Hydromorphone Injectable Solution

Brand(s)
Dilaudid
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Purdue Pharma Lp (2015-09-04)
Oldest Current Product
1926-01-01
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\HYDROMORPHONE
FDAOB
INJECTION\INJECTION\HYDROMORPHONE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HYDROMORPHONE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION, SOLUTION\HYDROMORPHONE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\HYDROMORPHONE HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION\HYDROMORPHONE HYDROCHLORIDE
PARENTERAL\INJECTION\HYDROMORPHONE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\HYDROMORPHONE
INTRAMUSCULAR\INJECTION, SOLUTION\HYDROMORPHONE
INTRAMUSCULAR\INJECTION\HYDROMORPHONE
INTRAVENOUS\INJECTION, SOLUTION\HYDROMORPHONE
PARENTERAL\INJECTION\HYDROMORPHONE

product(s) by strength(s)

hydromorphone hydrochloride 0.1 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330004UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2014-08-21HYDROMORPHONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONe6814a56-e010-4d93-a5fd-c4d8a878aa26

hydromorphone hydrochloride 0.2 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330002UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2010-08-23, 2011-10-17, 2013-04-04, 2015-04-01HYDROMORPHONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION053a62b8-92c2-47e8-bbdd-ff2ec4d75dc7, 44a184b2-fe1d-4b7b-ba66-a9ca57a3e875, 839962c0-4186-4ea8-9fd7-7048c2212e7b, 91ec07e1-8fc6-4eda-807e-2edc2e69411e, ac0d4ad4-a265-4690-bdfe-ab27b64e6b97

hydromorphone hydrochloride 0.4 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330145UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2014-08-13HYDROMORPHONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTIONc57b413c-18e8-47b7-aff0-879e6d39693d, ced003dc-3b0d-4e95-8695-77f8bee5a674

hydromorphone hydrochloride 0.5 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1525330005UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2012-01-18, 2013-10-11, 2014-08-13HYDROMORPHONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION55c85ab0-57d5-4820-b6b0-1d0e3381571c, a5d20cb8-5e51-4149-a5c9-d0b016c13e05, c4a6f07e-f242-4d25-be44-743b185783a1

hydromorphone hydrochloride 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004092552NDAHospira, Inc.2011-12-01HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA200403e9c9ef18-7dfc-4322-b2fc-29b934c30f8b
2590110441DilaudidNDAPurdue Pharma Lp1926-01-012017-02-01HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA019034c88f81ac-1643-4c08-ae2c-63cbe956db7e

hydromorphone hydrochloride 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1004092634Hospira, Inc.HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION3832ede8-d3fc-455d-ecab-3b77be5869f5
2590110446DilaudidNDAPurdue Pharma Lp1984-01-112016-07-01HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA019034c88f81ac-1643-4c08-ae2c-63cbe956db7e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007030018ANDATeva Parenteral Medicines, Inc2011-01-18HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA078591f0b78db9-a38c-41bb-8233-5e93f7f18c5c
2007030110ANDATeva Parenteral Medicines, Inc2011-01-18HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA078591f0b78db9-a38c-41bb-8233-5e93f7f18c5c
3007030113ANDATeva Parenteral Medicines, Inc2011-01-18HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA078591f0b78db9-a38c-41bb-8233-5e93f7f18c5c
4174780540ANDAAkorn2010-05-15HYDROMORPHONE HYDROCHLORIDEPARENTERALINJECTIONANDA0782284d33b072-0755-4b8c-9558-2551306756a3

hydromorphone hydrochloride 2 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1006410121UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1972-01-01HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTIONb325028e-0722-4c8c-9fdb-ab6fb0dc460c
2006412341UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1972-01-01HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTIONb325028e-0722-4c8c-9fdb-ab6fb0dc460c
3525330146UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2014-08-13, 2014-08-20HYDROMORPHONE HYDROCHLORIDEINTRAVENOUSINJECTION, SOLUTION42088b45-49ef-4cb5-a006-8b9a70c6969f, 8d06f43f-78aa-4008-9fa3-60e4cf19d9e8

hydromorphone hydrochloride 4 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092540NDAHospira, Inc.2011-12-01HYDROMORPHONE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONNDA200403e9c9ef18-7dfc-4322-b2fc-29b934c30f8b

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1ANDA074317HYDROMORPHONE HYDROCHLORIDETrueWATSON LABORATORIES INC1995-08-23ANDA074317_001Hydromorphone Prefilled Syringe
2ANDA074598HYDROMORPHONE HYDROCHLORIDEHOSPIRA INC1997-06-19ANDA074598_001Hydromorphone Prefilled Syringe
3ANDA076444HYDROMORPHONE HYDROCHLORIDEBARR LABORATORIES INC2003-04-25ANDA076444_001Hydromorphone Prefilled Syringe
4ANDA078228HYDROMORPHONE HYDROCHLORIDEAKORN INC2010-04-14ANDA078228_001Hydromorphone Prefilled Syringe
5ANDA078261HYDROMORPHONE HYDROCHLORIDEAKORN INC2010-04-14ANDA078261_001Hydromorphone Prefilled Syringe
6ANDA078591HYDROMORPHONE HYDROCHLORIDEHOSPIRA INC2008-06-17ANDA078591_001Hydromorphone Prefilled Syringe
7NDA019034DILAUDIDPURDUE PHARMACEUTICAL PRODUCTS LP1984-01-11p6589960, SUBSTANCENDA019034_001, NDA019034_002, NDA019034_003, NDA019034_004, NDA019034_005Hydromorphone Prefilled Syringe
8NDA200403HYDROMORPHONE HYDROCHLORIDEHOSPIRA INC2011-12-01NDA200403_001, NDA200403_002, NDA200403_003Hydromorphone Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074317_001discontinuedHYDROMORPHONE HYDROCHLORIDE (10MG/ML)INJECTIONFalse1995-08-23HYDROMORPHONE HYDROCHLORIDE
2ANDA074598_001RXHYDROMORPHONE HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP1997-06-19HYDROMORPHONE HYDROCHLORIDE
3ANDA076444_001RXHYDROMORPHONE HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2003-04-25HYDROMORPHONE HYDROCHLORIDE
4ANDA078228_001RXHYDROMORPHONE HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2010-04-14HYDROMORPHONE HYDROCHLORIDE
5ANDA078261_001RXHYDROMORPHONE HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2010-04-14HYDROMORPHONE HYDROCHLORIDE
6ANDA078591_001RXHYDROMORPHONE HYDROCHLORIDE (10MG/ML)INJECTIONFalseAP2008-06-17HYDROMORPHONE HYDROCHLORIDE
7NDA019034_001RXHYDROMORPHONE HYDROCHLORIDE (10MG/ML)INJECTIONTrueAP1984-01-11DILAUDID
8NDA019034_002discontinuedHYDROMORPHONE HYDROCHLORIDE (250MG/VIAL)INJECTIONFalse1994-08-04DILAUDID
9NDA019034_003RXHYDROMORPHONE HYDROCHLORIDE (1MG/ML)INJECTIONTrueAP2009-04-30DILAUDID
10NDA019034_004RXHYDROMORPHONE HYDROCHLORIDE (2MG/ML)INJECTIONTrueAP2009-04-30DILAUDID
11NDA019034_005RXHYDROMORPHONE HYDROCHLORIDE (4MG/ML)INJECTIONTrueAP2009-04-30DILAUDID
12NDA200403_001RXHYDROMORPHONE HYDROCHLORIDE (1MG/ML)INJECTIONFalseAP2011-12-01HYDROMORPHONE HYDROCHLORIDE
13NDA200403_002RXHYDROMORPHONE HYDROCHLORIDE (2MG/ML)INJECTIONFalseAP2011-12-01HYDROMORPHONE HYDROCHLORIDE
14NDA200403_003RXHYDROMORPHONE HYDROCHLORIDE (4MG/ML)INJECTIONFalseAP2011-12-01HYDROMORPHONE HYDROCHLORIDE

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1053a62b8-92c2-47e8-bbdd-ff2ec4d75dc7 (view SPL)Hydromorphone HCl 0.2 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2015-03-254525330002
23832ede8-d3fc-455d-ecab-3b77be5869f5 (view SPL)These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION, USP (HIGH POTENCY) safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION, USP (HIGH POTENCY).HYDROMORPHONE hydrochloride injection, USP (high potency) CIIFor intravenous, intramuscular and subcutaneous useInitial U.S. Approval: January 1984prescriptionHuman PrescriptionHospira, Inc.2015-06-2213004092634
33b77a8fb-e08b-470b-a64e-c824f21d4434 (view SPL)Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 50 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-03-236525330006
43ca76218-94ab-4a78-a950-f190cb703b5c (view SPL)Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2015-03-232525330006
542088b45-49ef-4cb5-a006-8b9a70c6969f (view SPL)Hydromorphone HCl 2 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2014-08-131525330146
644a184b2-fe1d-4b7b-ba66-a9ca57a3e875 (view SPL)Hydromorphone HCl 0.2 mg/mL in 0.9% Sodium Chloride 30 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-03-166525330002
7467c62b6-8ec1-4b72-8987-c32b8a3400a6 (view SPL)Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, MedNetprescriptionHuman PrescriptionCantrell Drug Company2015-03-2318525330006
84d33b072-0755-4b8c-9558-2551306756a3 (view SPL)These highlights do not include all the information needed to use hydromorphone hydrochloride injection [high potency formulation (HPF)] safely and effectively. See full prescribing information for Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]Hydromorphone Hydrochloride Injection, USP[high potency formulation (HPF)] CIIFor intravenous, intramuscular and subcutaneous use Initial U.S. Approval: January 1984prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-02-165174780540
955c85ab0-57d5-4820-b6b0-1d0e3381571c (view SPL)Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2014-05-277525330005
106b179346-de7b-49c0-8cc0-48f5c0a26ac9 (view SPL)Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 100 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-03-305525330006
117122ccea-f35c-4816-b90a-6f12fdc808dd (view SPL)Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 1 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-03-234525330006
12839962c0-4186-4ea8-9fd7-7048c2212e7b (view SPL)Hydromorphone HCl 0.2 mg/mL in 0.9% Sodium Chloride 100 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-03-307525330002
138d06f43f-78aa-4008-9fa3-60e4cf19d9e8 (view SPL)Hydromorphone HCl 2 mg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2014-08-201525330146
1491ec07e1-8fc6-4eda-807e-2edc2e69411e (view SPL)Hydromorphone HCl 0.2 mg/mL in 0.9% Sodium Chloride 50 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-03-175525330002
1598dac991-9545-40be-97ba-fde03fca6474 (view SPL)Hydromorphone HCl 10 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2014-08-132525330008
16a5d20cb8-5e51-4149-a5c9-d0b016c13e05 (view SPL)Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 1 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-05-023525330005
17ac0d4ad4-a265-4690-bdfe-ab27b64e6b97 (view SPL)Hydromorphone HCl 0.2 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, MedNetprescriptionHuman PrescriptionCantrell Drug Company2015-03-1711525330002
18ae5a48e7-05c4-495d-8e72-287d7a4edd98 (view SPL)Hydromorphone HCl 10 mg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2014-08-131525330008
19b325028e-0722-4c8c-9fdb-ab6fb0dc460c (view SPL)HYDROMORPHONE HYDROCHLORIDE INJECTION, USP CIIRx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.2011-07-015006410121, 006412341
20c4a6f07e-f242-4d25-be44-743b185783a1 (view SPL)Hydromorphone HCl 0.5 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2014-08-132525330005
21c57b413c-18e8-47b7-aff0-879e6d39693d (view SPL)Hydromorphone HCl 0.4 mg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2014-08-131525330145
22c88f81ac-1643-4c08-ae2c-63cbe956db7e (view SPL)These highlights do not include all the information needed to use DILAUDID INJECTION and DILAUDID-HP INJECTION safely and effectively. See full prescribing information for DILAUDID INJECTION and DILAUDID-HP INJECTION. DILAUDID INJECTION (hydromorphone hydrochloride) DILAUDID-HP INJECTION (hydromorphone hydrochloride) CII For intravenous, intramuscular and subcutaneous use Initial U.S. Approval: January 1984prescriptionHuman PrescriptionPurdue Pharma LpAPI MANUFACTURE, MANUFACTURE2015-09-049590110441, 590110446, 590110442, 590110444, 590110445
23ced003dc-3b0d-4e95-8695-77f8bee5a674 (view SPL)Hydromorphone HCl 0.4 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2014-08-131525330145
24d0978b31-cdc9-46a5-9e29-5ea91031e4ca (view SPL)Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 50 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-05-112525330006
25daa5485b-8ee2-414b-9ed5-081bc7149ef5 (view SPL)Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL Monoject Syringe BarrelprescriptionHuman PrescriptionCantrell Drug Company2014-05-275525330006
26e6814a56-e010-4d93-a5fd-c4d8a878aa26 (view SPL)Hydromorphone HCl 0.4 mg/mL in 0.9% Sodium Chloride 30 mL PCA VialprescriptionHuman PrescriptionCantrell Drug Company2014-08-131525330004
27e9c9ef18-7dfc-4322-b2fc-29b934c30f8b (view SPL)These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION, USP safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION, USP. HYDROMORPHONE HYDROCHLORIDE INJECTION, USP for intravenous, intramuscular and subcutaneous route, CII Initial U.S. Approval: 1984prescriptionHuman PrescriptionHospira, Inc.2015-08-2712004092540, 004092552, 004091283, 004091304, 004091312, 004093356, 004093365Hydromorphone Prefilled Syringe
28f0b78db9-a38c-41bb-8233-5e93f7f18c5c (view SPL)HydromorphoneHydrochloride Injection, USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2013-01-233007030018, 007030110, 007030113

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