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FDA Approval

Ammonia Inhalants

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 14, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ammonia(0.045 g in 0.3 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ammonia Inhalants

Product Details

NDC Product Code
50090-0342
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
October 12, 2020
AmmoniaActive
Code: 5138Q19F1XClass: ACTIBQuantity: 0.045 g in 0.3 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8Class: IACT
NUTMEG OILInactive
Code: Z1CLM48948Class: IACT
LEMON OILInactive
Code: I9GRO824LLClass: IACT
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