Hydrocortisone Oral Tablet

Brand(s)
Cortef
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-08-14)
Oldest Current Product
1952-12-15
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\HYDROCORTISONE
FDAOB
ORAL\TABLET\HYDROCORTISONE
SPL Active
ORAL\TABLET\HYDROCORTISONE
SPL Moiety
ORAL\TABLET\HYDROCORTISONE

product(s) by strength(s)

hydrocortisone 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090031CortefNDAPharmacia And Upjohn Company1952-12-15HYDROCORTISONEORALTABLETNDA0086979ce19944-dd88-4a7b-84ca-b07f4ec23bad

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001431253ANDAWest-Ward Pharmaceutical Corp2015-02-23HYDROCORTISONEORALTABLETANDA083365452d7333-69ed-451a-a152-95a644744579
2006033900ANDAQualitest Pharmaceuticals2007-07-16HYDROCORTISONEORALTABLETANDA040761cc6f9187-baa3-46bc-b424-d348be820c50
3545050332ANDALineage Therapeutics Inc2007-03-30HYDROCORTISONEORALTABLETANDA0406462dec7771-ddbf-11e2-a28f-0800200c9a66
4597620074NDA AUTHORIZED GENERICGreenstone Llc2013-02-20HYDROCORTISONEORALTABLETNDA008697bc751403-94f2-4f9d-b533-cf6186a40ceb

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790058ANDAKaiser Foundations Hospitals2010-03-05HYDROCORTISONEORALTABLET006033900ANDA0407612596b87c-de70-4bfa-b2fc-cc5ad47093ce
2680840469ANDAAmerican Health Packaging2011-04-01HYDROCORTISONEORALTABLET006033900ANDA040761fc29adaa-48f1-40d4-a721-307462f3025a

hydrocortisone 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090044CortefNDAPharmacia And Upjohn Company1952-12-15HYDROCORTISONEORALTABLETNDA0086979ce19944-dd88-4a7b-84ca-b07f4ec23bad

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001431254ANDAWest-Ward Pharmaceutical Corp1973-06-18HYDROCORTISONEORALTABLETANDA083365452d7333-69ed-451a-a152-95a644744579
2006033901ANDAQualitest Pharmaceuticals2007-07-16HYDROCORTISONEORALTABLETANDA040761cc6f9187-baa3-46bc-b424-d348be820c50
3009042674ANDAMajor1973-06-18HYDROCORTISONEORALTABLETANDA083365fb8f1024-e2d4-4394-ac45-d807a4caf4af
4545050333ANDALineage Therapeutics Inc2007-03-30HYDROCORTISONEORALTABLETANDA0406462dec7771-ddbf-11e2-a28f-0800200c9a66
5597620075NDA AUTHORIZED GENERICGreenstone Llc2013-02-20HYDROCORTISONEORALTABLETNDA008697bc751403-94f2-4f9d-b533-cf6186a40ceb

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900990ANDAStat Rx Usa Llc1973-06-18HYDROCORTISONEORALTABLET001431254ANDA0833654e16f4eb-5bd1-4143-9bf8-d852175a598a
2430630386ANDAPd-Rx Pharmaceuticals, Inc.1973-06-18HYDROCORTISONEORALTABLET001431254ANDA0833654e0fa685-b7fd-49a0-81e5-73fc4d602443
3548681743ANDAPhysicians Total Care, Inc.2007-07-05HYDROCORTISONEORALTABLET001431252ANDA0833658880efc2-b2ae-4a2a-864e-9ca70d42cf28
4604290262ANDAGolden State Medical Supply, Inc.1973-06-18HYDROCORTISONEORALTABLET001431252ANDA083365006f20d3-e724-4c55-be41-a5b23d6b638d
5680840930ANDAAmerican Health Packaging2015-03-01, 2015-10-01HYDROCORTISONEORALTABLET006033901ANDA040761059d7b92-7e47-4e93-9785-9fe6da441246, fc29adaa-48f1-40d4-a721-307462f3025a
6681512269ANDACarilion Materials Management2007-03-30HYDROCORTISONEORALTABLET545050333ANDA040646d4d2912e-d1e8-4b40-af88-59c87fa12318

hydrocortisone 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090012CortefNDAPharmacia And Upjohn Company1952-12-15HYDROCORTISONEORALTABLETNDA0086979ce19944-dd88-4a7b-84ca-b07f4ec23bad

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006033899ANDAQualitest Pharmaceuticals2007-07-16HYDROCORTISONEORALTABLETANDA040761cc6f9187-baa3-46bc-b424-d348be820c50
2545050331ANDALineage Therapeutics Inc2007-03-30HYDROCORTISONEORALTABLETANDA0406462dec7771-ddbf-11e2-a28f-0800200c9a66
3597620073NDA AUTHORIZED GENERICGreenstone Llc2013-02-20HYDROCORTISONEORALTABLETNDA008697bc751403-94f2-4f9d-b533-cf6186a40ceb

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790056ANDAKaiser Foundations Hospitals2010-03-05HYDROCORTISONEORALTABLET006033899ANDA0407612596b87c-de70-4bfa-b2fc-cc5ad47093ce
2001790155NDA AUTHORIZED GENERICKaiser Foundations Hospitals2014-09-03HYDROCORTISONEORALTABLET597620073NDA008697bfb94431-4b69-4780-b7d7-e3999e444c39
3680840789ANDAAmerican Health Packaging2014-06-16, 2015-10-01HYDROCORTISONEORALTABLET006033899ANDA040761059d7b92-7e47-4e93-9785-9fe6da441246, fc29adaa-48f1-40d4-a721-307462f3025a
4681514021ANDACarilion Materials Management2007-07-16HYDROCORTISONEORALTABLET006033899ANDA040761532dcc5d-9640-4300-a2f3-ae5655d6a0ba

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040646HYDROCORTISONEAMEDRA PHARMACEUTICALS LLC2007-03-30ANDA040646_001, ANDA040646_002, ANDA040646_003
2ANDA040761HYDROCORTISONEVINTAGE PHARMACEUTICALS LLC2007-07-16ANDA040761_001, ANDA040761_002, ANDA040761_003
3ANDA080344HYDROCORTISONETrueWHITEWORTH TOWNE PAULSEN INCANDA080344_001, ANDA080344_002
4ANDA080355HYDROCORTISONETrueWATSON LABORATORIES INCANDA080355_001
5ANDA080395HYDROCORTISONETruePUREPAC PHARMACEUTICAL COANDA080395_001
6ANDA080568HYDROCORTISONETrueJOHN J FERRANTEANDA080568_001, ANDA080568_002
7ANDA080624HYDROCORTISONETrueELKINS SINN DIV AH ROBINS CO INCANDA080624_001
8ANDA080642HYDROCORTISONETrueSANDOZ INCANDA080642_002
9ANDA080732HYDROCORTISONETrueINWOOD LABORATORIES INC SUB FOREST LABORATORIES INCANDA080732_001
10ANDA080781HYDROCORTISONETrueIMPAX LABORATORIES INCANDA080781_001
11ANDA083140HYDROCORTISONETrueNEXGEN PHARMA INCANDA083140_001
12ANDA083365HYDROCORTISONEHIKMA INTERNATIONAL PHARMACEUTICALS LLCANDA083365_001, ANDA083365_002, ANDA083365_003
13ANDA083999HYDROCORTISONETrueBARR LABORATORIES INCANDA083999_001
14ANDA084243HYDROCORTISONETruePARKE DAVIS DIV WARNER LAMBERT COANDA084243_001
15ANDA084247HYDROCORTISONETruePUREPAC PHARMACEUTICAL COANDA084247_002, ANDA084247_003
16ANDA085070HYDROCORTISONETrueLANNETT CO INCANDA085070_001
17ANDA088539HYDROCORTISONETrueROXANE LABORATORIES INC1984-03-21ANDA088539_001
18NDA008506HYDROCORTONETrueMERCK AND CO INCNDA008506_007, NDA008506_011
19NDA008697CORTEFPHARMACIA AND UPJOHN CONDA008697_001, NDA008697_002, NDA008697_003
20NDA009127CORTRILTruePFIZER LABORATORIES DIV PFIZER INCNDA009127_003, NDA009127_005
21NDA009659HYDROCORTISONETruePANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INCNDA009659_001, NDA009659_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040646_001RXHYDROCORTISONE (5MG)ORALTABLETFalseAB2007-03-30HYDROCORTISONE
2ANDA040646_002RXHYDROCORTISONE (10MG)ORALTABLETFalseAB2007-03-30HYDROCORTISONE
3ANDA040646_003RXHYDROCORTISONE (20MG)ORALTABLETFalseAB2007-03-30HYDROCORTISONE
4ANDA040761_001RXHYDROCORTISONE (5MG)ORALTABLETFalseAB2007-07-16HYDROCORTISONE
5ANDA040761_002RXHYDROCORTISONE (10MG)ORALTABLETFalseAB2007-07-16HYDROCORTISONE
6ANDA040761_003RXHYDROCORTISONE (20MG)ORALTABLETFalseAB2007-07-16HYDROCORTISONE
7ANDA080344_001discontinuedHYDROCORTISONE (10MG)ORALTABLETFalseHYDROCORTISONE
8ANDA080344_002discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
9ANDA080355_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
10ANDA080395_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
11ANDA080568_001discontinuedHYDROCORTISONE (10MG)ORALTABLETFalseHYDROCORTISONE
12ANDA080568_002discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
13ANDA080624_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
14ANDA080642_002discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
15ANDA080732_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
16ANDA080781_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
17ANDA083140_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
18ANDA083365_001RXHYDROCORTISONE (20MG)ORALTABLETFalseABHYDROCORTISONE
19ANDA083365_002RXHYDROCORTISONE (5MG)ORALTABLETFalseAB2015-02-23HYDROCORTISONE
20ANDA083365_003RXHYDROCORTISONE (10MG)ORALTABLETFalseAB2015-02-23HYDROCORTISONE
21ANDA083999_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
22ANDA084243_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
23ANDA084247_002discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
24ANDA084247_003discontinuedHYDROCORTISONE (10MG)ORALTABLETFalse1982-08-31HYDROCORTISONE
25ANDA085070_001discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE
26ANDA088539_001discontinuedHYDROCORTISONE (10MG)ORALTABLETFalse1984-03-21HYDROCORTISONE
27NDA008506_007discontinuedHYDROCORTISONE (10MG)ORALTABLETFalseHYDROCORTONE
28NDA008506_011discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTONE
29NDA008697_001RXHYDROCORTISONE (10MG)ORALTABLETFalseABCORTEF
30NDA008697_002RXHYDROCORTISONE (20MG)ORALTABLETTrueABCORTEF
31NDA008697_003RXHYDROCORTISONE (5MG)ORALTABLETFalseABCORTEF
32NDA009127_003discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseCORTRIL
33NDA009127_005discontinuedHYDROCORTISONE (10MG)ORALTABLETFalseCORTRIL
34NDA009659_001discontinuedHYDROCORTISONE (10MG)ORALTABLETFalseHYDROCORTISONE
35NDA009659_002discontinuedHYDROCORTISONE (20MG)ORALTABLETFalseHYDROCORTISONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1006f20d3-e724-4c55-be41-a5b23d6b638d (view SPL)HYDROCORTISONE TABLETS, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290262
2059d7b92-7e47-4e93-9785-9fe6da441246 (view SPL)HYDROCORTISONE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-251680840789, 680840930
32596b87c-de70-4bfa-b2fc-cc5ad47093ce (view SPL)HYDROCORTISONE TABLETS, USP 5 mg and 10 mgprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-04-211001790056, 001790058
42dec7771-ddbf-11e2-a28f-0800200c9a66 (view SPL)HYDROCORTISONE Tablets, USPLineage TherapeuticsRx onlyprescriptionHuman PrescriptionLineage Therapeutics Inc2013-06-241545050331, 545050332, 545050333
5452d7333-69ed-451a-a152-95a644744579 (view SPL)Hydrocortisone Tablets, USPRev. 02/15Rx OnlyprescriptionHuman PrescriptionWest-Ward Pharmaceutical Corp2015-03-0210001431253, 001431254, 001431252
64e0fa685-b7fd-49a0-81e5-73fc4d602443 (view SPL)HYDROCORTISONE TABLETS USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-08-144430630386
74e16f4eb-5bd1-4143-9bf8-d852175a598a (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-301165900990
8532dcc5d-9640-4300-a2f3-ae5655d6a0ba (view SPL)HYDROCORTISONE TABLETS, USP 5 mg, 10 mg and 20 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-05-292681514021
98880efc2-b2ae-4a2a-864e-9ca70d42cf28 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-12-171548681743
109ce19944-dd88-4a7b-84ca-b07f4ec23bad (view SPL)Cortef hydrocortisone tablets, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-08-146000090012, 000090031, 000090044
11bc751403-94f2-4f9d-b533-cf6186a40ceb (view SPL)Hydrocortisone tablets, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, REPACK2013-09-192597620073, 597620074, 597620075
12bfb94431-4b69-4780-b7d7-e3999e444c39 (view SPL)Hydrocortisone tablets, USPprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-09-111001790155
13cc6f9187-baa3-46bc-b424-d348be820c50 (view SPL)HYDROCORTISONE TABLETS, USP 5 mg, 10 mg and 20 mgprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2013-05-293006033899, 006033900, 006033901
14d4d2912e-d1e8-4b40-af88-59c87fa12318 (view SPL)HYDROCORTISONE Tablets, USP Lineage Therapeutics Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-06-242681512269
15fb8f1024-e2d4-4394-ac45-d807a4caf4af (view SPL)HYDROCORTISONE TABLETS USPprescriptionHuman PrescriptionMajor2012-08-163009042674
16fc29adaa-48f1-40d4-a721-307462f3025a (view SPL)HYDROCORTISONE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-02-112680840469, 680840789, 680840930

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