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United States · US · US:70069-753_2b24af95-6f20-4945-bf8c-742f1d6f2721
Bupivacaine hydrochloride
In shortageOrange BookUNIISPLATC N01BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSomerset Therapeutics, LLC
CountryUS (United States)
ATC codeN01BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1170069753011 VIAL in 1 CARTON (70069-753-01) / 50 mL in 1 VIAL
- ndc11700697531010 VIAL in 1 CARTON (70069-753-10) / 50 mL in 1 VIAL
- ndc11700697532525 VIAL in 1 CARTON (70069-753-25) / 50 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDE
RxCUI 267396
Orange Book
A217792
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Bupivacaine Hydrochloride, Epinephrine Bitartrate 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": "INFILTRATION; PERINEURAL",
"spl_meta": {
"8f8f4ece-de78-4c13-8d9f-c3bb7053019d": {
"match": "brand_token",
"title": "BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]",
"spl_version": "17",
"published_date": "2026-04-30"
}
},
"productid": "70069-753_2b24af95-6f20-4945-bf8c-742f1d6f2721",
"productndc": "70069-753",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "217792",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.25%",
"product_no": "001",
"approval_date": "Nov 20, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.5%",
"product_no": "002",
"approval_date": "Nov 20, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUPIVACAINE HYDROCHLORIDE",
"shortage_reason": "Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection",
"shortage_status": "current",
"proprietary_name": "Bupivacaine hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA217792",
"marketing_category": "ANDA",
"nonproprietary_name": "Bupivacaine hydrochloride",
"start_marketing_date": "20231127",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code N01BB01.
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