dantrolene

Generic: dantrolene

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dantrolene
Generic Name dantrolene
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dantrolene sodium 20 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9297
Product ID 0143-9297_769b1f03-2d55-42b7-b29d-60fb5275a67f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204762
Listing Expiration 2026-12-31
Marketing Start 2017-06-19

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 01439297
Hyphenated Format 0143-9297

Supplemental Identifiers

RxCUI
856696
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 dantrolene (source: ndc)
Generic Name dantrolene (source: ndc)
Application Number ANDA204762 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01)
source: ndc

Packages (1)

0143-9297-01 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01)

Ingredients (1)

dantrolene sodium (20 mg/1)

Linked Drug Pages (1)

Dantrolene ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "769b1f03-2d55-42b7-b29d-60fb5275a67f", "openfda": {"unii": ["287M0347EV"], "rxcui": ["856696"], "spl_set_id": ["ab0efc75-0598-4f4e-91ad-6195bb2661fe"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01)", "package_ndc": "0143-9297-01", "marketing_start_date": "20170619"}], "brand_name": "Dantrolene", "product_id": "0143-9297_769b1f03-2d55-42b7-b29d-60fb5275a67f", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Decreased Striated Muscle Contraction [PE]", "Decreased Striated Muscle Tone [PE]", "Skeletal Muscle Relaxant [EPC]"], "product_ndc": "0143-9297", "generic_name": "Dantrolene", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dantrolene", "active_ingredients": [{"name": "DANTROLENE SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA204762", "marketing_category": "ANDA", "marketing_start_date": "20170619", "listing_expiration_date": "20261231"}