Hydromorphone Oral Tablet

Brand(s)
Dilaudid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Purdue Pharma Lp (2013-06-17)
Oldest Current Product
1926-01-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\HYDROMORPHONE
FDAOB
ORAL\TABLET\HYDROMORPHONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\HYDROMORPHONE HYDROCHLORIDE
ORAL\TABLET\HYDROMORPHONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\HYDROMORPHONE
ORAL\TABLET\HYDROMORPHONE

product(s) by strength(s)

hydromorphone hydrochloride 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110452DilaudidNDAPurdue Pharma Lp1956-01-01HYDROMORPHONE HYDROCHLORIDEORALTABLETNDA0198923afae8b9-bb24-447a-bc7f-041c8326a438

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004063243ANDAMallinckrodt, Inc.2009-05-14HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA0782734c5c1cc8-c42b-46e3-ad68-8e22f57101f2
2005271353ANDALannett Company, Inc.2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA078439a6c981fb-28f9-4eff-962b-226736f7d0c8
3428580301NDA AUTHORIZED GENERICRhodes Pharmaceuticals L.P.2009-11-23HYDROMORPHONE HYDROCHLORIDEORALTABLETNDA01989237565441-0d95-4743-a695-d7b3326f58a1

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900827ANDAStat Rx Usa Llc2009-05-14HYDROMORPHONE HYDROCHLORIDEORALTABLET004063243ANDA078273471f8bb8-c23f-49f2-8685-2b2aa514e076
2353560514DilaudidNDALake Erie Medical Dba Quality Care Products Llc2011-12-01HYDROMORPHONE HYDROCHLORIDEORALTABLET590110452NDA01989239003b2e-be25-402e-b755-96c7b41a7639
3353560630ANDALake Erie Medical Dba Quality Care Products Llc2009-05-14HYDROMORPHONE HYDROCHLORIDEORALTABLET004063243ANDA0782733b0f88f3-0fa5-4fd8-8fdf-3e3236a6b4a1
4353560816ANDALake Erie Medical Dba Quality Care Products Llc2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLET005271353ANDA078439efc12b44-69ef-4d03-b9bb-09a934eb81c8
5425490594ANDAStat Rx Usa Llc2007-09-19HYDROMORPHONE HYDROCHLORIDEORALTABLET004063243ANDA078273d42f2e61-f65a-42f2-bec5-2d248d788e78
6430630051ANDAPd-Rx Pharmaceuticals, Inc.2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLET005271353ANDA0784391e55260d-7c0d-45a2-9e2f-e829f25b60b7
7529590420ANDAH.J. Harkins Company, Inc.2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLET005271353ANDA0784397c122909-cedb-469a-99de-a44bcd51238d
8548683165ANDAPhysicians Total Care, Inc.2004-09-20HYDROMORPHONE HYDROCHLORIDEORALTABLET, FILM COATED004063243ANDA0782732115e839-c64f-4a6f-9001-bf91ddd89630
9636294284NDA AUTHORIZED GENERICBryant Ranch Prepack2009-11-23HYDROMORPHONE HYDROCHLORIDEORALTABLET428580301NDA0198922427814c-f32b-8ac5-99b8-5e886fd2d001
10680840423ANDAAmerican Health Packaging2013-07-17HYDROMORPHONE HYDROCHLORIDEORALTABLET005271353ANDA0784398930c2ef-7c1a-4d6e-b44b-ed91d0686d37

hydromorphone hydrochloride 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110454DilaudidNDAPurdue Pharma Lp1956-01-01HYDROMORPHONE HYDROCHLORIDEORALTABLETNDA0198923afae8b9-bb24-447a-bc7f-041c8326a438

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540264ANDARoxane Laboratories, Inc2009-07-29HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA074597cc574063-6ede-4da7-82c4-7450c92b229b
2004063244ANDAMallinckrodt, Inc.2009-05-14HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA0782734c5c1cc8-c42b-46e3-ad68-8e22f57101f2
3005271354ANDALannett Company, Inc.2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA078439a6c981fb-28f9-4eff-962b-226736f7d0c8
4428580302NDA AUTHORIZED GENERICRhodes Pharmaceuticals L.P.2009-11-23HYDROMORPHONE HYDROCHLORIDEORALTABLETNDA01989237565441-0d95-4743-a695-d7b3326f58a1

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560007DilaudidNDALake Erie Medical Dba Quality Care Products Llc1956-01-01HYDROMORPHONE HYDROCHLORIDEORALTABLET590110454NDA0198928fe59c4d-c80b-4668-a04e-0dfd2b441f29
2353560815ANDALake Erie Medical Dba Quality Care Products Llc2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLET005271354ANDA078439efc12b44-69ef-4d03-b9bb-09a934eb81c8
3425490574ANDAStat Rx Usa Llc2007-09-19HYDROMORPHONE HYDROCHLORIDEORALTABLET004063244ANDA078273d42f2e61-f65a-42f2-bec5-2d248d788e78
4499990835ANDALake Erie Medical Dba Quality Care Products Llc2011-11-29HYDROMORPHONE HYDROCHLORIDEORALTABLET004063244ANDA0782737db1d180-8419-462b-a454-5dd01e4b7795, c5779977-a604-4010-a79e-11b83e216814
5529590408ANDAH.J. Harkins Company, Inc.2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLET005271354ANDA0784397c122909-cedb-469a-99de-a44bcd51238d
6548684969ANDAPhysicians Total Care, Inc.2004-01-07HYDROMORPHONE HYDROCHLORIDEORALTABLET, FILM COATED004063244ANDA0782732115e839-c64f-4a6f-9001-bf91ddd89630
7551541610DilaudidNDACardinal Health1926-01-01HYDROMORPHONE HYDROCHLORIDEORALTABLET590110454NDA0198924daba60f-af60-4c7e-916e-f2ad7e7532c5
8636293798NDABryant Ranch Prepack2009-11-23HYDROMORPHONE HYDROCHLORIDEORALTABLET428580302NDA0198924a63f06d-a99b-96d5-c55d-ff03ed82943a
9680840472ANDAAmerican Health Packaging2013-07-17HYDROMORPHONE HYDROCHLORIDEORALTABLET005271354ANDA0784398930c2ef-7c1a-4d6e-b44b-ed91d0686d37

hydromorphone hydrochloride 8 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110458DilaudidNDAPurdue Pharma Lp1956-01-01HYDROMORPHONE HYDROCHLORIDEORALTABLETNDA0198923afae8b9-bb24-447a-bc7f-041c8326a438

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540265ANDARoxane Laboratories, Inc2009-07-29HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA074597cc574063-6ede-4da7-82c4-7450c92b229b
2004063249ANDAMallinckrodt, Inc.2009-05-14HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA0768554c5c1cc8-c42b-46e3-ad68-8e22f57101f2
3005271355ANDALannett Company, Inc.2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA077471a6c981fb-28f9-4eff-962b-226736f7d0c8
4428580303NDA AUTHORIZED GENERICRhodes Pharmaceuticals L.P.2009-11-23HYDROMORPHONE HYDROCHLORIDEORALTABLETNDA01989237565441-0d95-4743-a695-d7b3326f58a1
5512240102ANDATagi Pharma, Inc.2012-03-09HYDROMORPHONE HYDROCHLORIDEORALTABLETANDA076723d596ee4f-71e7-4072-95fa-98f5ee261ff1

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900774NDA AUTHORIZED GENERICStat Rx Usa Llc2009-11-23HYDROMORPHONE HYDROCHLORIDEORALTABLET428580303NDA01989286638efd-9eb9-440e-b48b-b1bd52ccbc61
2353560814ANDALake Erie Medical Dba Quality Care Products Llc2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLET005271355ANDA077471efc12b44-69ef-4d03-b9bb-09a934eb81c8
3499990836ANDALake Erie Medical Dba Quality Care Products Llc2010-04-26HYDROMORPHONE HYDROCHLORIDEORALTABLET004063249ANDA07685548b03745-b36e-4a77-82c8-a55af7973e7b
4529590413ANDAH.J. Harkins Company, Inc.2009-12-09HYDROMORPHONE HYDROCHLORIDEORALTABLET005271355ANDA0774717c122909-cedb-469a-99de-a44bcd51238d
5548684598ANDAPhysicians Total Care, Inc.2002-02-06HYDROMORPHONE HYDROCHLORIDEORALTABLET, FILM COATED004063249ANDA0768552115e839-c64f-4a6f-9001-bf91ddd89630
6636294521ANDABryant Ranch Prepack2009-07-29HYDROMORPHONE HYDROCHLORIDEORALTABLET000540265ANDA07459701186e33-891d-436b-ae0c-ca98aba227d6
7680840798ANDAAmerican Health Packaging2014-08-14HYDROMORPHONE HYDROCHLORIDEORALTABLET005271355ANDA0784398930c2ef-7c1a-4d6e-b44b-ed91d0686d37
8680940852ANDAPrecision Dose Inc.2014-02-17HYDROMORPHONE HYDROCHLORIDEORALTABLET512240102ANDA076723d5bafaec-9a75-4995-bc1d-8a6af18d1bce

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA074597HYDROMORPHONE HYDROCHLORIDEROXANE LABORATORIES INC1998-07-29ANDA074597_001, ANDA074597_003
2ANDA076723HYDROMORPHONE HYDROCHLORIDEELITE LABORATORIES INC2005-10-18ANDA076723_001
3ANDA076855HYDROMORPHONE HYDROCHLORIDEMALLINCKRODT INC2004-12-23ANDA076855_001
4ANDA077311HYDROMORPHONE HYDROCHLORIDETrueNESHER PHARMACEUTICALS USA LLC2005-11-09ANDA077311_001, ANDA077311_002, ANDA077311_003
5ANDA077471HYDROMORPHONE HYDROCHLORIDELANNETT HOLDINGS INC2009-12-09ANDA077471_001
6ANDA078273HYDROMORPHONE HYDROCHLORIDEMALLINCKRODT INC2007-09-19ANDA078273_001, ANDA078273_002
7ANDA078439HYDROMORPHONE HYDROCHLORIDELANNETT HOLDINGS INC2009-12-09ANDA078439_001, ANDA078439_002
8NDA019892DILAUDIDPURDUE PHARMACEUTICAL PRODUCTS LP1992-12-07p6589960, SUBSTANCENDA019892_001, NDA019892_002, NDA019892_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074597_001RXHYDROMORPHONE HYDROCHLORIDE (8MG)ORALTABLETFalseAB1998-07-29HYDROMORPHONE HYDROCHLORIDE
2ANDA074597_003RXHYDROMORPHONE HYDROCHLORIDE (4MG)ORALTABLETFalseAB2009-05-29HYDROMORPHONE HYDROCHLORIDE
3ANDA076723_001RXHYDROMORPHONE HYDROCHLORIDE (8MG)ORALTABLETFalseAB2005-10-18HYDROMORPHONE HYDROCHLORIDE
4ANDA076855_001RXHYDROMORPHONE HYDROCHLORIDE (8MG)ORALTABLETFalseAB2004-12-23HYDROMORPHONE HYDROCHLORIDE
5ANDA077311_001discontinuedHYDROMORPHONE HYDROCHLORIDE (2MG)ORALTABLETFalse2005-11-09HYDROMORPHONE HYDROCHLORIDE
6ANDA077311_002discontinuedHYDROMORPHONE HYDROCHLORIDE (4MG)ORALTABLETFalse2005-11-09HYDROMORPHONE HYDROCHLORIDE
7ANDA077311_003discontinuedHYDROMORPHONE HYDROCHLORIDE (8MG)ORALTABLETFalse2005-11-09HYDROMORPHONE HYDROCHLORIDE
8ANDA077471_001RXHYDROMORPHONE HYDROCHLORIDE (8MG)ORALTABLETFalseAB2009-12-09HYDROMORPHONE HYDROCHLORIDE
9ANDA078273_001RXHYDROMORPHONE HYDROCHLORIDE (2MG)ORALTABLETFalseAB2007-09-19HYDROMORPHONE HYDROCHLORIDE
10ANDA078273_002RXHYDROMORPHONE HYDROCHLORIDE (4MG)ORALTABLETFalseAB2007-09-19HYDROMORPHONE HYDROCHLORIDE
11ANDA078439_001RXHYDROMORPHONE HYDROCHLORIDE (2MG)ORALTABLETFalseAB2009-12-09HYDROMORPHONE HYDROCHLORIDE
12ANDA078439_002RXHYDROMORPHONE HYDROCHLORIDE (4MG)ORALTABLETFalseAB2009-12-09HYDROMORPHONE HYDROCHLORIDE
13NDA019892_001RXHYDROMORPHONE HYDROCHLORIDE (8MG)ORALTABLETTrueAB1992-12-07DILAUDID
14NDA019892_002RXHYDROMORPHONE HYDROCHLORIDE (4MG)ORALTABLETFalseAB2007-11-09DILAUDID
15NDA019892_003RXHYDROMORPHONE HYDROCHLORIDE (2MG)ORALTABLETFalseAB2007-11-09DILAUDID

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6589960 (view patent)2020-11-09NDA019892, NDA019034, NDA019891, NDA021044Hydromorphone Injectable Solution
Hydromorphone Oral Solution
Hydromorphone Prefilled Syringe

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
101186e33-891d-436b-ae0c-ca98aba227d6 (view SPL)HYDROMORPHONE HYDROCHLORIDE Tablets, USP HYDROMORPHONE HYDROCHLORIDE Oral Solution, USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636294521
21e55260d-7c0d-45a2-9e2f-e829f25b60b7 (view SPL)HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.2009-12-092430630051
32115e839-c64f-4a6f-9001-bf91ddd89630 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-211548683165, 548684598, 548684969
42427814c-f32b-8ac5-99b8-5e886fd2d001 (view SPL)Hydromorphone Hydrochloride Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2009-11-232636294284
537565441-0d95-4743-a695-d7b3326f58a1 (view SPL)Hydromorphone Hydrochloride Oral Solution, USP Hydromorphone Hydrochloride Tablets, USP Rx OnlyprescriptionHuman PrescriptionRhodes Pharmaceuticals L.P.MANUFACTURE2014-04-0810428580301, 428580302, 428580303, 428580304Hydromorphone Oral Solution
639003b2e-be25-402e-b755-96c7b41a7639 (view SPL)Dilaudid (hydromorphone hydrochloride) Oral LiquidDilaudid (hydromorphone hydrochloride) TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, relabel, repack2011-12-013297353560514
73afae8b9-bb24-447a-bc7f-041c8326a438 (view SPL)Dilaudid (hydromorphone hydrochloride) Oral LiquidDilaudid (hydromorphone hydrochloride) TabletsprescriptionHuman PrescriptionPurdue Pharma LpMANUFACTURE2013-06-174590110452, 590110454, 590110458, 590110451Hydromorphone Oral Solution
83b0f88f3-0fa5-4fd8-8fdf-3e3236a6b4a1 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-08-292353560630
9471f8bb8-c23f-49f2-8685-2b2aa514e076 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-05-051165900827
1048b03745-b36e-4a77-82c8-a55af7973e7b (view SPL)Hydromorphone HCL 8mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-10-143477499990836
114a63f06d-a99b-96d5-c55d-ff03ed82943a (view SPL)Hydromorphone Hydrochloride Tablets, USPprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, REPACK2009-10-012636293798
124c5c1cc8-c42b-46e3-ad68-8e22f57101f2 (view SPL)HYDROMORPHONEHYDROCHLORIDE TABLETS USP2 mg, 4 mg, and 8 mg Rx only CIIprescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, MANUFACTURE2014-10-3110004063243, 004063244, 004063249
134daba60f-af60-4c7e-916e-f2ad7e7532c5 (view SPL)Dilaudid (hydromorphone hydrochloride) Oral LiquidDilaudid (hydromorphone hydrochloride) TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2011-01-041551541610
147c122909-cedb-469a-99de-a44bcd51238d (view SPL)HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mgprescriptionHuman PrescriptionH.J. Harkins Company, Inc.ANALYSIS, MANUFACTURE2011-12-082529590408, 529590413, 529590420
157db1d180-8419-462b-a454-5dd01e4b7795 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcanalysis, manufacture, relabel, repack2012-02-063538499990835
1686638efd-9eb9-440e-b48b-b1bd52ccbc61 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-08-231165900774
178930c2ef-7c1a-4d6e-b44b-ed91d0686d37 (view SPL)HYDROMORPHONE HYDROCHLORIDE TABLETS USP CIIprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-09-033680840423, 680840472, 680840798
188fe59c4d-c80b-4668-a04e-0dfd2b441f29 (view SPL)Dilaudid (hydromorphone hydrochloride) Oral LiquidDilaudid (hydromorphone hydrochloride) TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2014-03-21344353560007
19a6c981fb-28f9-4eff-962b-226736f7d0c8 (view SPL)HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mgprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, MANUFACTURE2009-12-092005271353, 005271354, 005271355
20c5779977-a604-4010-a79e-11b83e216814 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcanalysis, manufacture, relabel, repack2011-11-293270499990835
21cc574063-6ede-4da7-82c4-7450c92b229b (view SPL)HYDROMORPHONE HYDROCHLORIDE Tablets, USP HYDROMORPHONE HYDROCHLORIDE Oral Solution, USPprescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-08-109000540264, 000540265, 000540386Hydromorphone Oral Solution
22d42f2e61-f65a-42f2-bec5-2d248d788e78 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-04-172425490574, 425490594
23d596ee4f-71e7-4072-95fa-98f5ee261ff1 (view SPL)Hydromorphone Hydrochloride Tablets, USPCIIprescriptionHuman PrescriptionTagi Pharma, Inc.2012-03-141512240102
24d5bafaec-9a75-4995-bc1d-8a6af18d1bce (view SPL)Hydromorphone HydrochlorideTablets, USPprescriptionHuman PrescriptionPrecision Dose Inc.2014-02-241680940852
25efc12b44-69ef-4d03-b9bb-09a934eb81c8 (view SPL)HYDROMORPHONE HYDROCHLORIDE TABLETS USP, 2 mg, 4 mg, and 8 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-03-151353560814, 353560815, 353560816

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