FDA.reportPublic FDA data

NDC 82774-001-01 - Dantrolene Sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
82774-001
Requested NDC
82774-001-01
Package NDCs from labels
82774-001-01
Manufacturer
Shanghai Renqu Pharmaceutical Science & Technology Co., Ltd.
Effective date
2022-06-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dantrolene SodiumShanghai Renqu Pharmaceutical Science & Technology Co., Ltd.2022-06-18BULK INGREDIENT - ANIMAL DRUG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82774-001-01Dantrolene Sodium25 kg in 1 DRUMPOWDER251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82774-001DANTROLENE SODIUM POWDER [SHANGHAI RENQU PHARMACEUTICAL SCIENCE & TECHNOLOGY CO., LTD.]11 package rows20220620_d8089d1d-dadc-4b07-925f-dd4f8eddbe15.zip

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 ยท 19 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 reactionsExact identifier
unii: 287M0347EV
dantrolene sodiumDANTROLENE SODIUMPar Health USA, LLC11689f56-15e0-4350-b53f-ae96e5994fea2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMMajor Pharmaceuticals90414d2f-7b2c-47f9-a096-2e7b7dd052de2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMAmneal Pharmaceuticals of New York LLCc3c45b27-f786-456e-95d6-2e38ef36190a2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
DantriumDANTROLENE SODIUMPar Health USA, LLC4df35098-8702-46be-ac67-30cfdf1aa5702026-03-10Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
RevontoDANTROLENE SODIUMProPharma Distribution3edcfad5-00ad-7587-e063-6394a90addf32025-12-18Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMCardinal Health 107, LLC5ec05285-4cbd-49c4-951b-86829da6f5872025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMAvPAKbd1ef298-2219-2a01-e053-2995a90abb082025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
DantroleneDANTROLENEHikma Pharmaceuticals USA Inc.ab0efc75-0598-4f4e-91ad-6195bb2661fe2024-12-11Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
RYANODEX dantrolene sodiumDANTROLENE SODIUMEagle Pharmaceuticals, Inc.8f7b3ac0-604d-4c78-b545-5e0f8ea3d6982024-10-30Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMAmerican Health Packaging5162f162-8454-4c07-9670-682df7c30b0f2024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepacke432a760-40b8-4efa-af2b-18e027ac5ae42024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepackdbf78d48-71a6-4a9b-bf31-e710b78944f22024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepackbd218ddb-c133-438c-9545-321ae4b524402024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackf6ce8871-f1a5-43ea-9250-1999fb69b8352024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
RevontoDANTROLENE SODIUMUSWM, LLCf1650487-32bd-4017-b9c2-b38829a531af2024-05-14Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackdb715aef-83ca-4608-befa-8288ab4adeea2024-03-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackc83daa7b-f2c6-418f-a242-fe2d8cad40812023-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV
Dantrolene SodiumDANTROLENE SODIUMElite Laboratories, Inc.e637fb20-6a17-4522-810a-990bf14097322019-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 287M0347EV

Reported adverse events (FAERS/openFDA)#

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