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United States · US · US:63323-283_b3d50315-0f09-4294-a788-990036dfc45c
Polocaine
Orange BookUNIISPLATC N01BB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN01BB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11633232835725 VIAL, MULTI-DOSE in 1 TRAY (63323-283-57) / 50 mL in 1 VIAL, MULTI-DOSE (63323-283-01)
Annotations
UNII (FDA Substance ID)
4VFX2L7EM5
MEPIVACAINE HYDROCHLORIDE
RxCUI 203185
Orange Book
A089407
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4VFX2L7EM5",
"rxcui": "203185",
"inchikey": "RETIMRUQNCDCQB-UHFFFAOYSA-N",
"display_name": "MEPIVACAINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INFILTRATION",
"spl_meta": {
"eb7e2284-fe8d-46ad-b1d3-92ee2c6222bf": {
"match": "brand_token",
"title": "POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NOVOCOL PHARMACEUTICAL OF CANADA INC.]",
"spl_version": "1",
"published_date": "2026-03-30"
}
},
"productid": "63323-283_b3d50315-0f09-4294-a788-990036dfc45c",
"productndc": "63323-283",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "089407",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Dec 1, 1986"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MEPIVACAINE HYDROCHLORIDE",
"proprietary_name": "Polocaine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA089407",
"marketing_category": "ANDA",
"nonproprietary_name": "MEPIVACAINE HYDROCHLORIDE",
"start_marketing_date": "20090720",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N01BB03.
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