 kg in 1 DEWAR; Type 0: Not a Combination Product 02/15/2023 6 NDC:59400-005-06 34.02 kg in 1 DEWAR; Type 0: Not a Combination Product 02/15/2023 7 NDC:59400-005-07 45.36 kg in 1 DEWAR; Type 0: Not a Combination Product 02/15/2023 8 NDC:59400-005-08 49.9 kg in 1 DEWAR; Type 0: Not a Combination Product 02/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 09/23/2022 OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59400-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 210 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59400-001-01 670 L in 1 CYLINDER; Type 0: Not a Combination Product 09/23/2022 02/15/2023 2 NDC:59400-001-02 425 L in 1 CYLINDER; Type 0: Not a Combination Product 09/23/2022 3 NDC:59400-001-03 140 L in 1 CYLINDER; Type 0: Not a Combination Product 09/23/2022 02/15/2023 4 NDC:59400-001-04 7760 L in 1 CYLINDER; Type 0: Not a Combination Product 09/23/2022 02/15/2023 5 NDC:59400-001-05 7075 L in 1 CYLINDER; Type 0: Not a Combination Product 02/15/2023 6 NDC:59400-001-06 680 L in 1 CYLINDER; Type 0: Not a Combination Product 02/15/2023 7 NDC:59400-001-07 170 L in 1 CYLINDER; Type 0: Not a Combination Product 02/15/2023 8 NDC:59400-001-08 255 L in 1 CYLINDER; Type 0: Not a Combination Product 02/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved medical gas 09/23/2022 Labeler - BayCare Home Care, Inc. (794046607) Establishment Name Address ID/FEI Business Operations BayCare Home Care, Inc 794046607 manufacture(59400-001, 59400-005) Establishment Name Address ID/FEI Business Operations BayCare Home Care, Inc 832097641 manufacture(59400-001, 59400-005)