FDA.reportPublic FDA data

acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Endocet]

RxCUI
1049227
RxNorm name
acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Endocet]
Display name
ENDOCET (Oral Pill)
Full name
acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Endocet]
Term type
SBD
Status
Active
Strength
325-7.5 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-17 23:43:51

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012011
Active start
012011
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
oxycodone hydrochloride7.5 MG / 1 EACHoxycodoneoxycodone hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
oxycodone7804

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STREndocet 7.5/325 Oral Tablet1NAMES
RxNorm Nameacetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Endocet]1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI10492271CODES
MMSL_CODEBD84851CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
60951-700-7060951-700ENDOCET Oxycodone and AcetaminophenPar Health USA, LLCANDA040330
63629-2190-163629-2190ENDOCET Oxycodone and AcetaminophenBryant Ranch PrepackANDA040330

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA04033060951-700ENDOCET Oxycodone and AcetaminophenANDAPar Health USA, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 21 matching rows.

NDC11, Source, Active table
NDC11SourceActive
60951070070rxnav_ndcsyes
63629219001rxnav_ndcsyes
68071028660rxnav_ndcsyes
68071028690rxnav_ndcsyes
00043032410rxnav_historical
00043032450rxnav_historical
10544038308rxnav_historical
10544038328rxnav_historical
10544038330rxnav_historical
10544038360rxnav_historical
10544038384rxnav_historical
23490782703rxnav_historical
23490782706rxnav_historical
23490782709rxnav_historical
42549058308rxnav_historical
42549058328rxnav_historical
42549058330rxnav_historical
42549058360rxnav_historical
42549058384rxnav_historical
60951070075rxnav_historical_indirect
60951070085rxnav_historical_indirect

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
ENDOCETOXYCODONE AND ACETAMINOPHENPar Health USA, LLC944d3e60-7eee-11de-a413-0002a5d5c51b2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 60951-700-70
ndc (product): 60951-700
ndc11 (package): 60951070070
rxcui: 1049227
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c32024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63629-2190-1
ndc (product): 63629-2190
ndc11 (package): 63629219001
rxcui: 1049227

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
3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3ENDOCET 7.5 MG / 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Endocet] [SBD] · APAP 325 MG / Oxycodone Hydrochloride 7.5 MG Oral Tablet [Endocet] [SY] · Endocet 7.5/325 (oxycodone HCl / APAP) Oral Tablet [SY] · Endocet 7.5/325 Oral Tablet [SY]5103ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 202420240808
944d3e60-7eee-11de-a413-0002a5d5c51bENDOCET 7.5 MG / 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Endocet] [SBD] · APAP 325 MG / Oxycodone Hydrochloride 7.5 MG Oral Tablet [Endocet] [SY] · Endocet 7.5/325 (oxycodone HCl / APAP) Oral Tablet [SY] · Endocet 7.5/325 Oral Tablet [SY]555ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: December 202520251201

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
944d3e60-7eee-11de-a413-0002a5d5c51bENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: December 2025Par Health USA, LLC20251201
3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c3ENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 2024Bryant Ranch Prepack20240808
944d3e60-7eee-11de-a413-0002a5d5c51bENDOCET ® Oxycodone and Acetaminophen Tablets, USP CII Rx only Revised: June 2024Par Health USA, LLC20240625
13bd9791-dd14-4c2e-b022-274eabac7fbcNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCN02AANatural opium alkaloidsATC1-4oxycodone
FDASPLN0000175690Opioid AgonistEPChas_epcoxycodone
FDASPLN0000175684Full Opioid AgonistsMOAhas_moaoxycodone
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD010098OxycodoneCHEMhas_ingredientoxycodone
MEDRTD010098OxycodoneCHEMhas_ingredientoxycodone hydrochloride
MEDRTD001249AsthmaDISEASEci_withoxycodone hydrochloride
MEDRTD001249AsthmaDISEASEci_withoxycodone
MEDRTD004342Drug HypersensitivityDISEASEci_withoxycodone hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withoxycodone
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD007415Intestinal ObstructionDISEASEci_withoxycodone hydrochloride
MEDRTD007415Intestinal ObstructionDISEASEci_withoxycodone
MEDRTD007418Intestinal Pseudo-ObstructionDISEASEci_withoxycodone
MEDRTD007418Intestinal Pseudo-ObstructionDISEASEci_withoxycodone hydrochloride
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010149Postoperative PainDISEASEmay_treatoxycodone hydrochloride
MEDRTD010149Postoperative PainDISEASEmay_treatoxycodone
MEDRTD011247PregnancyDISEASEci_withoxycodone
MEDRTD011247PregnancyDISEASEci_withoxycodone hydrochloride
MEDRTD012131Respiratory InsufficiencyDISEASEci_withoxycodone hydrochloride
MEDRTD012131Respiratory InsufficiencyDISEASEci_withoxycodone
MEDRTN0000175684Full Opioid AgonistsMOAhas_moaoxycodone hydrochloride
MEDRTN0000175684Full Opioid AgonistsMOAhas_moaoxycodone
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175439AnalgesiaPEhas_peoxycodone hydrochloride
MEDRTN0000175439AnalgesiaPEhas_peoxycodone
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008635Decreased GI MotilityPEhas_peoxycodone
MEDRTN0000008635Decreased GI MotilityPEhas_peoxycodone hydrochloride
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_peoxycodone
MEDRTN0000008701Decreased Medullary Respiratory DrivePEhas_peoxycodone hydrochloride
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_peoxycodone
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_peoxycodone hydrochloride
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000009353Increased Histamine ProductionPEhas_peoxycodone hydrochloride
MEDRTN0000009353Increased Histamine ProductionPEhas_peoxycodone
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH325 MG / 7.5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE2
CODESANDAANDA040330
NAMESPrescribable SynonymENDOCET 7.5 MG / 325 MG Oral Tablet
NAMESTallman Synonymacetaminophen 325 MG / oxyCODONE hydrochloride 7.5 MG Oral Tablet [Endocet]
NAMESTallman SynonymAPAP 325 MG / oxyCODONE Hydrochloride 7.5 MG Oral Tablet [Endocet]
NAMESTallman SynonymEndocet 7.5/325 (oxyCODONE HCl / APAP) Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon