dantrium

Generic: dantrolene sodium

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dantrium
Generic Name dantrolene sodium
Labeler endo usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dantrolene sodium 25 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 42023-124
Product ID 42023-124_edb780bb-3d09-4f16-9a76-c263f6de8713
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017443
Listing Expiration 2026-12-31
Marketing Start 2008-08-01

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 42023124
Hyphenated Format 42023-124

Supplemental Identifiers

RxCUI
856652 856654 856656 856658 856660 856662
UPC
0342023126016 0342023124012 0342023125019
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 NDA017443 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (42023-124-01)
source: ndc

Packages (1)

42023-124-01 100 CAPSULE in 1 BOTTLE (42023-124-01)

Ingredients (1)

dantrolene sodium (25 mg/1)

Linked Drug Pages (1)

Dantrium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "edb780bb-3d09-4f16-9a76-c263f6de8713", "openfda": {"upc": ["0342023126016", "0342023124012", "0342023125019"], "unii": ["287M0347EV"], "rxcui": ["856652", "856654", "856656", "856658", "856660", "856662"], "spl_set_id": ["57b4eec1-49e1-432c-95ae-0fe36e32d64b"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (42023-124-01)", "package_ndc": "42023-124-01", "marketing_start_date": "20080801"}], "brand_name": "Dantrium", "product_id": "42023-124_edb780bb-3d09-4f16-9a76-c263f6de8713", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Striated Muscle Contraction [PE]", "Decreased Striated Muscle Tone [PE]", "Skeletal Muscle Relaxant [EPC]"], "product_ndc": "42023-124", "generic_name": "dantrolene sodium", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dantrium", "active_ingredients": [{"name": "DANTROLENE SODIUM", "strength": "25 mg/1"}], "application_number": "NDA017443", "marketing_category": "NDA", "marketing_start_date": "20080801", "listing_expiration_date": "20261231"}