ryanodex dantrolene sodium

Generic: dantrolene sodium

Labeler: eagle pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ryanodex dantrolene sodium
Generic Name dantrolene sodium
Labeler eagle pharmaceuticals, inc.
Dosage Form INJECTION, SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

dantrolene sodium 250 mg/5mL

Manufacturer
Eagle Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 42367-540
Product ID 42367-540_2489f99a-e34f-4773-be47-35ebb68cabfb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205579
Listing Expiration 2026-12-31
Marketing Start 2014-07-23

Pharmacologic Class

Classes
decreased striated muscle contraction [pe] decreased striated muscle tone [pe] skeletal muscle relaxant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42367540
Hyphenated Format 42367-540

Supplemental Identifiers

RxCUI
1544753 1544758
UPC
0342367540325
UNII
287M0347EV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ryanodex dantrolene sodium (source: ndc)
Generic Name dantrolene sodium (source: ndc)
Application Number NDA205579 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (42367-540-32) / 20 mL in 1 VIAL
source: ndc

Packages (1)

42367-540-32 1 VIAL in 1 CARTON (42367-540-32) / 20 mL in 1 VIAL

Ingredients (1)

dantrolene sodium (250 mg/5mL)

Linked Drug Pages (1)

RYANODEX dantrolene sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2489f99a-e34f-4773-be47-35ebb68cabfb", "openfda": {"upc": ["0342367540325"], "unii": ["287M0347EV"], "rxcui": ["1544753", "1544758"], "spl_set_id": ["8f7b3ac0-604d-4c78-b545-5e0f8ea3d698"], "manufacturer_name": ["Eagle Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (42367-540-32)  / 20 mL in 1 VIAL", "package_ndc": "42367-540-32", "marketing_start_date": "20140723"}], "brand_name": "RYANODEX dantrolene sodium", "product_id": "42367-540_2489f99a-e34f-4773-be47-35ebb68cabfb", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Decreased Striated Muscle Contraction [PE]", "Decreased Striated Muscle Tone [PE]", "Skeletal Muscle Relaxant [EPC]"], "product_ndc": "42367-540", "generic_name": "dantrolene sodium", "labeler_name": "Eagle Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RYANODEX", "brand_name_suffix": "dantrolene sodium", "active_ingredients": [{"name": "DANTROLENE SODIUM", "strength": "250 mg/5mL"}], "application_number": "NDA205579", "marketing_category": "NDA", "marketing_start_date": "20140723", "listing_expiration_date": "20261231"}