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United States · US · US:24201-010_092d00fe-9f8a-47ea-b9bc-07ef41d2b418

Pentobarbital Sodium

Orange BookUNIISPLATC N05CA01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN05CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2420101020
    1 VIAL in 1 CARTON (24201-010-20) / 20 mL in 1 VIAL
  • ndc11
    2420101050
    1 VIAL in 1 CARTON (24201-010-50) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
NJJ0475N0S
PENTOBARBITAL SODIUM
RxCUI 203085
Orange Book
A203619
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NJJ0475N0S",
    "rxcui": "203085",
    "inchikey": "QGMRQYFBGABWDR-UHFFFAOYSA-M",
    "display_name": "PENTOBARBITAL SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "d375b92a-baa1-4d63-9ad1-1467dcfde7d5": {
      "match": "brand_token",
      "title": "PENTOBARBITAL SODIUM INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "5",
      "published_date": "2026-03-06"
    }
  },
  "productid": "24201-010_092d00fe-9f8a-47ea-b9bc-07ef41d2b418",
  "productndc": "24201-010",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203619",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Nov 13, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENTOBARBITAL SODIUM",
  "proprietary_name": "Pentobarbital Sodium",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203619",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pentobarbital Sodium",
  "start_marketing_date": "20251001",
  "active_numerator_strength": "50"
}

Related drugs

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