FDA.reportPublic FDA data

Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet [Hysingla]

RxCUI
1595772
RxNorm name
Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet [Hysingla]
Display name
HYSINGLA XR (Oral Pill)
Full name
Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet [Hysingla]
Term type
SBD
Status
Active
Strength
120 mg
Dose form
Abuse-Deterrent 24 HR XR Tab
Route
Oral Pill
Updated
2026-10-15 14:51:16

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 bitartrate120 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 120 MG 24 HR Extended Release Oral Tablet1NAMES
RxNorm NameAbuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet [Hysingla]1NAMES
RxNorm SynonymHysingla ER 120 MG 24 HR Extended Release Oral Tablet1NAMES
TTYSBD1ATTRIBUTES
RxCUI15957721CODES
MMSL_CODEBD299771CODES

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
59011027760rxnav_ndcsyes

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b7d23ac2-e776-9f62-3290-c64c2d6eb353Hysingla ER 120 MG 24HR Extended Release Oral Tablet [PSN] · Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet [Hysingla] [SBD] · Hysingla ER 120 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_STRENGTH120 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUALITATIVE_DISTINCTIONAbuse-Deterrent
ATTRIBUTESQUANTITY24 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
NAMESPrescribable SynonymHysingla ER 120 MG 24HR Extended Release Oral Tablet
NAMESTallman SynonymAbuse-Deterrent 24 HR HYDROcodone bitartrate 120 MG Extended Release Oral Tablet [Hysingla]
SOURCESSourceGold Standard Alchemy
SOURCESSourceMultum MediSource Lexicon