Morphine Injectable Solution

Brand(s)
Duramorph, Infumorph
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cantrell Drug Company (2014-10-20)
Oldest Current Product
1971-01-01
License(s)
NDA, ANDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\MORPHINE
FDAOB
INJECTION\INJECTION\MORPHINE SULFATE\rdfq
SPL Active
EPIDURAL\INJECTION, SOLUTION\MORPHINE SULFATE
EPIDURAL\INJECTION\MORPHINE SULFATE
INTRAMUSCULAR\INJECTION\MORPHINE SULFATE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\MORPHINE SULFATE
INTRAVENOUS\INJECTION, SOLUTION\MORPHINE SULFATE
INTRAVENOUS\INJECTION\MORPHINE SULFATE
PARENTERAL\INJECTION\MORPHINE SULFATE
SPL Moiety
EPIDURAL\INJECTION, SOLUTION\MORPHINE
EPIDURAL\INJECTION\MORPHINE
INTRAMUSCULAR\INJECTION\MORPHINE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\MORPHINE
INTRAVENOUS\INJECTION, SOLUTION\MORPHINE
INTRAVENOUS\INJECTION\MORPHINE
PARENTERAL\INJECTION\MORPHINE

product(s) by strength(s)

morphine sulfate 0.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416020DuramorphNDAWest-Ward Pharmaceuticals Corp.1984-09-18MORPHINE SULFATEEPIDURALINJECTIONNDA018565ebb18761-e5c4-4238-bb84-f9549f500210

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093814ANDAHospira, Inc.1992-09-30MORPHINE SULFATEEPIDURALINJECTION, SOLUTIONANDA0735091d181906-f3ec-4222-1883-e61577a3122e
2004094057ANDAHospira, Inc.1988-05-11MORPHINE SULFATEEPIDURALINJECTION, SOLUTIONANDA0718491d181906-f3ec-4222-1883-e61577a3122e

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092028NDAHospira, Inc.1992-10-30MORPHINE SULFATEINTRAVENOUSINJECTION, SOLUTIONNDA0199175b96e83a-d878-4dd5-8480-83a985db4609

morphine sulfate 1 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004092029NDAHospira, Inc.1992-10-30MORPHINE SULFATEINTRAVENOUSINJECTION, SOLUTIONNDA0199165b96e83a-d878-4dd5-8480-83a985db4609
2005481931UNAPPROVED DRUG OTHER MARKETING CATEGORYAmphastar Pharmaceuticals, Inc.1993-06-01MORPHINE SULFATEPARENTERALINJECTION2ee13121-73e0-4207-b6f8-17c073287cf6
3006416019DuramorphNDAWest-Ward Pharmaceuticals Corp.1984-09-18MORPHINE SULFATEEPIDURALINJECTIONNDA018565ebb18761-e5c4-4238-bb84-f9549f500210
4525330059UNAPPROVED DRUG OTHER MARKETING CATEGORYCantrell Drug Company2013-05-01MORPHINE SULFATEINTRAVENOUSINJECTION, SOLUTIONed9ada68-6104-4b33-866d-76ad768a2ec2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004093815ANDAHospira, Inc.1992-09-30MORPHINE SULFATEEPIDURALINJECTION, SOLUTIONANDA0735101d181906-f3ec-4222-1883-e61577a3122e
2004094058ANDAHospira, Inc.1988-05-11MORPHINE SULFATEEPIDURALINJECTION, SOLUTIONANDA0718501d181906-f3ec-4222-1883-e61577a3122e

morphine sulfate 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416039InfumorphNDAWest-Ward Pharmaceuticals Corp.1984-09-18MORPHINE SULFATEEPIDURALINJECTION, SOLUTIONNDA018565db9ac9e3-d761-4a99-9f34-4946ebe8f255
2006416068UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1971-01-01MORPHINE SULFATEINTRAMUSCULARINJECTIONab4a4e86-bc2b-42d5-bc47-1a73f872217b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416127ANDAWest-Ward Pharmaceuticals Corp.2015-06-03MORPHINE SULFATEINTRAVENOUSINJECTIONANDA2057586023606c-150c-40c5-9175-598efe2a56c3

morphine sulfate 15 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1006416071UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1971-01-01MORPHINE SULFATEINTRAMUSCULARINJECTIONab4a4e86-bc2b-42d5-bc47-1a73f872217b
2006416072UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1971-01-01MORPHINE SULFATEINTRAMUSCULARINJECTIONab4a4e86-bc2b-42d5-bc47-1a73f872217b

morphine sulfate 25 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1004091135UNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.1996-03-14MORPHINE SULFATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEcadc3fdb-8edc-44cd-aaea-89e68aaf9a04
2004096179UNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.1991-04-11MORPHINE SULFATEINTRAVENOUSINJECTION, SOLUTIONd473ebeb-960b-4852-82f4-4981469b0f39

morphine sulfate 4 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416125ANDAWest-Ward Pharmaceuticals Corp.2015-06-03MORPHINE SULFATEINTRAVENOUSINJECTIONANDA2057586023606c-150c-40c5-9175-598efe2a56c3

morphine sulfate 5 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004096028NDAHospira, Inc.1992-10-30MORPHINE SULFATEINTRAVENOUSINJECTION, SOLUTIONNDA0199165b96e83a-d878-4dd5-8480-83a985db4609
2006416073UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1971-01-01MORPHINE SULFATEINTRAMUSCULARINJECTIONab4a4e86-bc2b-42d5-bc47-1a73f872217b

morphine sulfate 50 mg/ml injectable solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1004091134UNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.1996-03-14MORPHINE SULFATEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATEcadc3fdb-8edc-44cd-aaea-89e68aaf9a04

morphine sulfate 8 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1006416075UNAPPROVED DRUG OTHER MARKETING CATEGORYWest-Ward Pharmaceuticals Corp.1971-01-01MORPHINE SULFATEINTRAMUSCULARINJECTIONab4a4e86-bc2b-42d5-bc47-1a73f872217b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416126ANDAWest-Ward Pharmaceuticals Corp.2015-06-03MORPHINE SULFATEINTRAVENOUSINJECTIONANDA2057586023606c-150c-40c5-9175-598efe2a56c3

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA071050ASTRAMORPH PFFRESENIUS KABI USA LLC1986-10-07ANDA071050_001Morphine Prefilled Syringe
2ANDA071051ASTRAMORPH PFFRESENIUS KABI USA LLC1986-10-07ANDA071051_001Morphine Prefilled Syringe
3ANDA071052ASTRAMORPH PFFRESENIUS KABI USA LLC1986-10-07ANDA071052_001Morphine Prefilled Syringe
4ANDA071053ASTRAMORPH PFFRESENIUS KABI USA LLC1986-10-07ANDA071053_001Morphine Prefilled Syringe
5ANDA071849MORPHINE SULFATEHOSPIRA INC1988-05-11ANDA071849_001Morphine Prefilled Syringe
6ANDA071850MORPHINE SULFATEHOSPIRA INC1988-05-11ANDA071850_001Morphine Prefilled Syringe
7ANDA073373MORPHINE SULFATETrueWATSON LABORATORIES INC1991-09-30ANDA073373_001Morphine Prefilled Syringe
8ANDA073374MORPHINE SULFATETrueWATSON LABORATORIES INC1991-09-30ANDA073374_001Morphine Prefilled Syringe
9ANDA073375MORPHINE SULFATETrueWATSON LABORATORIES INC1991-09-30ANDA073375_001Morphine Prefilled Syringe
10ANDA073376MORPHINE SULFATETrueWATSON LABORATORIES INC1991-09-30ANDA073376_001Morphine Prefilled Syringe
11ANDA073509MORPHINE SULFATEHOSPIRA INC1992-09-30ANDA073509_001Morphine Prefilled Syringe
12ANDA073510MORPHINE SULFATEHOSPIRA INC1992-09-30ANDA073510_001Morphine Prefilled Syringe
13ANDA205758MORPHINE SULFATEEUROHEALTH INTERNATIONAL SARL2015-05-21ANDA205758_001, ANDA205758_002, ANDA205758_003Morphine Prefilled Syringe
14NDA018565DURAMORPH PFEUROHEALTH INTERNATIONAL SARL1984-09-18NDA018565_001, NDA018565_002, NDA018565_003, NDA018565_004Morphine Prefilled Syringe
15NDA019916MORPHINE SULFATEHOSPIRA INC1992-10-30NDA019916_001, NDA019916_002Morphine Prefilled Syringe
16NDA019917MORPHINE SULFATETrueHOSPIRA INC1992-10-30NDA019917_001Morphine Prefilled Syringe
17NDA019999MORPHINE SULFATEMERIDIAN MEDICAL TECHNOLOGIES INC1990-07-12NDA019999_001Morphine Prefilled Syringe
18NDA020631MORPHINE SULFATETrueMALLINCKRODT CHEMICAL INC1996-07-03NDA020631_001, NDA020631_002Morphine Prefilled Syringe
19NDA202515MORPHINE SULFATEHOSPIRA INC2011-11-14NDA202515_001, NDA202515_002, NDA202515_003, NDA202515_004, NDA202515_005Morphine Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA071050_001RXMORPHINE SULFATE (0.5MG/ML)INJECTIONFalseAP1986-10-07ASTRAMORPH PF
2ANDA071051_001RXMORPHINE SULFATE (0.5MG/ML)INJECTIONFalseAP1986-10-07ASTRAMORPH PF
3ANDA071052_001RXMORPHINE SULFATE (1MG/ML)INJECTIONFalseAP1986-10-07ASTRAMORPH PF
4ANDA071053_001RXMORPHINE SULFATE (1MG/ML)INJECTIONFalseAP1986-10-07ASTRAMORPH PF
5ANDA071849_001RXMORPHINE SULFATE (0.5MG/ML)INJECTIONFalseAP1988-05-11MORPHINE SULFATE
6ANDA071850_001RXMORPHINE SULFATE (1MG/ML)INJECTIONFalseAP1988-05-11MORPHINE SULFATE
7ANDA073373_001discontinuedMORPHINE SULFATE (0.5MG/ML)INJECTIONFalse1991-09-30MORPHINE SULFATE
8ANDA073374_001discontinuedMORPHINE SULFATE (1MG/ML)INJECTIONFalse1991-09-30MORPHINE SULFATE
9ANDA073375_001discontinuedMORPHINE SULFATE (0.5MG/ML)INJECTIONFalse1991-09-30MORPHINE SULFATE
10ANDA073376_001discontinuedMORPHINE SULFATE (1MG/ML)INJECTIONFalse1991-09-30MORPHINE SULFATE
11ANDA073509_001RXMORPHINE SULFATE (0.5MG/ML)INJECTIONFalseAP1992-09-30MORPHINE SULFATE
12ANDA073510_001RXMORPHINE SULFATE (1MG/ML)INJECTIONFalseAP1992-09-30MORPHINE SULFATE
13ANDA205758_001RXMORPHINE SULFATE (4MG/ML)INJECTIONFalseAP2015-05-21MORPHINE SULFATE
14ANDA205758_002RXMORPHINE SULFATE (8MG/ML)INJECTIONFalseAP2015-05-21MORPHINE SULFATE
15ANDA205758_003RXMORPHINE SULFATE (10MG/ML)INJECTIONFalseAP2015-05-21MORPHINE SULFATE
16NDA018565_001RXMORPHINE SULFATE (0.5MG/ML)INJECTIONTrueAP1984-09-18DURAMORPH PF
17NDA018565_002RXMORPHINE SULFATE (1MG/ML)INJECTIONTrueAP1984-09-18DURAMORPH PF
18NDA018565_003RXMORPHINE SULFATE (10MG/ML)INJECTIONTrue1991-07-19DURAMORPH PF
19NDA018565_004RXMORPHINE SULFATE (25MG/ML)INJECTIONTrue1991-07-19DURAMORPH PF
20NDA019916_001RXMORPHINE SULFATE (1MG/ML)INJECTIONTrueAP1992-10-30MORPHINE SULFATE
21NDA019916_002RXMORPHINE SULFATE (5MG/ML)INJECTIONTrue2006-10-27MORPHINE SULFATE
22NDA019917_001discontinuedMORPHINE SULFATE (0.5MG/ML)INJECTIONFalse1992-10-30MORPHINE SULFATE
23NDA019999_001RXMORPHINE SULFATE (15MG/ML)INJECTIONTrue1990-07-12MORPHINE SULFATE
24NDA020631_001discontinuedMORPHINE SULFATE (1MG/ML)INJECTIONFalse1996-07-03MORPHINE SULFATE
25NDA020631_002discontinuedMORPHINE SULFATE (2MG/ML)INJECTIONFalse1996-07-03MORPHINE SULFATE
26NDA202515_001RXMORPHINE SULFATE (2MG/ML)INJECTIONTrue2011-11-14MORPHINE SULFATE
27NDA202515_002RXMORPHINE SULFATE (4MG/ML)INJECTIONTrueAP2011-11-14MORPHINE SULFATE
28NDA202515_003RXMORPHINE SULFATE (8MG/ML)INJECTIONTrueAP2011-11-14MORPHINE SULFATE
29NDA202515_004RXMORPHINE SULFATE (10MG/ML)INJECTIONTrueAP2011-11-14MORPHINE SULFATE
30NDA202515_005RXMORPHINE SULFATE (15MG/ML)INJECTIONTrue2011-11-14MORPHINE SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1093bee1a-a532-4dc1-83df-c0c5c7cdc58a (view SPL)Morphine Sulfate 5 mg/mL in 0.9% Sodium Chloride 30 mL Monoject Syringe BarrelprescriptionHuman PrescriptionCantrell Drug Company2014-04-303525330132
21d181906-f3ec-4222-1883-e61577a3122e (view SPL)MORPHINESulfate Injection, USPprescriptionHuman PrescriptionHospira, Inc.2013-11-0411004093814, 004093815, 004094057, 004094058
32ee13121-73e0-4207-b6f8-17c073287cf6 (view SPL)MORPHINE SULFATE INJECTION, USP CIIprescriptionHuman PrescriptionAmphastar Pharmaceuticals, Inc.2009-12-182005481931
433a1a27e-da5a-449a-bc7b-a702de0afdaa (view SPL)Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride 1 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-05-022525330160
54f2f2f5f-459b-4fb6-ada3-37a4d52af272 (view SPL)MorphineSulfate 1 mg/mL in 0.9% Sodium Chloride 55 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-05-2013525330160
65b96e83a-d878-4dd5-8480-83a985db4609 (view SPL)MORPHINESULFATEprescriptionHuman PrescriptionHospira, Inc.2012-06-062004092028, 004092029, 004096028
76023606c-150c-40c5-9175-598efe2a56c3 (view SPL)These highlights do not include all the information needed to use morphine sulfate injection, USP safely and effectively. See full prescribing information for morphine sulfate injection, USP. MORPHINE sulfate injection, USP, preservative-free, solution for intravenous use, CII Initial U.S. Approval: 1984prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK2014-09-113006416125, 006416126, 006416127
86078699c-9461-4641-bd3e-dad62b6db648 (view SPL)Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, MedNetprescriptionHuman PrescriptionCantrell Drug Company2015-09-042525330160
974b2a815-7751-4c82-8fa7-9f29746940d5 (view SPL)Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride 30 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-08-176525330160
108e02a975-cfbf-453e-8552-d30f6291e794 (view SPL)Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNetprescriptionHuman PrescriptionCantrell Drug Company2015-08-173525330160
11911a6b35-cced-417d-91d1-a80db6596e6c (view SPL)Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride 100 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-09-033525330160
1295681101-8898-4c77-9ed3-c512647a1597 (view SPL)Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride 2 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2014-05-024525330160
13a2edd898-1688-436a-ac04-6859fdafa6b9 (view SPL)MorphineSulfate 1 mg/mL in 0.9% Sodium Chloride 30 mL Monoject Syringe Barrel.prescriptionHuman PrescriptionCantrell Drug Company2015-05-1812525330160
14ab4a4e86-bc2b-42d5-bc47-1a73f872217b (view SPL)Morphine Sulfate Injection, USPCIIRx onlyFOR SUBCUTANEOUS, INTRAMUSCULAR ORSLOW INTRAVENOUS ADMINISTRATIONNOT FOR EPIDURAL OR INTRATHECAL ADMINISTRATIONprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-07-212006416068, 006416071, 006416072, 006416073, 006416075, 006416070
15c6e2b3fd-691b-4f1f-94a4-ede191e0de78 (view SPL)Morphine SulfateprescriptionHuman PrescriptionAmphastar Pharmaceuticals, Inc.2010-09-231005481911, 005483391Morphine Prefilled Syringe
16cadc3fdb-8edc-44cd-aaea-89e68aaf9a04 (view SPL)MORPHINE SULFATEprescriptionHuman PrescriptionHospira, Inc.2012-09-041004091134, 004091135
17cc3600b4-4ac2-4d79-a381-58cebf4d2d3f (view SPL)Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride 50 mL SyringeprescriptionHuman PrescriptionCantrell Drug Company2015-08-176525330160
18d3f37738-336f-40e1-a7ee-81cb924b8cd7 (view SPL)Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride 60 mL BagprescriptionHuman PrescriptionCantrell Drug Company2015-05-195525330160
19d473ebeb-960b-4852-82f4-4981469b0f39 (view SPL)Morphine SulfateInjection, USPprescriptionHuman PrescriptionHospira, Inc.2012-08-301004096179, 004096177
20db9ac9e3-d761-4a99-9f34-4946ebe8f255 (view SPL)INFUMORPH 200INFUMORPH 500(Preservative-free Morphine Sulfate Sterile Solution)CIIFor Use in Continuous Microinfusion DevicesRx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-10-111006416039, 006416040
21e360d6b6-d9ef-487d-bf14-fcbbee8beb29 (view SPL)prescriptionHuman PrescriptionInternational Medication Systems, Limitedanalysis, label, manufacture2015-05-114763291911
22ebb18761-e5c4-4238-bb84-f9549f500210 (view SPL)PRESERVATIVE-FREE Duramorph (morphine sulfate injection, USP) CIIRx only Not For Use in Continuous Microinfusion DevicesprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2013-11-043006416019, 006416020
23ed9ada68-6104-4b33-866d-76ad768a2ec2 (view SPL)Morphine Sulfate 1 mg/mL in 5% Dextrose 100 mL BagprescriptionHuman PrescriptionCantrell Drug Company2014-10-202525330059

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