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United States · US · US:17270-5530_5bb16a0a-5502-4279-b7ed-e333a1edaaf1
Primatene Mist
In shortageOrange BookUNIISPLATC R03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerArmstrong Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1117270553001 INHALER in 1 CARTON (17270-5530-0) / 160 AEROSOL in 1 INHALER
Annotations
UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N205920
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Bitartrate, Lidocaine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "YKH834O4BH",
"rxcui": "3992",
"inchikey": "UCTWMZQNUQWSLP-VIFPVBQESA-N",
"display_name": "EPINEPHRINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"2170f081-c03f-47e8-bc63-4052c5e653fa": {
"match": "brand_token",
"title": "PRIMATENE (EPHEDRINE HYDROCHLORIDE) TABLET [FOUNDATION CONSUMER BRANDS]",
"spl_version": "2",
"published_date": "2024-11-11"
}
},
"productid": "17270-5530_5bb16a0a-5502-4279-b7ed-e333a1edaaf1",
"productndc": "17270-5530",
"dosage_form": "AEROSOL",
"orange_book": {
"appl_no": "205920",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.125MG/INH",
"product_no": "001",
"approval_date": "Nov 7, 2018"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "EPINEPHRINE",
"shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Primatene Mist",
"active_ingred_unit": "ug/1",
"application_number": "NDA205920",
"marketing_category": "NDA",
"nonproprietary_name": "Epinephrine Inhalation",
"start_marketing_date": "20181214",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code R03AA01.
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