dantrolene sodium

Orange BookUNIISPLATC M03CA01

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

Identification

ManufacturerEndo USA, Inc.

CountryUS (United States)

ATC codeM03CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4988436301
100 CAPSULE in 1 BOTTLE (49884-363-01)

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": "49884-363_eaaa53d2-744b-4529-ad62-84ab6b4fdd51",
  "productndc": "49884-363",
  "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": "20160328",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code M03CA01.

Access this data programmatically

Query dantrolene sodium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs