FDA.reportPublic FDA data

12 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro]

RxCUI
1860494
RxNorm name
12 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro]
Display name
ZOHYDRO XR (Oral Pill)
Full name
12 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro]
Term type
SBD
Status
Active
Strength
15 mg
Dose form
12 HR XR Cap
Route
Oral Pill
Updated
2026-10-26 03:55:20

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012017
Active start
012017
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
hydrocodone bitartrate15 MG / 1 EACHhydrocodonehydrocodone bitartrate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Oral Capsule316943

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
hydrocodone5489

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STR12 HR Zohydro 15 MG Extended Release Oral Capsule1NAMES
RxNorm Name12 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro]1NAMES
RxNorm Synonym12 HR Zohydro 15 MG Extended Release Oral Capsule1NAMES
TTYSBD1ATTRIBUTES
RxCUI18604941CODES
MMSL_CODEBD291821CODES

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
65224031560rxnav_ndcsyes
43376021510rxnav_historical
43376031560rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6ccfbd98-7750-4955-a654-ec104fb666f9Zohydro ER 15 MG 12HR Extended Release Oral Capsule [PSN] · 12 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro] [SBD] · 12 HR Zohydro 15 MG Extended Release Oral Capsule [SY]320These 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: 194320150225
cf68f7fe-30a9-4f1a-a3a4-6352dc436bbeZohydro ER 15 MG 12HR Extended Release Oral Capsule [PSN] · 12 HR hydrocodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro] [SBD] · 12 HR Zohydro 15 MG Extended Release Oral Capsule [SY]313These 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: 194320140826

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
1b89a045-d552-40b6-a717-09858b5e6239These 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: 1943Persion Pharmaceuticals LLC | Recro Gainesville LLC20210309
6ccfbd98-7750-4955-a654-ec104fb666f9These 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: 1943Zogenix, Inc. | Alkermes Gainesville, LLC.20150225
cf68f7fe-30a9-4f1a-a3a4-6352dc436bbeThese 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: 1943Zogenix, Inc. | Alkermes Gainesville, LLC.20140826

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR05DAOpium alkaloids and derivativesATC1-4hydrocodone
FDASPLN0000175690Opioid AgonistEPChas_epchydrocodone
FDASPLN0000000174Opioid AgonistsMOAhas_moahydrocodone
MEDRTD006853HydrocodoneCHEMhas_ingredienthydrocodone bitartrate
MEDRTD006853HydrocodoneCHEMhas_ingredienthydrocodone
MEDRTD001249AsthmaDISEASEci_withhydrocodone bitartrate
MEDRTD001249AsthmaDISEASEci_withhydrocodone
MEDRTD003371CoughDISEASEmay_treathydrocodone
MEDRTD003371CoughDISEASEmay_treathydrocodone bitartrate
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocodone bitartrate
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocodone
MEDRTD007415Intestinal ObstructionDISEASEci_withhydrocodone bitartrate
MEDRTD007415Intestinal ObstructionDISEASEci_withhydrocodone
MEDRTD008173Lung Diseases, ObstructiveDISEASEmay_treathydrocodone
MEDRTD008173Lung Diseases, ObstructiveDISEASEmay_treathydrocodone bitartrate
MEDRTD010149Postoperative PainDISEASEmay_treathydrocodone bitartrate
MEDRTD010149Postoperative PainDISEASEmay_treathydrocodone
MEDRTD012131Respiratory InsufficiencyDISEASEci_withhydrocodone bitartrate
MEDRTD012131Respiratory InsufficiencyDISEASEci_withhydrocodone
MEDRTN0000191866Opioid mu-Receptor AgonistsMOAhas_moahydrocodone bitartrate
MEDRTN0000191866Opioid mu-Receptor AgonistsMOAhas_moahydrocodone
MEDRTN0000175439AnalgesiaPEhas_pehydrocodone bitartrate
MEDRTN0000175439AnalgesiaPEhas_pehydrocodone
MEDRTN0000008501Decreased Central Nervous System Organized Electrical ActivityPEci_pehydrocodone bitartrate
MEDRTN0000008501Decreased Central Nervous System Organized Electrical ActivityPEci_pehydrocodone
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pehydrocodone
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_pehydrocodone bitartrate
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pehydrocodone
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pehydrocodone bitartrate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH15 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUANTITY12 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
NAMESPrescribable SynonymZohydro ER 15 MG 12HR Extended Release Oral Capsule
NAMESTallman Synonym12 HR HYDROcodone bitartrate 15 MG Extended Release Oral Capsule [Zohydro]
SOURCESSourceGold Standard Alchemy