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NDC 69878-0001-00 OXYGEN 992 mL/L Details

OXYGEN 992 mL/L

OXYGEN is a RESPIRATORY (INHALATION) GAS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Gases Equipment Tools and Supplies Inc. The primary component is OXYGEN.

Product Information

NDC	69878-0001
Product ID	69878-001_ec6548f0-ddc0-52ee-e053-2995a90aa8af
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	OXYGEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	OXYGEN
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GAS
Route	RESPIRATORY (INHALATION)
Active Ingredient Strength	992
Active Ingredient Units	mL/L
Substance Name	OXYGEN
Labeler Name	Gases Equipment Tools and Supplies Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA205840
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69878-0001-00 (69878000100)

Pricing Information	N/A
NDC Package Code	69878-001-00
Billing NDC	69878000100
Package	7107 L in 1 CYLINDER (69878-001-00)
Marketing Start Date	2015-06-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a240fc7-1052-49fa-b048-a6581defbab9 Details

Package Label

INGREDIENTS AND APPEARANCE

OXYGEN

oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:69878-001(NDC:58420-001)
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	992 mL in 1 L

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69878-001-00	7107 L in 1 CYLINDER; Type 0: Not a Combination Product	06/02/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205840	06/02/2015

Labeler - Gases Equipment Tools and Supplies Inc (868658501)

Name	Address	ID/FEI	Business Operations
Establishment
Gases Equipment Tools and Supplies Inc		868658501	repack(69878-001)

Name	Address	ID/FEI	Business Operations
Establishment
AIRGAS USA, LLC		884607318	manufacture(69878-001)

Revised: 11/2022

Document Id: ec6548f0-ddc0-52ee-e053-2995a90aa8af

Set id: 4a240fc7-1052-49fa-b048-a6581defbab9

Version: 4

Effective Time: 20221101