FDA.reportPublic FDA data

Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet [Hysingla]

RxCUI
1595754
RxNorm name
Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet [Hysingla]
Display name
HYSINGLA XR (Oral Pill)
Full name
Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet [Hysingla]
Term type
SBD
Status
Active
Strength
60 mg
Dose form
Abuse-Deterrent 24 HR XR Tab
Route
Oral Pill
Updated
2026-10-15 14:51:03

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012015
Active start
012015
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
hydrocodone bitartrate60 MG / 1 EACHhydrocodonehydrocodone bitartrate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Extended Release Oral Tablet316945

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
hydrocodone5489

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRHysingla ER 60 MG 24 HR Extended Release Oral Tablet1NAMES
RxNorm NameAbuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet [Hysingla]1NAMES
RxNorm SynonymHysingla ER 60 MG 24 HR Extended Release Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDb7d23ac2-e776-9f62-3290-c64c2d6eb3531CODES
RxCUI15957541CODES
MMSL_CODEBD299741CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
59011-274-6059011-274Hysingla ER hydrocodone bitartrateKnoa Pharma LLCNDA206627

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA20662759011-274Hysingla ER hydrocodone bitartrateNDAKnoa Pharma LLC

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
59011027460rxnav_ndcsyes

UNII Substances#

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

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hysingla ERHYDROCODONE BITARTRATEKnoa Pharma LLCb7d23ac2-e776-9f62-3290-c64c2d6eb3532026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 59011-274-60
ndc (product): 59011-274
ndc11 (package): 59011027460
rxcui: 1595754

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b7d23ac2-e776-9f62-3290-c64c2d6eb353Hysingla ER 60 MG 24HR Extended Release Oral Tablet [PSN] · Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet [Hysingla] [SBD] · Hysingla ER 60 MG 24 HR Extended Release Oral Tablet [SY]316These 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, CII Initial U.S. Approval: 194320260501

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
b7d23ac2-e776-9f62-3290-c64c2d6eb353These 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, CII Initial U.S. Approval: 1943Knoa Pharma LLC | Knoa Pharmaceuticals LLC.20260529
b7d23ac2-e776-9f62-3290-c64c2d6eb353These 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, CII Initial U.S. Approval: 1943Knoa Pharma LLC | Knoa Pharmaceuticals L.P.20260501
b7d23ac2-e776-9f62-3290-c64c2d6eb353These 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, CII Initial U.S. Approval: 1943Knoa Pharma LLC | Knoa Pharmaceuticals L.P.20260420
b7d23ac2-e776-9f62-3290-c64c2d6eb353These 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, CII Initial U.S. Approval: 1943Purdue Pharma LP | Purdue Pharmaceuticals L.P.20260113

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_STRENGTH60 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUALITATIVE_DISTINCTIONAbuse-Deterrent
ATTRIBUTESQUANTITY24 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESNDANDA206627
NAMESPrescribable SynonymHysingla ER 60 MG 24HR Extended Release Oral Tablet
NAMESTallman SynonymAbuse-Deterrent 24 HR HYDROcodone bitartrate 60 MG Extended Release Oral Tablet [Hysingla]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon