Ibuprofen Injectable Solution

Brand(s)
Caldolor, Neoprofen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Cumberland Pharmaceuticals Inc. (2014-03-28)
Oldest Current Product
2006-04-13
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\IBUPROFEN
FDAOB
INTRAVENOUS\INJECTION\IBUPROFEN LYSINE
INTRAVENOUS\SOLUTION\IBUPROFEN
SPL Active
INTRAVENOUS\INJECTION\IBUPROFEN
INTRAVENOUS\SOLUTION\IBUPROFEN LYSINE
SPL Moiety
INTRAVENOUS\INJECTION\IBUPROFEN
INTRAVENOUS\SOLUTION\IBUPROFEN

product(s) by strength(s)

ibuprofen 10 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1552920122NeoprofenNDARecordati Rare Diseases, Inc.2006-04-13IBUPROFEN LYSINEINTRAVENOUSSOLUTIONNDA0219036f5ede6f-b0b7-4fc8-969e-652f60ead047

ibuprofen 100 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1662200287CaldolorNDACumberland Pharmaceuticals Inc.2009-06-11IBUPROFENINTRAVENOUSINJECTIONNDA0223481eaa7790-f1a1-4f51-b10a-cbbaf033f684

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021903NEOPROFENRECORDATI RARE DISEASES INC2006-04-13p6344479, CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G, SUBSTANCE
p6342530, CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS WEIGHING BETWEEN 500 AND 1500G/ TREATMENT OF PATENT DUCTUS ARTERIOSUS, SUBSTANCE
p8415337, SUBSTANCE
NDA021903_001
2NDA022348CALDOLORCUMBERLAND PHARMACEUTICALS INC2009-06-11p6727286, MANAGEMENT OF MILD TO MODERATE PAIN, SUBSTANCE
p8735452, MANAGEMENT OF MILD TO MODERATE PAIN
p8871810, MANAGEMENT OF MILD TO MODERATE PAIN
p9114068, METHODS OF TREATING PAIN
p9138404, METHODS OF TREATING PAIN
p9012508, MANAGEMENT OF MILD TO MODERATE PAIN
NDA022348_001, NDA022348_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021903_001RXIBUPROFEN LYSINE (EQ 20MG BASE/2ML)INTRAVENOUSINJECTIONTrue2006-04-13NEOPROFEN
2NDA022348_001discontinuedIBUPROFEN (400MG/4ML)INTRAVENOUSSOLUTIONFalse2009-06-11CALDOLOR
3NDA022348_002RXIBUPROFEN (800MG/8ML)INTRAVENOUSSOLUTIONTrue2009-06-11CALDOLOR

patent(s)

#idexpiration dateapplication(s)
1p6342530 (view patent)2020-11-14NDA021903
2p6344479 (view patent)2021-03-20NDA021903
3p6727286 (view patent)2021-11-27NDA022348
4p8415337 (view patent)2032-03-02NDA021903
5p8735452 (view patent)2029-09-30NDA022348
6p8871810 (view patent)2029-09-30NDA022348
7p9012508 (view patent)2030-09-14NDA022348
8p9114068 (view patent)2029-09-30NDA022348
9p9138404 (view patent)2029-09-30NDA022348

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11eaa7790-f1a1-4f51-b10a-cbbaf033f684 (view SPL)These highlights do not include all the information needed to use Caldolor safely and effectively. See full prescribing information for Caldolor. CALDOLOR (ibuprofen) Injection, for intravenous useInitial U.S. Approval: 1974prescriptionHuman PrescriptionCumberland Pharmaceuticals Inc.2014-03-282662200287, 662200247
26f5ede6f-b0b7-4fc8-969e-652f60ead047 (view SPL)These highlights do not include all the information needed to use NeoProfen safely and effectively. See full prescribing information for NeoProfen. NeoProfen (ibuprofen lysine)Injection for intravenous use Initial U.S. Approval: 2006prescriptionHuman PrescriptionRecordati Rare Diseases, Inc.MANUFACTURE2013-12-174552920122

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