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United States · US · US:63323-293_b3d50315-0f09-4294-a788-990036dfc45c

Polocaine-MPF

Orange BookUNIIATC 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

  • ndc11
    6332329337
    25 VIAL, SINGLE-DOSE in 1 TRAY (63323-293-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-293-01)

Annotations

UNII (FDA Substance ID)
4VFX2L7EM5
MEPIVACAINE HYDROCHLORIDE
RxCUI 203185
Orange Book
A089408
Raw payload (JSON)
{
  "unii": {
    "unii": "4VFX2L7EM5",
    "rxcui": "203185",
    "inchikey": "RETIMRUQNCDCQB-UHFFFAOYSA-N",
    "display_name": "MEPIVACAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "EPIDURAL; INFILTRATION",
  "productid": "63323-293_b3d50315-0f09-4294-a788-990036dfc45c",
  "productndc": "63323-293",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "089408",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "1.5%",
        "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-MPF",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA089408",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MEPIVACAINE HYDROCHLORIDE",
  "start_marketing_date": "20090721",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code N01BB03.

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