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United States · US · US:49502-500_81569d26-e9b3-4c1d-ac34-8a4cf5b4a98b
EPIPEN
In shortageOrange BookUNIISPLATC R03AA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeR03AA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1149502500022 CONTAINER in 1 CARTON (49502-500-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-500-01) / .3 mL in 1 SYRINGE, GLASS
- ndc1149502500922 CONTAINER in 1 CARTON (49502-500-92) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
YKH834O4BH
EPINEPHRINE
RxCUI 3992
Orange Book
N019430
ABAB
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": "INTRAMUSCULAR",
"spl_meta": {
"7560c201-9246-487c-a13b-6295db04274a": {
"match": "brand_token",
"title": "EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [VIATRIS SPECIALTY LLC]",
"spl_version": "37",
"published_date": "2025-02-12"
}
},
"productid": "49502-500_81569d26-e9b3-4c1d-ac34-8a4cf5b4a98b",
"productndc": "49502-500",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "019430",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.3MG/DELIVERY",
"product_no": "001",
"approval_date": "Dec 22, 1987"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.15MG/DELIVERY",
"product_no": "002",
"approval_date": "Dec 22, 1987"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.3MG/DELIVERY",
"product_no": "003",
"approval_date": "Aug 3, 1995"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.15MG/DELIVERY",
"product_no": "004",
"approval_date": "Aug 3, 1995"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPINEPHRINE",
"shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "EPIPEN",
"active_ingred_unit": "mg/.3mL",
"application_number": "NDA019430",
"marketing_category": "NDA",
"nonproprietary_name": "epinephrine",
"start_marketing_date": "19871222",
"active_numerator_strength": ".3"
}Related drugs
Other records sharing ATC code R03AA01.
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