Dantrolene Oral Capsule

Brand(s)
Dantrium
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Inc. (2013-07-18)
Oldest Current Product
2005-03-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\DANTROLENE
FDAOB
ORAL\CAPSULE\DANTROLENE SODIUM
SPL Active
ORAL\CAPSULE\DANTROLENE SODIUM
SPL Moiety
ORAL\CAPSULE\DANTROLENE

product(s) by strength(s)

dantrolene sodium 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230126DantriumNDAPar Pharmaceutical Inc.2008-08-01DANTROLENE SODIUMORALCAPSULENDA01744357b4eec1-49e1-432c-95ae-0fe36e32d64b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001154433ANDAGlobal Pharmaceuticals2005-03-01DANTROLENE SODIUMORALCAPSULEANDA076856c3c45b27-f786-456e-95d6-2e38ef36190a

dantrolene sodium 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230124DantriumNDAPar Pharmaceutical Inc.2008-08-01DANTROLENE SODIUMORALCAPSULENDA01744357b4eec1-49e1-432c-95ae-0fe36e32d64b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001154411ANDAGlobal Pharmaceuticals2005-03-01DANTROLENE SODIUMORALCAPSULEANDA076856c3c45b27-f786-456e-95d6-2e38ef36190a
2420230144NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2013-04-08DANTROLENE SODIUMORALCAPSULENDA017443144ac2eb-cfdd-4334-b04e-54b705122b7f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680840300ANDAAmerican Health Packaging2008-09-25DANTROLENE SODIUMORALCAPSULE001154411ANDA0768565162f162-8454-4c07-9670-682df7c30b0f
2681511520ANDACarilion Materials Management2005-03-01DANTROLENE SODIUMORALCAPSULE001154411ANDA076856ade5fe9c-7601-490a-ac6f-31e63fbd3f8d

dantrolene sodium 50 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230125DantriumNDAPar Pharmaceutical Inc.2008-08-01DANTROLENE SODIUMORALCAPSULENDA01744357b4eec1-49e1-432c-95ae-0fe36e32d64b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001154422ANDAGlobal Pharmaceuticals2005-03-01DANTROLENE SODIUMORALCAPSULEANDA076856c3c45b27-f786-456e-95d6-2e38ef36190a
2420230145NDA AUTHORIZED GENERICPar Pharmaceutical Inc.2013-04-08DANTROLENE SODIUMORALCAPSULENDA017443144ac2eb-cfdd-4334-b04e-54b705122b7f

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076686DANTROLENE SODIUMELITE LABORATORIES INC2005-10-24ANDA076686_001, ANDA076686_002, ANDA076686_003
2ANDA076856DANTROLENE SODIUMIMPAX LABORATORIES INC2005-03-01ANDA076856_001, ANDA076856_002, ANDA076856_003
3NDA017443DANTRIUMPAR STERILE PRODUCTS LLCNDA017443_001, NDA017443_002, NDA017443_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076686_001RXDANTROLENE SODIUM (25MG)ORALCAPSULEFalseAB2005-10-24DANTROLENE SODIUM
2ANDA076686_002RXDANTROLENE SODIUM (50MG)ORALCAPSULEFalseAB2005-10-24DANTROLENE SODIUM
3ANDA076686_003RXDANTROLENE SODIUM (100MG)ORALCAPSULEFalseAB2005-10-24DANTROLENE SODIUM
4ANDA076856_001RXDANTROLENE SODIUM (25MG)ORALCAPSULEFalseAB2005-03-01DANTROLENE SODIUM
5ANDA076856_002RXDANTROLENE SODIUM (50MG)ORALCAPSULEFalseAB2005-03-01DANTROLENE SODIUM
6ANDA076856_003RXDANTROLENE SODIUM (100MG)ORALCAPSULEFalseAB2005-03-01DANTROLENE SODIUM
7NDA017443_001RXDANTROLENE SODIUM (25MG)ORALCAPSULEFalseABDANTRIUM
8NDA017443_002RXDANTROLENE SODIUM (100MG)ORALCAPSULETrueABDANTRIUM
9NDA017443_003RXDANTROLENE SODIUM (50MG)ORALCAPSULEFalseABDANTRIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1144ac2eb-cfdd-4334-b04e-54b705122b7f (view SPL)Dantrolene Sodium CapsulesprescriptionHuman PrescriptionPar Pharmaceutical Inc.2013-07-182420230144, 420230145
25162f162-8454-4c07-9670-682df7c30b0f (view SPL)DANTROLENE SODIUM CAPSULESprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-102680840300
357b4eec1-49e1-432c-95ae-0fe36e32d64b (view SPL)Dantrium (dantrolene sodium) capsulesprescriptionHuman PrescriptionPar Pharmaceutical Inc.2012-07-256420230124, 420230125, 420230126
4ade5fe9c-7601-490a-ac6f-31e63fbd3f8d (view SPL)DANTROLENE SODIUM CAPSULES, 25 mg, 50 mg and 100 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-11-152681511520
5c3c45b27-f786-456e-95d6-2e38ef36190a (view SPL)DANTROLENE SODIUM CAPSULES, 25 mg, 50 mg and 100 mgprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2013-11-156001154411, 001154422, 001154433

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII