revonto

Generic: dantrolene sodium

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name revonto
Generic Name dantrolene sodium
Labeler propharma distribution
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dantrolene sodium 20 mg/60mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-003
Product ID 84549-003_463e554f-a0fa-ab45-e063-6294a90abcf6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078378
Listing Expiration 2026-12-31
Marketing Start 2021-04-09

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 84549003
Hyphenated Format 84549-003

Supplemental Identifiers

RxCUI
856696 1012465
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 revonto (source: ndc)
Generic Name dantrolene sodium (source: ndc)
Application Number ANDA078378 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/60mL
source: ndc
Packaging
  • 60 mL in 1 VIAL, GLASS (84549-003-67)
source: ndc

Packages (1)

84549-003-67 60 mL in 1 VIAL, GLASS (84549-003-67)

Ingredients (1)

dantrolene sodium (20 mg/60mL)

Linked Drug Pages (1)

Revonto ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "463e554f-a0fa-ab45-e063-6294a90abcf6", "openfda": {"unii": ["287M0347EV"], "rxcui": ["856696", "1012465"], "spl_set_id": ["3edcfad5-00ad-7587-e063-6394a90addf3"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 VIAL, GLASS (84549-003-67)", "package_ndc": "84549-003-67", "marketing_start_date": "20250915"}], "brand_name": "Revonto", "product_id": "84549-003_463e554f-a0fa-ab45-e063-6294a90abcf6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Decreased Striated Muscle Contraction [PE]", "Decreased Striated Muscle Tone [PE]", "Skeletal Muscle Relaxant [EPC]"], "product_ndc": "84549-003", "generic_name": "dantrolene sodium", "labeler_name": "ProPharma Distribution", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Revonto", "active_ingredients": [{"name": "DANTROLENE SODIUM", "strength": "20 mg/60mL"}], "application_number": "ANDA078378", "marketing_category": "ANDA", "marketing_start_date": "20210409", "listing_expiration_date": "20261231"}