FDA.reportPublic FDA data

Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet

RxCUI
1595730
RxNorm name
Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet
Display name
HYDROcodone XR (Oral Pill)
Full name
Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet
Term type
SCD
Status
Active
Strength
20 mg
Dose form
Abuse-Deterrent 24 HR XR Tab
Route
Oral Pill
Updated
2026-10-15 14:50:44

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
hydrocodone bitartrate20 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_STRAbuse-Deterrent 24 HR HYDROcodone bitartrate 20 MG Extended Release Oral Tablet1NAMES
RxNorm NameAbuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet1NAMES
RxNorm Synonymhydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_IDf7b55d14-0980-b680-8ceb-7489ff65455e1CODES
RxCUI15957301CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
47781-392-6047781-392Hydrocodone Bitartrate Hydrocodone BitartrateAlvogen Inc.ANDA208269

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20826947781-392Hydrocodone Bitartrate Hydrocodone BitartrateANDAAlvogen Inc.

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
47781039260rxnav_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 · 2 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
rxcui: 1595730
Hydrocodone BitartrateHYDROCODONE BITARTRATEAlvogen Inc.f7b55d14-0980-b680-8ceb-7489ff65455e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 47781-392-60
ndc (product): 47781-392
ndc11 (package): 47781039260
rxcui: 1595730

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
b7d23ac2-e776-9f62-3290-c64c2d6eb353HYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent [PSN] · Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet [SCD] · hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent [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
f7b55d14-0980-b680-8ceb-7489ff65455eHYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent [PSN] · Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet [SCD] · hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent [SY]38These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS. HYDROCODONE BITARTRATE extended-release tablets, for oral use, CII Initial U.S. Approval: 194320251007

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
f7b55d14-0980-b680-8ceb-7489ff65455eThese highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS. HYDROCODONE BITARTRATE extended-release tablets, for oral use, CII Initial U.S. Approval: 1943Alvogen Inc.20251007
f7b55d14-0980-b680-8ceb-7489ff65455eThese highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS. HYDROCODONE BITARTRATE extended-release tablets, for oral use, CII Initial U.S. Approval: 1943Alvogen Inc.20251007
f7b55d14-0980-b680-8ceb-7489ff65455eThese highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS. HYDROCODONE BITARTRATE extended-release tablets, for oral use, CII Initial U.S. Approval: 1943Alvogen Inc.20240101

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_STRENGTH20 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESQUALITATIVE_DISTINCTIONAbuse-Deterrent
ATTRIBUTESQUANTITY24 HR
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESANDAANDA208269
CODESVUID4033976
NAMESPrescribable SynonymHYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent
NAMESTallman SynonymAbuse-Deterrent 24 HR HYDROcodone bitartrate 20 MG Extended Release Oral Tablet
NAMESTallman SynonymHYDROcodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File