dantrium

Generic: dantrolene sodium

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dantrium
Generic Name dantrolene sodium
Labeler par health usa, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

dantrolene sodium 20 mg/60mL

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 42023-123
Product ID 42023-123_7635e0c2-de42-44ca-9446-59bc0fc41b19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018264
Listing Expiration 2026-12-31
Marketing Start 2009-04-20

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 42023123
Hyphenated Format 42023-123

Supplemental Identifiers

RxCUI
856696 856698
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 dantrium (source: ndc)
Generic Name dantrolene sodium (source: ndc)
Application Number NDA018264 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/60mL
source: ndc
Packaging
  • 6 VIAL in 1 CARTON (42023-123-06) / 60 mL in 1 VIAL
source: ndc

Packages (1)

42023-123-06 6 VIAL in 1 CARTON (42023-123-06) / 60 mL in 1 VIAL

Ingredients (1)

dantrolene sodium (20 mg/60mL)

Linked Drug Pages (1)

Dantrium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "7635e0c2-de42-44ca-9446-59bc0fc41b19", "openfda": {"unii": ["287M0347EV"], "rxcui": ["856696", "856698"], "spl_set_id": ["4df35098-8702-46be-ac67-30cfdf1aa570"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL in 1 CARTON (42023-123-06)  / 60 mL in 1 VIAL", "package_ndc": "42023-123-06", "marketing_start_date": "20090420"}], "brand_name": "Dantrium", "product_id": "42023-123_7635e0c2-de42-44ca-9446-59bc0fc41b19", "dosage_form": "INJECTION", "pharm_class": ["Decreased Striated Muscle Contraction [PE]", "Decreased Striated Muscle Tone [PE]", "Skeletal Muscle Relaxant [EPC]"], "product_ndc": "42023-123", "generic_name": "dantrolene sodium", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dantrium", "active_ingredients": [{"name": "DANTROLENE SODIUM", "strength": "20 mg/60mL"}], "application_number": "NDA018264", "marketing_category": "NDA", "marketing_start_date": "20090420", "listing_expiration_date": "20261231"}