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United States · US · US:60977-141_ce0e8c50-0a21-4dbe-bdc6-e64a26a120c7

Protopam Chloride

Orange BookUNIISPLATC V03AB04

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

Identification

ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeV03AB04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6097714101
    6 VIAL, SINGLE-DOSE in 1 PACKAGE (60977-141-01) / 20 mL in 1 VIAL, SINGLE-DOSE (60977-141-27)

Annotations

UNII (FDA Substance ID)
38X7XS076H
PRALIDOXIME CHLORIDE
RxCUI 55322
Orange Book
N014134
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "38X7XS076H",
    "rxcui": "55322",
    "inchikey": "HIGSLXSBYYMVKI-UHFFFAOYSA-N",
    "display_name": "PRALIDOXIME CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "2741d8fd-51c2-46be-880b-99f2b20a6137": {
      "match": "brand_token",
      "title": "PROTOPAM CHLORIDE (PRALIDOXIME CHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "15",
      "published_date": "2026-03-30"
    }
  },
  "productid": "60977-141_ce0e8c50-0a21-4dbe-bdc6-e64a26a120c7",
  "productndc": "60977-141",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "014134",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM/VIAL",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRALIDOXIME CHLORIDE",
  "proprietary_name": "Protopam Chloride",
  "active_ingred_unit": "g/20mL",
  "application_number": "NDA014134",
  "marketing_category": "NDA",
  "nonproprietary_name": "pralidoxime chloride",
  "start_marketing_date": "19650310",
  "active_numerator_strength": "1"
}

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