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United States · US · US:51662-1410_0ffba8c5-bf5d-a665-e063-6294a90a64f6

PYRIDOXINE HCI

Orange BookUNIISPLATC A11HA02

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeA11HA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166214101
    1 mL in 1 VIAL (51662-1410-1)
  • ndc11
    5166214103
    25 POUCH in 1 CASE (51662-1410-3) / 1 VIAL in 1 POUCH (51662-1410-2) / 1 mL in 1 VIAL

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": "51662-1410_0ffba8c5-bf5d-a665-e063-6294a90a64f6",
  "productndc": "51662-1410",
  "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 HCI",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA080618",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PYRIDOXINE HCI",
  "start_marketing_date": "20191008",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code A11HA02.

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