Naltrexone Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sun Pharma Global Fze (2015-05-06)
Oldest Current Product
1998-05-08
License(s)
ANDA
RxNORM
ORAL TABLET\NALTREXONE
FDAOB
ORAL\TABLET\NALTREXONE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\NALTREXONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\NALTREXONE

product(s) by strength(s)

naltrexone hydrochloride 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004061170ANDAMallinckrodt, Inc.2009-07-29NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA07626406ff2d5a-e62b-4fa4-bbdb-01938535bc65
2005550902ANDABarr Laboratories Inc.1998-05-08NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0749184a63f1e0-b2a3-4355-af61-852ea3521707
3167290081ANDAAccord Healthcare Inc.2011-10-01NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA09120549aa3d6d-2270-4615-aafa-b440859ab870
4473350326ANDASun Pharma Global Fze2012-02-29NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0903560f30f885-d0cd-4fa6-a8e0-142f08a56792
5512240206ANDATagi Pharma, Inc.2013-09-23NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATEDANDA07527460276f5c-657a-4b60-bcd0-44234903d7e0

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910632ANDAAvkare, Inc.2015-03-26NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED512240206ANDA07527421b43dab-015c-c82f-ba6e-27da0ec12fc5
2430630469ANDAPd-Rx Pharmaceuticals, Inc.1998-05-08NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED005550902ANDA0749188bce9770-4b91-447b-8581-a2aafcf2fde6
3430630591ANDAPd-Rx Pharmaceuticals, Inc.2009-07-29NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED004061170ANDA07626415109f04-6738-4d7c-a5fa-38416d4584f6
4504360105ANDAUnit Dose Services1998-05-08NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED005550902ANDA07491846623a72-461c-4728-b78e-d9bb98d83582
5521250727ANDARemedyrepack Inc.2013-10-07NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED167290081ANDA091205242116b0-b874-40cb-911b-49462cf6a245
6548685574ANDAPhysicians Total Care, Inc.2006-04-19NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED005550902ANDA0749183c7da2bc-e2c1-48f6-8c3f-287119b427e2
7636295304ANDABryant Ranch Prepack1998-05-08NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED005550902ANDA074918ca7b968e-c2e5-4c04-af36-acf04e8b8f77
8680840291ANDAAmerican Health Packaging2012-01-02NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED004061170ANDA07626481e25c6a-81b6-4cfb-91bf-be20c3ae546b
9680940853ANDAPrecision Dose Inc.2014-10-29NALTREXONE HYDROCHLORIDEORALTABLET, FILM COATED512240206ANDA07527474087d2f-468d-4de1-a2fc-a489d0f2abef

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074918NALTREXONE HYDROCHLORIDEBARR LABORATORIES INC1998-05-08ANDA074918_001
2ANDA075274NALTREXONE HYDROCHLORIDEELITE LABORATORIES INC1999-05-26ANDA075274_001
3ANDA075434NALTREXONE HYDROCHLORIDETrueSANDOZ INC2000-03-08ANDA075434_001
4ANDA076264NALTREXONE HYDROCHLORIDEMALLINCKRODT INC2002-03-22ANDA076264_001, ANDA076264_002, ANDA076264_003
5ANDA090356NALTREXONE HYDROCHLORIDESUN PHARMA GLOBAL FZE2012-02-24ANDA090356_001
6ANDA091205NALTREXONE HYDROCHLORIDEACCORD HEALTHCARE INC2011-08-17ANDA091205_001
7NDA018932REVIATEVA WOMENS HEALTH INC1984-11-20NDA018932_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074918_001RXNALTREXONE HYDROCHLORIDE (50MG)ORALTABLETFalseAB1998-05-08NALTREXONE HYDROCHLORIDE
2ANDA075274_001RXNALTREXONE HYDROCHLORIDE (50MG)ORALTABLETFalseAB1999-05-26NALTREXONE HYDROCHLORIDE
3ANDA075434_001discontinuedNALTREXONE HYDROCHLORIDE (50MG)ORALTABLETFalse2000-03-08NALTREXONE HYDROCHLORIDE
4ANDA076264_001RXNALTREXONE HYDROCHLORIDE (25MG)ORALTABLETFalse2002-03-22NALTREXONE HYDROCHLORIDE
5ANDA076264_002RXNALTREXONE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2002-03-22NALTREXONE HYDROCHLORIDE
6ANDA076264_003RXNALTREXONE HYDROCHLORIDE (100MG)ORALTABLETFalse2002-03-22NALTREXONE HYDROCHLORIDE
7ANDA090356_001RXNALTREXONE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2012-02-24NALTREXONE HYDROCHLORIDE
8ANDA091205_001RXNALTREXONE HYDROCHLORIDE (50MG)ORALTABLETFalseAB2011-08-17NALTREXONE HYDROCHLORIDE
9NDA018932_001RXNALTREXONE HYDROCHLORIDE (50MG)ORALTABLETTrueAB1984-11-20REVIA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
106ff2d5a-e62b-4fa4-bbdb-01938535bc65 (view SPL)NALTREXONE HYDROCHLORIDE TABLETS USP50 mg Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, MANUFACTURE2014-11-307004061170
20f30f885-d0cd-4fa6-a8e0-142f08a56792 (view SPL)Naltrexone Hydrochloride Tablets, USPOpioid AntagonistprescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-05-065473350326
315109f04-6738-4d7c-a5fa-38416d4584f6 (view SPL)NALTREXONE HYDROCHLORIDE TABLETS USP50 mg Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-11-308430630591
421b43dab-015c-c82f-ba6e-27da0ec12fc5 (view SPL)Naltrexone Hydrochloride Tablets USP, film coatedprescriptionHuman PrescriptionAvkare, Inc.2015-03-261422910632
5242116b0-b874-40cb-911b-49462cf6a245 (view SPL)Naltrexone Hydrochloride Tablets USP 50 mg Opiod AntagonistprescriptionHuman PrescriptionRemedyrepack Inc.2013-10-071521250727
63c7da2bc-e2c1-48f6-8c3f-287119b427e2 (view SPL)NALTREXONE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-05-011548685574
746623a72-461c-4728-b78e-d9bb98d83582 (view SPL)NALTREXONE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-08-222504360105
849aa3d6d-2270-4615-aafa-b440859ab870 (view SPL)Naltrexone Hydrochloride Tablets USP 50 mgprescriptionHuman PrescriptionAccord Healthcare Inc.analysis, manufacture2014-10-112167290081
94a63f1e0-b2a3-4355-af61-852ea3521707 (view SPL)NALTREXONE HYDROCHLORIDE TABLETS USP50 mg Opioid AntagonistprescriptionHuman PrescriptionBarr Laboratories Inc.2013-12-175005550902
1060276f5c-657a-4b60-bcd0-44234903d7e0 (view SPL)Naltrexone Hydrochloride Tablets USP, film coatedprescriptionHuman PrescriptionTagi Pharma, Inc.2014-02-251512240206
1174087d2f-468d-4de1-a2fc-a489d0f2abef (view SPL)Naltrexone Hydrochloride Tablets USP, film coatedprescriptionHuman PrescriptionPrecision Dose Inc.2014-11-061680940853
1281e25c6a-81b6-4cfb-91bf-be20c3ae546b (view SPL)Naltrexone Hydrochloride Tablets USP8229121/0715Rx OnlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-113680840291
138bce9770-4b91-447b-8581-a2aafcf2fde6 (view SPL)NALTREXONE HYDROCHLORIDE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-08-224430630469
14ca7b968e-c2e5-4c04-af36-acf04e8b8f77 (view SPL)NALTREXONE HYDROCHLORIDE TABLETS USP50 mg Opioid AntagonistprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-03-261001636295304

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