Hydrocodone Extended Release Oral Capsule

Brand(s)
Zohydro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Zogenix, Inc. (2015-02-25)
Oldest Current Product
2013-10-25
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\HYDROCODONE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\HYDROCODONE BITARTRATE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\HYDROCODONE BITARTRATE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\HYDROCODONE

product(s) by strength(s)

hydrocodone bitartrate 10 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1433760310ZohydroNDAZogenix, Inc.2013-10-25HYDROCODONE BITARTRATEORALCAPSULE, EXTENDED RELEASENDA2028806ccfbd98-7750-4955-a654-ec104fb666f9

hydrocodone bitartrate 15 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1433760315ZohydroNDAZogenix, Inc.2013-10-25HYDROCODONE BITARTRATEORALCAPSULE, EXTENDED RELEASENDA2028806ccfbd98-7750-4955-a654-ec104fb666f9

hydrocodone bitartrate 20 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1433760220ZohydroNDAZogenix, Inc.2013-10-25HYDROCODONE BITARTRATEORALCAPSULE, EXTENDED RELEASENDA202880cf68f7fe-30a9-4f1a-a3a4-6352dc436bbe

hydrocodone bitartrate 30 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1433760230ZohydroNDAZogenix, Inc.2013-10-25HYDROCODONE BITARTRATEORALCAPSULE, EXTENDED RELEASENDA202880cf68f7fe-30a9-4f1a-a3a4-6352dc436bbe

hydrocodone bitartrate 40 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1433760340ZohydroNDAZogenix, Inc.2013-10-25HYDROCODONE BITARTRATEORALCAPSULE, EXTENDED RELEASENDA2028806ccfbd98-7750-4955-a654-ec104fb666f9

hydrocodone bitartrate 50 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1433760350ZohydroNDAZogenix, Inc.2013-10-25HYDROCODONE BITARTRATEORALCAPSULE, EXTENDED RELEASENDA2028806ccfbd98-7750-4955-a654-ec104fb666f9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202880ZOHYDRO ERPERNIX IRELAND PAIN LIMITED2013-10-25p6902742, SUBSTANCE
p6228398, SUBSTANCE
p9132096, SUBSTANCE
NEW PRODUCT [2016-10-25]NDA202880_001, NDA202880_002, NDA202880_003, NDA202880_004, NDA202880_005, NDA202880_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202880_001RXHYDROCODONE BITARTRATE (10MG)ORALCAPSULE, EXTENDED RELEASETrue2013-10-25ZOHYDRO ER
2NDA202880_002RXHYDROCODONE BITARTRATE (15MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-10-25ZOHYDRO ER
3NDA202880_003RXHYDROCODONE BITARTRATE (20MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-10-25ZOHYDRO ER
4NDA202880_004RXHYDROCODONE BITARTRATE (30MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-10-25ZOHYDRO ER
5NDA202880_005RXHYDROCODONE BITARTRATE (40MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-10-25ZOHYDRO ER
6NDA202880_006RXHYDROCODONE BITARTRATE (50MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-10-25ZOHYDRO ER

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6228398 (view patent)2019-11-01NDA202880, NDA021284, NDA021802dexmethylphenidate Extended Release Oral Capsule
Methylphenidate Extended Release Oral Capsule
2p6902742 (view patent)2019-11-01NDA202880
3p9132096 (view patent)2034-09-12NDA202880

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16ccfbd98-7750-4955-a654-ec104fb666f9 (view SPL)These highlights do not include all the information needed to useZOHYDRO ER safely and effectively. See full prescribing information for ZOHYDRO ER. ZOHYDRO ER (hydrocodone bitartrate) extendedrelease capsules, for oral use, CII Initial U.S. Approval: 1943prescriptionHuman PrescriptionZogenix, Inc.MANUFACTURE2015-02-2520433760310, 433760315, 433760340, 433760350, 433760320, 433760330
2cf68f7fe-30a9-4f1a-a3a4-6352dc436bbe (view SPL)These highlights do not include all the information needed to useZOHYDRO ER safely and effectively. See full prescribing information for ZOHYDRO ER. ZOHYDRO ER (hydrocodone bitartrate) extendedrelease capsules, for oral use, CII Initial U.S. Approval: 1943prescriptionHuman PrescriptionZogenix, Inc.MANUFACTURE2014-08-2613433760220, 433760230, 433760210, 433760215, 433760240, 433760250

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