🇺🇸
United States · US · US:0362-1200_6ec4f11a-4a43-4a5b-8072-eefcc695b4be
Flavalta
In shortageOrange BookUNIISPLATC A01AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSeptodont, Inc.
CountryUS (United States)
ATC codeA01AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11036212005050 CARTRIDGE in 1 CARTON (0362-1200-50) / 1.7 mL in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
30Q7KI53AK
EPINEPHRINE BITARTRATE
RxCUI 203180
Orange Book
N216564
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Epinephrine Bitartrate, Lidocaine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "30Q7KI53AK",
"rxcui": "203180",
"inchikey": "YLXIPWWIOISBDD-NDAAPVSOSA-N",
"display_name": "EPINEPHRINE BITARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBMUCOSAL",
"spl_meta": {
"3f9f9b4f-bf6c-4b57-ac1a-98fd1a9a369d": {
"match": "brand_token",
"title": "FLAVALTA (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE) INJECTION, SOLUTION [SEPTODONT, INC.]",
"spl_version": "2",
"published_date": "2026-04-02"
}
},
"productid": "0362-1200_6ec4f11a-4a43-4a5b-8072-eefcc695b4be",
"productndc": "0362-1200",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "216564",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.017MG BASE/1.7ML (EQ 0.01MG BASE/ML);34MG/1.7ML (20MG/ML)",
"product_no": "001",
"approval_date": "Mar 19, 2026"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE",
"shortage_reason": "Epinephrine Bitartrate, Lidocaine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Flavalta",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA216564",
"marketing_category": "NDA",
"nonproprietary_name": "Lidocaine Hydrochloride and Epinephrine",
"start_marketing_date": "20260319",
"active_numerator_strength": ".01; 20"
}Related drugs
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