United States· US:0362-0557_2095bcd0-0dc6-4b6e-a86c-23140421e3d0
Marcaine
A medicinal product containing bupivacaine hydrochloride anhydrous; epinephrine bitartrate, registered in United States by Septodont, Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE
- Manufacturer
- Septodont, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc11036205570550 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE
- ndc110362-0557-05
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Bupivacaine hydrochloride anhydrous; epinephrine bitartrate in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomBupivacaine 25mg/10ml (0.25%) / Adrenaline (base) 50micrograms/10ml (1 in 200,000) solution for injection ampoulesAdvanz Pharma
- CanadaBUPIVACAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTIONNOVOCOL PHARMACEUTICAL OF CANADA INC
- FinlandApiyaqMacure Pharma ApS
- IrelandMarcain 0.25% w/v with Adrenaline (Epinephrine, 5 micrograms per ml) (1:200,000) Solution for InjectionAspen Pharma Trading Limited
- SwedenApiyaq 2,5 mg/ml + 5 mikrogram/ml Injektionsvätska, lösningMACURE PHARMA ApS
- SwitzerlandCarbostesin-Adrenalin 2,5 mg/ml, Injektions-/InfusionslösungAspen Pharma Schweiz GmbH
- GermanyBupivacain Mit Epinephrin JenapharmMibe Gmbh Arzneimittel
- PolandMarcaine - Adrenaline 0,5%Aspen Pharma Trading Ltd.
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Denmark · Apiyaq
- Spain · Bupivacaína + Epinefrina Physan, Inibsacain
- Finland · Apiyaq
- Italy · Bupicain Con Adrenalina
- Norway · Apiyaq
- Sweden · Apiyaq
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/fc7fb5ed-1249-42d9-b6a8-61c2112ea829 GET /v1/drugs/fc7fb5ed-1249-42d9-b6a8-61c2112ea829?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "SUBMUCOSAL",
"source": "ndc",
"strength": "5; .005",
"substance": "BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE",
"productndc": "0362-0557",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL; mg/mL",
"application_number": "ANDA077250",
"marketing_category": "ANDA"
}See everything about bupivacaine hydrochloride anhydrous; epinephrine bitartrate.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.