FDA.reportPublic FDA data

Zohydro

Product NDC
43376-340
11-digit product format
433760340
Labeler code
43376
Product ID
43376-340_5acca313-4e09-4063-83f3-49ffc4d6fe76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrocodone bitartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zogenix, Inc.
Application
NDA202880
Marketing category
NDA
Marketing start
2013-10-25
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE
Active strength
40 mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43376-340-602020-01-31C16284748780-19d75b9cf-f080-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ZOHYDRO ® ER safely and effectively. See full prescribing information for ZOHYDRO ® ER. ZOHYDRO ® ER (hydrocodone bitartrate) extended‑release capsules, for oral use, CII Initial U.S. Approval: 1943

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43376-340-60Zohydro60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43376-340-60EA - Each43376-34031f8d1b1-ef4e-49d7-aa63-c069958967b612015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
GELATININACTIVE INGREDIENT2G86QN327LZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
POVIDONESINACTIVE INGREDIENTFZ989GH94EZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
SUCROSEINACTIVE INGREDIENTC151H8M554ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
TALCINACTIVE INGREDIENT7SEV7J4R1UZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43376-340ZOHYDRO (HYDROCODONE BITARTRATE) CAPSULE, EXTENDED RELEASE [ZOGENIX, INC.]20Legacy NDC, 1 package rows20150227_6ccfbd98-7750-4955-a654-ec104fb666f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860491HYDROcodone bitartrate 10 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860493HYDROcodone bitartrate 15 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860495HYDROcodone bitartrate 20 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860497HYDROcodone bitartrate 30 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860499HYDROcodone bitartrate 40 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860501HYDROcodone bitartrate 50 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860492Zohydro ER 10 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860494Zohydro ER 15 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860496Zohydro ER 20 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860498Zohydro ER 30 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860500Zohydro ER 40 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
1860502Zohydro ER 50 MG 12HR Extended Release Oral CapsulePSN6ccfbd98-7750-4955-a654-ec104fb666f920
186049212 HR hydrocodone bitartrate 10 MG Extended Release Oral Capsule [Zohydro]SBD6ccfbd98-7750-4955-a654-ec104fb666f920
186049412 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro]SBD6ccfbd98-7750-4955-a654-ec104fb666f920
186049612 HR hydrocodone bitartrate 20 MG Extended Release Oral Capsule [Zohydro]SBD6ccfbd98-7750-4955-a654-ec104fb666f920
186049812 HR hydrocodone bitartrate 30 MG Extended Release Oral Capsule [Zohydro]SBD6ccfbd98-7750-4955-a654-ec104fb666f920
186050012 HR hydrocodone bitartrate 40 MG Extended Release Oral Capsule [Zohydro]SBD6ccfbd98-7750-4955-a654-ec104fb666f920
186050212 HR hydrocodone bitartrate 50 MG Extended Release Oral Capsule [Zohydro]SBD6ccfbd98-7750-4955-a654-ec104fb666f920
186049112 HR hydrocodone bitartrate 10 MG Extended Release Oral CapsuleSCD6ccfbd98-7750-4955-a654-ec104fb666f920
186049312 HR hydrocodone bitartrate 15 MG Extended Release Oral CapsuleSCD6ccfbd98-7750-4955-a654-ec104fb666f920
186049512 HR hydrocodone bitartrate 20 MG Extended Release Oral CapsuleSCD6ccfbd98-7750-4955-a654-ec104fb666f920
186049712 HR hydrocodone bitartrate 30 MG Extended Release Oral CapsuleSCD6ccfbd98-7750-4955-a654-ec104fb666f920
186049912 HR hydrocodone bitartrate 40 MG Extended Release Oral CapsuleSCD6ccfbd98-7750-4955-a654-ec104fb666f920
186050112 HR hydrocodone bitartrate 50 MG Extended Release Oral CapsuleSCD6ccfbd98-7750-4955-a654-ec104fb666f920
186049212 HR Zohydro 10 MG Extended Release Oral CapsuleSY6ccfbd98-7750-4955-a654-ec104fb666f920
186049412 HR Zohydro 15 MG Extended Release Oral CapsuleSY6ccfbd98-7750-4955-a654-ec104fb666f920
186049612 HR Zohydro 20 MG Extended Release Oral CapsuleSY6ccfbd98-7750-4955-a654-ec104fb666f920
186049812 HR Zohydro 30 MG Extended Release Oral CapsuleSY6ccfbd98-7750-4955-a654-ec104fb666f920
186050012 HR Zohydro 40 MG Extended Release Oral CapsuleSY6ccfbd98-7750-4955-a654-ec104fb666f920
186050212 HR Zohydro 50 MG Extended Release Oral CapsuleSY6ccfbd98-7750-4955-a654-ec104fb666f920

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43376-340-604337603406060 in 1 BOTTLEHistorical