Heliox

Product NDC
54776-006
Requested package NDC
54776-006-01
11-digit product format
547760006
Labeler code
54776
Product ID
54776-006_eb40a93c-f782-317c-e053-2995a90ae19e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Heliox
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Spec Connection International Inc
Application
NDA205889
Marketing category
NDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
OXYGEN
Active strength
300 mL/L
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54776-00654776-006-01DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENWELDERS SUPPLY COMPANY OF LOUISVILLE, INC.1017fba9-0472-88cf-e063-6294a90afe1c2026-04-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMITCHELL WELDING SUPPLY DBA Meritus Texas704755e8-239d-18d6-e053-2991aa0ab7d22026-03-24Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMatheson Tri-Gas, Inc.d7c5336e-3afe-2763-e053-2a95a90ae78f2026-03-13Exact identifier
application applno (NDA): 205889
application number: NDA205889
RECONSTITUTED AIRRECONSTITUTED AIRWELDERS SUPPLY COMPANY OF LOUISVILLE, INC.497829cf-edd9-eb06-e063-6394a90a80e42026-01-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENCorrigan Propane LLC dba Blue Water Industrial Productseed9ed38-3eba-4aac-b2e8-fbfaa4549dba2026-01-25Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENPlains Welding Supply, Inc.0bfa29ff-cac6-40b5-880d-6cbf13a50c512025-12-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENHelget Gas Productsf791c94b-7fba-3857-e053-6294a90ac6be2025-12-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
AirAIRSYOXSA, Inc.0087ce2c-2c34-4a37-83e1-e0cabb87fc7c2025-12-12Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENT J Nowak Supply Co Inc94540cd6-3795-ac60-e053-2995a90afcbd2025-12-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENTIMS SOUTH TEXAS LLCbd23d80b-7ca3-4cf6-bd90-6b6ec7a1bbf92025-12-09Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENHELGET, INC.fc4d37c6-d6a1-24ef-e053-6394a90a8b0f2025-12-09Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENRotech Healthcare Inc28a03918-92a5-1bd0-e063-6394a90ab6722025-12-08Exact identifier
application applno (NDA): 205889
application number: NDA205889
Reconstituted AirRECONSTITUTED AIRHelget Gas Products436c1132-5ac9-b396-e063-6394a90adec42025-12-05Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 38/62OXYGEN/NITROGEN 38/62MATHESON TRI-GAS, INC.f5260a57-c389-3e7a-e053-2995a90a30f72025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 25/75OXYGEN/NITROGEN 25/75MATHESON TRI-GAS, INC.f5260aa2-6da8-25c6-e053-2995a90aca972025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 9.7/90.3OXYGEN/NITROGEN 9.7/90.3MATHESON TRI-GAS, INC.f52684b1-76fb-2184-e053-2a95a90adca42025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 10/90OXYGEN/NITROGEN 10/90MATHESON TRI-GAS, INC.f5254763-fef1-1b64-e053-2a95a90aa47e2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 25/75OXYGEN/HELIUM 25/75MATHESON TRI-GAS, INC.10bcb7de-ec3a-ee58-e063-6294a90a4a152025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 15/85OXYGEN/NITROGEN 15/85MATHESON TRI-GAS, INC.f525e843-6efa-25c4-e053-2995a90a9cdd2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 26/74OXYGEN/NITROGEN 26/74MATHESON TRI-GAS, INC.f5261ce4-6850-6212-e053-2995a90a42762025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54776-006HELIOX GAS [SPEC CONNECTION INTERNATIONAL INC]8Legacy NDC20241121_614182b5-5aa5-9efd-e053-2991aa0a7578.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54776-006-0154776000601707 L in 1 CYLINDER (54776-006-01) 707 l2013-01-010000-00-00NoNoCurrent