Hydrocodone Extended Release Oral Tablet

Brand(s)
Hysingla
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Purdue Pharma Lp (2015-02-28)
Oldest Current Product
2015-01-15
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\HYDROCODONE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\HYDROCODONE BITARTRATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\HYDROCODONE BITARTRATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\HYDROCODONE

product(s) by strength(s)

24 hr hydrocodone 100 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110276HysinglaNDAPurdue Pharma Lp2015-01-15HYDROCODONE BITARTRATEORALTABLET, EXTENDED RELEASENDA206627b7d23ac2-e776-9f62-3290-c64c2d6eb353

24 hr hydrocodone 120 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110277HysinglaNDAPurdue Pharma Lp2015-01-15HYDROCODONE BITARTRATEORALTABLET, EXTENDED RELEASENDA206627b7d23ac2-e776-9f62-3290-c64c2d6eb353

24 hr hydrocodone 20 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110271HysinglaNDAPurdue Pharma Lp2015-01-15HYDROCODONE BITARTRATEORALTABLET, EXTENDED RELEASENDA206627b7d23ac2-e776-9f62-3290-c64c2d6eb353

24 hr hydrocodone 30 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110272HysinglaNDAPurdue Pharma Lp2015-01-15HYDROCODONE BITARTRATEORALTABLET, EXTENDED RELEASENDA206627b7d23ac2-e776-9f62-3290-c64c2d6eb353

24 hr hydrocodone 40 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110273HysinglaNDAPurdue Pharma Lp2015-01-15HYDROCODONE BITARTRATEORALTABLET, EXTENDED RELEASENDA206627b7d23ac2-e776-9f62-3290-c64c2d6eb353

24 hr hydrocodone 60 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110274HysinglaNDAPurdue Pharma Lp2015-01-15HYDROCODONE BITARTRATEORALTABLET, EXTENDED RELEASENDA206627b7d23ac2-e776-9f62-3290-c64c2d6eb353

24 hr hydrocodone 80 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1590110275HysinglaNDAPurdue Pharma Lp2015-01-15HYDROCODONE BITARTRATEORALTABLET, EXTENDED RELEASENDA206627b7d23ac2-e776-9f62-3290-c64c2d6eb353

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA206627HYSINGLAPURDUE PHARMA LP2014-11-20p8647667, SUBSTANCE
p9023401, SUBSTANCE
p8551520, SUBSTANCE
p9084816, SUBSTANCE
p9095614, MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY
p9095615, SUBSTANCE
p8361499, SUBSTANCE
p8529948, SUBSTANCE
p6733783, MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, SUBSTANCE
p9056052, SUBSTANCE
p8309060, MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, SUBSTANCE
p6488963, SUBSTANCE
p9060940, MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY
p8808740, MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, SUBSTANCE
NDA206627_001, NDA206627_002, NDA206627_003, NDA206627_004, NDA206627_005, NDA206627_006, NDA206627_007

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206627_001RXHYDROCODONE BITARTRATE (20MG)ORALTABLET, EXTENDED RELEASETrue2014-11-20HYSINGLA
2NDA206627_002RXHYDROCODONE BITARTRATE (30MG)ORALTABLET, EXTENDED RELEASEFalse2014-11-20HYSINGLA
3NDA206627_003RXHYDROCODONE BITARTRATE (40MG)ORALTABLET, EXTENDED RELEASEFalse2014-11-20HYSINGLA
4NDA206627_004RXHYDROCODONE BITARTRATE (60MG)ORALTABLET, EXTENDED RELEASEFalse2014-11-20HYSINGLA
5NDA206627_005RXHYDROCODONE BITARTRATE (80MG)ORALTABLET, EXTENDED RELEASEFalse2014-11-20HYSINGLA
6NDA206627_006RXHYDROCODONE BITARTRATE (100MG)ORALTABLET, EXTENDED RELEASEFalse2014-11-20HYSINGLA
7NDA206627_007RXHYDROCODONE BITARTRATE (120MG)ORALTABLET, EXTENDED RELEASEFalse2014-11-20HYSINGLA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6488963 (view patent)2017-06-24NDA206627, NDA022272Oxycodone Extended Release Oral Tablet
2p6733783 (view patent)2021-10-30NDA206627
3p8309060 (view patent)2023-11-20NDA206627, NDA022272, NDA200533, NDA201655Oxymorphone Extended Release Oral Tablet
tapentadol Extended Release Oral Tablet
Oxycodone Extended Release Oral Tablet
4p8361499 (view patent)2021-10-30NDA206627
5p8529948 (view patent)2022-08-06NDA206627
6p8551520 (view patent)2021-10-30NDA206627
7p8647667 (view patent)2021-10-30NDA206627
8p8808740 (view patent)2031-12-21NDA206627
9p9023401 (view patent)2021-10-30NDA206627
10p9056052 (view patent)2021-10-30NDA206627
11p9060940 (view patent)2021-10-30NDA206627
12p9084816 (view patent)2027-08-24NDA206627
13p9095614 (view patent)2027-08-24NDA206627
14p9095615 (view patent)2027-08-24NDA206627

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b7d23ac2-e776-9f62-3290-c64c2d6eb353 (view SPL)These highlights do not include all the information needed to use HYSINGLA ER safely and effectively. See full prescribing information for HYSINGLA ER. HYSINGLA ER (hydrocodone bitartrate) extended-release tablets, for oral use, CIIInitial U.S. Approval: 1943prescriptionHuman PrescriptionPurdue Pharma LpMANUFACTURE2015-02-283590110271, 590110272, 590110273, 590110274, 590110275, 590110276, 590110277

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