Primatene Mist

Product NDC
17270-5530
11-digit product format
172705530
Labeler code
17270
Product ID
17270-5530_5bb16a0a-5502-4279-b7ed-e333a1edaaf1
Type
HUMAN OTC DRUG
Nonproprietary name
Epinephrine Inhalation
Dosage form
AEROSOL
Route
RESPIRATORY (INHALATION)
Labeler
Armstrong Pharmaceuticals, Inc.
Application
NDA205920
Marketing category
NDA
Marketing start
2018-12-14
Substance
EPINEPHRINE
Active strength
125 ug/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
YKH834O4BHEPINEPHRINE51-43-4EPINEPHRINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17270-5530-0172705530001 INHALER in 1 CARTON (17270-5530-0) / 160 AEROSOL in 1 INHALER1 inhaler2018-12-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Primatene Mist - Armstrong Pharmaceuticals, Inc.Armstrong Pharmaceuticals, Inc.2020-07-01HUMAN OTC DRUG LABEL5