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United States · US · US:63323-180_621c0b5c-be50-4bb5-9475-6acba6114cbe

Pyridoxine Hydrochloride

Orange BookUNIISPLATC A11HA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeA11HA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332318001
    25 VIAL in 1 TRAY (63323-180-01) / 1 mL in 1 VIAL (63323-180-00)

Annotations

UNII (FDA Substance ID)
68Y4CF58BV
PYRIDOXINE HYDROCHLORIDE
RxCUI 203164
Orange Book
A080618
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "68Y4CF58BV",
    "rxcui": "203164",
    "inchikey": "ZUFQODAHGAHPFQ-UHFFFAOYSA-N",
    "display_name": "PYRIDOXINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "a56d11c0-b033-4201-85ff-fc710506481a": {
      "match": "brand_token",
      "title": "PYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "5",
      "published_date": "2024-10-21"
    }
  },
  "productid": "63323-180_621c0b5c-be50-4bb5-9475-6acba6114cbe",
  "productndc": "63323-180",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "080618",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PYRIDOXINE HYDROCHLORIDE",
  "proprietary_name": "Pyridoxine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA080618",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PYRIDOXINE HYDROCHLORIDE",
  "start_marketing_date": "19720814",
  "active_numerator_strength": "100"
}

Related drugs

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