FDA.reportPublic FDA data

Dantrolene Sodium

Manufacturer
BLUEBAY SHANDONG CO.,LTD
Effective date
2020-12-29
Label type
BULK INGREDIENT
Version
4
Source
full-release
Hydrated at
2026-06-01 02:49:48

Label at a glance#

ProductDantrolene Sodium
Active ingredientDANTROLENE SODIUM
Label structure1 sections

Label contents#

Full prescribing information#

Dantrolene Sodium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e1aa0c0-7e5b-41f6-80ca-71938bc3ba10Product name220170803
d7dbb6a6-7ce7-4878-a62c-772d63bc4c9fProduct name220141210
aa6a0d9e-0b39-aacf-4e4e-ce5e489de585Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73309-172-01Dantrolene Sodium100 g in 1 JARPOWDER1004
73309-172-02Dantrolene Sodium25000 g in 1 DRUMPOWDER250004
73309-172-03Dantrolene Sodium10000 g in 1 DRUMPOWDER100004
73309-172-04Dantrolene Sodium5000 g in 1 DRUMPOWDER50004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73309-172DANTROLENE SODIUM POWDER [BLUEBAY SHANDONG CO.,LTD]44 package rows20201230_46c7fa39-3a8b-4bba-9fa2-3f970defceba.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73309-17273309-172-01, 73309-172-02, 73309-172-03, 73309-172-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
DANTROLENE SODIUM287M0347EVACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DantriumDANTROLENE SODIUMPar Health USA, LLC57b4eec1-49e1-432c-95ae-0fe36e32d64b2026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
dantrolene sodiumDANTROLENE SODIUMPar Health USA, LLC11689f56-15e0-4350-b53f-ae96e5994fea2026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dantrolene sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMMajor Pharmaceuticals90414d2f-7b2c-47f9-a096-2e7b7dd052de2026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMAmneal Pharmaceuticals of New York LLCc3c45b27-f786-456e-95d6-2e38ef36190a2026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
DantriumDANTROLENE SODIUMPar Health USA, LLC4df35098-8702-46be-ac67-30cfdf1aa5702026-03-10Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
RevontoDANTROLENE SODIUMProPharma Distribution3edcfad5-00ad-7587-e063-6394a90addf32025-12-18Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMCardinal Health 107, LLC5ec05285-4cbd-49c4-951b-86829da6f5872025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMAvPAKbd1ef298-2219-2a01-e053-2995a90abb082025-04-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
RYANODEX dantrolene sodiumDANTROLENE SODIUMEagle Pharmaceuticals, Inc.8f7b3ac0-604d-4c78-b545-5e0f8ea3d6982024-10-30Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMAmerican Health Packaging5162f162-8454-4c07-9670-682df7c30b0f2024-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepacke432a760-40b8-4efa-af2b-18e027ac5ae42024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepackdbf78d48-71a6-4a9b-bf31-e710b78944f22024-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepackbd218ddb-c133-438c-9545-321ae4b524402024-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackf6ce8871-f1a5-43ea-9250-1999fb69b8352024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dantrolene sodium
generic name: DANTROLENE SODIUM
RevontoDANTROLENE SODIUMUSWM, LLCf1650487-32bd-4017-b9c2-b38829a531af2024-05-14Warnings, Adverse reactionsName fallback
generic name: DANTROLENE SODIUM
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackdb715aef-83ca-4608-befa-8288ab4adeea2024-03-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dantrolene sodium
generic name: DANTROLENE SODIUM
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackc83daa7b-f2c6-418f-a242-fe2d8cad40812023-10-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dantrolene sodium
generic name: DANTROLENE SODIUM
Dantrolene SodiumDANTROLENE SODIUMElite Laboratories, Inc.e637fb20-6a17-4522-810a-990bf14097322019-12-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dantrolene Sodium
generic name: DANTROLENE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.