dantrolene sodium

Generic: dantrolene sodium

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dantrolene sodium
Generic Name dantrolene sodium
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dantrolene sodium 25 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-217
Product ID 50268-217_32f9f951-bf56-47f2-e063-6394a90a9c6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076856
Listing Expiration 2026-12-31
Marketing Start 2021-03-09

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 50268217
Hyphenated Format 50268-217

Supplemental Identifiers

RxCUI
856656
UNII
287M0347EV

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 sodium (source: ndc)
Generic Name dantrolene sodium (source: ndc)
Application Number ANDA076856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-217-15) / 1 CAPSULE in 1 BLISTER PACK (50268-217-11)
source: ndc

Packages (1)

50268-217-15 50 BLISTER PACK in 1 BOX (50268-217-15) / 1 CAPSULE in 1 BLISTER PACK (50268-217-11)

Ingredients (1)

dantrolene sodium (25 mg/1)

Linked Drug Pages (1)

Dantrolene Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32f9f951-bf56-47f2-e063-6394a90a9c6d", "openfda": {"unii": ["287M0347EV"], "rxcui": ["856656"], "spl_set_id": ["bd1ef298-2219-2a01-e053-2995a90abb08"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-217-15)  / 1 CAPSULE in 1 BLISTER PACK (50268-217-11)", "package_ndc": "50268-217-15", "marketing_start_date": "20210309"}], "brand_name": "Dantrolene Sodium", "product_id": "50268-217_32f9f951-bf56-47f2-e063-6394a90a9c6d", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Striated Muscle Contraction [PE]", "Decreased Striated Muscle Tone [PE]", "Skeletal Muscle Relaxant [EPC]"], "product_ndc": "50268-217", "generic_name": "Dantrolene Sodium", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dantrolene Sodium", "active_ingredients": [{"name": "DANTROLENE SODIUM", "strength": "25 mg/1"}], "application_number": "ANDA076856", "marketing_category": "ANDA", "marketing_start_date": "20210309", "listing_expiration_date": "20261231"}