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United States · US · US:0362-9048_85af79f0-c765-4758-8ae8-e68ebdb70dd8
Septocaine and Epinephrine
Orange BookUNIISPLATC N01BB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSeptodont Inc.
CountryUS (United States)
ATC codeN01BB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11036290480250 CARTRIDGE in 1 CARTON (0362-9048-02) / 1.7 mL in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
QS9014Q792
ARTICAINE HYDROCHLORIDE
RxCUI 2117
Orange Book
N020971
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QS9014Q792",
"rxcui": "2117",
"inchikey": "GDWDBGSWGNEMGJ-UHFFFAOYSA-N",
"display_name": "ARTICAINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBMUCOSAL",
"spl_meta": {
"0eba0bd2-ccb6-4f7e-8d0c-e4b4e6cdce03": {
"match": "brand_token",
"title": "SEPTOCAINE AND EPINEPHRINE (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [SEPTODONT INC.]",
"spl_version": "14",
"published_date": "2024-10-25"
}
},
"productid": "0362-9048_85af79f0-c765-4758-8ae8-e68ebdb70dd8",
"productndc": "0362-9048",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "020971",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 3, 2000"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)",
"product_no": "002",
"approval_date": "Mar 30, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE",
"proprietary_name": "Septocaine and Epinephrine",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "NDA020971",
"marketing_category": "NDA",
"nonproprietary_name": "Articaine Hydrochloride and Epinephrine Bitartrate",
"start_marketing_date": "20110112",
"active_numerator_strength": "40; .005"
}Related drugs
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