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United States · US · US:0362-0557_2095bcd0-0dc6-4b6e-a86c-23140421e3d0
Marcaine
In shortageOrange 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
- ndc11036205570550 CARTRIDGE in 1 CARTON (0362-0557-05) / 1.8 mL in 1 CARTRIDGE
Annotations
UNII (FDA Substance ID)
AKA908P8J1
BUPIVACAINE HYDROCHLORIDE ANHYDROUS
RxCUI 1375412
Orange Book
A077250
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Bupivacaine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "AKA908P8J1",
"rxcui": "1375412",
"inchikey": "SIEYLFHKZGLBNX-UHFFFAOYSA-N",
"display_name": "BUPIVACAINE HYDROCHLORIDE ANHYDROUS",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBMUCOSAL",
"spl_meta": {
"67578b56-7540-487e-1fba-481255620e78": {
"match": "brand_token",
"title": "MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "38",
"published_date": "2026-06-01"
}
},
"productid": "0362-0557_2095bcd0-0dc6-4b6e-a86c-23140421e3d0",
"productndc": "0362-0557",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "077250",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "0.5%;0.0091MG/ML",
"product_no": "001",
"approval_date": "Sep 27, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE",
"shortage_reason": "Bupivacaine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Marcaine",
"active_ingred_unit": "mg/mL; mg/mL",
"application_number": "ANDA077250",
"marketing_category": "ANDA",
"nonproprietary_name": "bupivacaine hydrochloride and epinephrine bitartrate",
"start_marketing_date": "20180612",
"active_numerator_strength": "5; .005"
}Related drugs
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