revonto

Generic: dantrolene sodium

Labeler: uswm, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dantrolene sodium 20 mg/60mL

Manufacturer
USWM, LLC

Identifiers & Regulatory

Product NDC 78670-003
Product ID 78670-003_e2a8cdae-f253-4b7a-b9ab-c66506106aef
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 78670003
Hyphenated Format 78670-003

Supplemental Identifiers

RxCUI
856696 1012465
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 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
  • 6 VIAL, GLASS in 1 CARTON (78670-003-67) / 60 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

78670-003-67 6 VIAL, GLASS in 1 CARTON (78670-003-67) / 60 mL in 1 VIAL, GLASS

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": "e2a8cdae-f253-4b7a-b9ab-c66506106aef", "openfda": {"unii": ["287M0347EV"], "rxcui": ["856696", "1012465"], "spl_set_id": ["f1650487-32bd-4017-b9c2-b38829a531af"], "manufacturer_name": ["USWM, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL, GLASS in 1 CARTON (78670-003-67)  / 60 mL in 1 VIAL, GLASS", "package_ndc": "78670-003-67", "marketing_start_date": "20210409"}], "brand_name": "Revonto", "product_id": "78670-003_e2a8cdae-f253-4b7a-b9ab-c66506106aef", "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": "78670-003", "generic_name": "dantrolene sodium", "labeler_name": "USWM, LLC", "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"}