Dantrolene Sodium

Orange BookUNIISPLATC M03CA01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeM03CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7216220461
100 CAPSULE in 1 BOTTLE (72162-2046-1)

Annotations

UNII (FDA Substance ID)

287M0347EV

DANTROLENE SODIUM

RxCUI 3106

Orange Book

A076686

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": "72162-2046_fc116143-e804-4fa3-abbd-13a5690e957c",
  "productndc": "72162-2046",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076686",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Oct 24, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Oct 24, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Oct 24, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DANTROLENE SODIUM",
  "proprietary_name": "Dantrolene Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076686",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dantrolene sodium",
  "start_marketing_date": "20051026",
  "active_numerator_strength": "50"
}

Related drugs

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