dantrolene sodium

Orange BookUNIISPLATC M03CA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeM03CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051846680
50 POUCH in 1 BOX (70518-4668-0) / 1 CAPSULE in 1 POUCH (70518-4668-1)

Annotations

UNII (FDA Substance ID)

287M0347EV

DANTROLENE SODIUM

RxCUI 3106

Orange Book

N017443

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "287M0347EV",
    "rxcui": "3106",
    "inchikey": "LTWQNYPDAUSXBC-CDJGKPBYSA-L",
    "display_name": "DANTROLENE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c3c45b27-f786-456e-95d6-2e38ef36190a": {
      "match": "brand_token",
      "title": "DANTROLENE SODIUM CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "15",
      "published_date": "2026-04-30"
    }
  },
  "productid": "70518-4668_53448097-5763-e754-e063-6394a90a1b25",
  "productndc": "70518-4668",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "017443",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DANTROLENE SODIUM",
  "proprietary_name": "dantrolene sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017443",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "dantrolene sodium",
  "start_marketing_date": "20260527",
  "active_numerator_strength": "50"
}

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