FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Primatene Mist
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE125 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui2109083, 2109088

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17270-5530-0Primatene Mist1 in 1 CARTONAEROSOL15
17270-5530-0Primatene Mist160 in 1 INHALERAEROSOL1605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17270-5530PRIMATENE MIST (EPINEPHRINE INHALATION) AEROSOL [ARMSTRONG PHARMACEUTICALS, INC.]5Current NDC, 2 package rows20240820_95011f7e-51be-4851-80a6-a7e9c6cad82a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2109083EPINEPHrine 0.125 MG/ACTUAT in 160 ACTUAT Metered Dose InhalerPSN95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109088Primatene MIST 0.125 MG/ACTUAT in 160 ACTUAT Metered Dose InhalerPSN95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109088160 ACTUAT epinephrine 0.125 MG/ACTUAT Metered Dose Inhaler [Primatene Mist Inhaler]SBD95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109083160 ACTUAT epinephrine 0.125 MG/ACTUAT Metered Dose InhalerSCD95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109088160 ACTUAT Primatene Mist Inhaler 0.125 MG/ACTUAT Metered Dose InhalerSY95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109083epinephrine 0.125 MG/ACTUAT per 160 ACTUAT Metered Dose InhalerSY95011f7e-51be-4851-80a6-a7e9c6cad82a5
2109088Primatene Mist 0.125 MG/ACTUAT per 160 ACTUAT Metered Dose InhalerSY95011f7e-51be-4851-80a6-a7e9c6cad82a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17270-5530-0172705530001 INHALER in 1 CARTON (17270-5530-0) / 160 AEROSOL in 1 INHALER1 inhaler2018-12-14NoNoCurrent