Fludrocortisone Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Global Pharmaceuticals (2013-11-12)
Oldest Current Product
2002-03-18
License(s)
ANDA
RxNORM
ORAL TABLET\FLUDROCORTISONE
FDAOB
ORAL\TABLET\FLUDROCORTISONE ACETATE
SPL Active
ORAL\TABLET\FLUDROCORTISONE ACETATE
SPL Moiety
ORAL\TABLET\FLUDROCORTISONE

product(s) by strength(s)

fludrocortisone 0.1 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001157033ANDAGlobal Pharmaceuticals2002-03-18FLUDROCORTISONE ACETATEORALTABLETANDA0404314ed382df-f2d5-46a4-a68b-aba807777093
2001431246ANDAWest-Ward Pharmaceutical Corp2011-07-22FLUDROCORTISONE ACETATEORALTABLETANDA091302198278e7-9a6d-4a9a-bb47-3589f35939da
3005550997ANDABarr Laboratories Inc.2003-02-14FLUDROCORTISONE ACETATEORALTABLETANDA040425f5cffa20-9a22-43c5-9e89-3225852c2dfa

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006156562ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2002-03-30FLUDROCORTISONE ACETATEORALTABLET001157033ANDA0404313c007f9a-4cd5-4e74-a633-d55dde1fe903
2422910529ANDAAvkare, Inc.2002-03-18FLUDROCORTISONE ACETATEORALTABLET001157033ANDA0404312e6ee871-d855-44c3-9319-8ea49035521b
3493490556ANDARemedyrepack Inc.2011-10-03FLUDROCORTISONE ACETATEORALTABLET005550997ANDA04042543a616b1-b818-42c7-a2ad-704e6699755b
4502680330ANDAAvpak2011-08-01FLUDROCORTISONE ACETATEORALTABLET001157033ANDA0404312cd3965d-cab9-a97c-db61-7d03ced154f3
5548685446ANDAPhysicians Total Care, Inc.2005-10-06FLUDROCORTISONE ACETATEORALTABLET00115703301ANDA040431bf927cd9-1891-4de4-b4be-743a26363a64
6551546645ANDACardinal Health2008-05-09FLUDROCORTISONE ACETATEORALTABLET680840288ANDA04043189b5687a-6e21-47cd-9c05-d9c9f4f8cf49
7680840288ANDAAmerican Health Packaging2008-05-09FLUDROCORTISONE ACETATEORALTABLET001157033ANDA040431001e72ea-2c9e-468c-90cc-6c347234e2a9

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040425FLUDROCORTISONE ACETATEBARR LABORATORIES INC2003-01-21ANDA040425_001
2ANDA040431FLUDROCORTISONE ACETATEIMPAX LABORATORIES INC2002-03-18ANDA040431_001
3ANDA091302FLUDROCORTISONE ACETATEHIKMA PHARMACEUTICALS2011-07-22ANDA091302_001
4NDA010060FLORINEFTrueCITRON PHARMA LLCNDA010060_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040425_001RXFLUDROCORTISONE ACETATE (0.1MG)ORALTABLETFalseAB2003-01-21FLUDROCORTISONE ACETATE
2ANDA040431_001RXFLUDROCORTISONE ACETATE (0.1MG)ORALTABLETTrueAB2002-03-18FLUDROCORTISONE ACETATE
3ANDA091302_001RXFLUDROCORTISONE ACETATE (0.1MG)ORALTABLETFalseAB2011-07-22FLUDROCORTISONE ACETATE
4NDA010060_001discontinuedFLUDROCORTISONE ACETATE (0.1MG)ORALTABLETFalseFLORINEF

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1001e72ea-2c9e-468c-90cc-6c347234e2a9 (view SPL)FLUDROCORTISONE ACETATE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-142680840288
2198278e7-9a6d-4a9a-bb47-3589f35939da (view SPL)Fludrocortisone Acetate Tablets, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2011-07-262001431246
32cd3965d-cab9-a97c-db61-7d03ced154f3 (view SPL)FLUDROCORTISONE ACETATE TABLETS, USP0.1 mgprescriptionHuman PrescriptionAvpak2014-09-245502680330
42e6ee871-d855-44c3-9319-8ea49035521b (view SPL)FLUDROCORTISONE ACETATE TABLETS, USP0.1 mgprescriptionHuman PrescriptionAvkare, Inc.2015-04-204422910529
53c007f9a-4cd5-4e74-a633-d55dde1fe903 (view SPL)FLUDROCORTISONE ACETATE TABLETS, USP0.1 mgprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-01-244006156562
643a616b1-b818-42c7-a2ad-704e6699755b (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-031493490556
74ed382df-f2d5-46a4-a68b-aba807777093 (view SPL)FLUDROCORTISONE ACETATE TABLETS, USP0.1 mgprescriptionHuman PrescriptionGlobal Pharmaceuticals2013-11-124001157033
889b5687a-6e21-47cd-9c05-d9c9f4f8cf49 (view SPL)FLUDROCORTISONE ACETATE TABLETS, USP0.1 mgprescriptionHuman PrescriptionCardinal HealthREPACK2014-08-054551546645
9bf927cd9-1891-4de4-b4be-743a26363a64 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-09-031548685446
10f5cffa20-9a22-43c5-9e89-3225852c2dfa (view SPL)FLUDROCORTISONE ACETATE TABLETS USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-10-037005550997

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