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United States · US · US:70594-121_afc179ac-71b9-4021-8b71-3372bf590e4a
Bupivacine HCl
In shortageOrange BookUNIIATC N01BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXellia Pharmaceuticals USA LLC
CountryUS (United States)
ATC codeN01BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705941210130 mL in 1 VIAL, SINGLE-DOSE (70594-121-01)
Annotations
UNII (FDA Substance ID)
7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDE
RxCUI 267396
Orange Book
A091487
APAPAP
FDA shortage
Currently in shortage
Bupivacaine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "7TQO7W3VT8",
"rxcui": "267396",
"inchikey": "HUCIWBPMHXGLFM-UHFFFAOYSA-N",
"display_name": "BUPIVACAINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "EPIDURAL; INTRACAUDAL; PERINEURAL",
"productid": "70594-121_afc179ac-71b9-4021-8b71-3372bf590e4a",
"productndc": "70594-121",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "091487",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5%",
"product_no": "001",
"approval_date": "Oct 18, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.25%",
"product_no": "002",
"approval_date": "Oct 18, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.75%",
"product_no": "003",
"approval_date": "Oct 18, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPIVACAINE HYDROCHLORIDE",
"shortage_reason": "Bupivacaine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Bupivacine HCl",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA091487",
"marketing_category": "ANDA",
"nonproprietary_name": "Bupivacaine hydrochloride",
"start_marketing_date": "20230601",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code N01BB01.
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