NDC 17270-553

Primatene Mist

Epinephrine Inhalation

Primatene Mist is a Respiratory (inhalation) Aerosol in the Human Otc Drug category. It is labeled and distributed by Armstrong Pharmaceuticals, Inc.. The primary component is Epinephrine.

• Product ID: 17270-553_56db4b73-c9ce-413c-8c60-588873a66df8
• NDC: 17270-553
• Product Type: Human Otc Drug
• Proprietary Name: Primatene Mist
• Generic Name: Epinephrine Inhalation
• Dosage Form: Aerosol
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2018-12-14
• Marketing Category: NDA / NDA
• Application Number: NDA205920
• Labeler Name: Armstrong Pharmaceuticals, Inc.
• Substance Name: EPINEPHRINE
• Active Ingredient Strength: 125 ug/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 17270-553-00

1 INHALER in 1 CARTON (17270-553-00) > 160 AEROSOL in 1 INHALER

• Marketing Start Date: 2018-12-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17270-553-00 [17270055300]

Primatene Mist AEROSOL

• Marketing Category: NDA
• Application Number: NDA205920
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2018-12-14

Drug Details

Active Ingredients

Ingredient	Strength
EPINEPHRINE	125 ug/1

OpenFDA Data

• SPL SET ID: 95011f7e-51be-4851-80a6-a7e9c6cad82a
• Manufacturer:
  • Armstrong Pharmaceuticals, Inc.
• UNII:
  • YKH834O4BH
• RxNorm Concept Unique ID - RxCUI:
  • 2109088
  • 2109083