FDA.reportPublic FDA data

acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]

RxCUI
1190201
RxNorm name
acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
Display name
TREZIX (Oral Pill)
Full name
acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
Term type
SBD
Status
Active
Strength
320.5-30-16 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-07-20 06:51:48

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112011
Active start
112011
Multiple ingredient
YES
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen320.5 MG / 1 EACHacetaminophenacetaminophen
caffeine30 MG / 1 EACHcaffeinecaffeine
dihydrocodeine bitartrate16 MG / 1 EACHdihydrocodeinedihydrocodeine bitartrate

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
caffeine1886
dihydrocodeine23088

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRAPAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]1NAMES
RxNorm Nameacetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID45c3c2a1-6a89-471e-b6d4-5a4cd73b987a1CODES
RxCUI11902011CODES
MMSL_CODEBD300131CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63187-705-0063187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785
63187-705-3063187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785
63187-705-6063187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785
63187-705-7263187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785
63187-705-9063187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateProficient Rx LPANDA204785

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20478563187-705Trezix acetaminophen, caffeine, dihydrocodeine bitartrateANDAProficient Rx LP

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 11 matching rows.

NDC11, Source, Active table
NDC11SourceActive
63187070500rxnav_ndcsyes
63187070530rxnav_ndcsyes
63187070560rxnav_ndcsyes
63187070572rxnav_ndcsyes
63187070590rxnav_ndcsyes
63629563701rxnav_ndcsyes
63629563702rxnav_ndcsyes
63629563703rxnav_ndcsyes
63629563704rxnav_ndcsyes
66992084010rxnav_ndcsyes
66992034010rxnav_historical

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
TrezixACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEProficient Rx LP45c3c2a1-6a89-471e-b6d4-5a4cd73b987a2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 63187-705-60
ndc (package): 63187-705-00
ndc (package): 63187-705-90
ndc (package): 63187-705-72
ndc (package): 63187-705-30
ndc (product): 63187-705
ndc11 (package): 63187070572
ndc11 (package): 63187070500
ndc11 (package): 63187070530
ndc11 (package): 63187070590
ndc11 (package): 63187070560
rxcui: 1190201

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
a519a201-bcfd-4029-9bdf-fc3e03f975acTREZIX 16 MG / 320.5 MG / 30 MG Oral Capsule [PSN] · acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix] [SBD] · APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix] [SY] · Trezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral Capsule [SY]412TREZIX™ Capsules20210203
45c3c2a1-6a89-471e-b6d4-5a4cd73b987aTREZIX 16 MG / 320.5 MG / 30 MG Oral Capsule [PSN] · acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix] [SBD] · APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix] [SY] · Trezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral Capsule [SY]46TREZIX™ Capsules20220502

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
45c3c2a1-6a89-471e-b6d4-5a4cd73b987aTREZIX™ CapsulesProficient Rx LP20220502
f90f87cb-77ad-45f4-8b59-09459090d988TREZIX™ CapsulesBryant Ranch Prepack20211222
a519a201-bcfd-4029-9bdf-fc3e03f975acTREZIX™ CapsulesWraser Llc20210203
e39685de-c542-4cce-bf11-041c4d933061National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
ATCN02AANatural opium alkaloidsATC1-4dihydrocodeine
ATCD11AXOther dermatologicalsATC1-4caffeine
ATCN06BCXanthine derivativesATC1-4caffeine
FDASPLD014970XanthinesCHEMhas_chemical_structurecaffeine
FDASPLN0000175739Central Nervous System StimulantEPChas_epccaffeine
FDASPLN0000175790MethylxanthineEPChas_epccaffeine
FDASPLN0000175690Opioid AgonistEPChas_epcdihydrocodeine
FDASPLN0000175684Full Opioid AgonistsMOAhas_moadihydrocodeine
FDASPLN0000175729Central Nervous System StimulationPEhas_pecaffeine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD002110CaffeineCHEMhas_ingredientcaffeine
MEDRTD003061CodeineCHEMhas_ingredientdihydrocodeine
MEDRTD003061CodeineCHEMhas_ingredientdihydrocodeine bitartrate
MEDRTD001049ApneaDISEASEmay_treatcaffeine
MEDRTD001249AsthmaDISEASEci_withdihydrocodeine
MEDRTD001249AsthmaDISEASEci_withdihydrocodeine bitartrate
MEDRTD002648ChildDISEASEci_withdihydrocodeine
MEDRTD002648ChildDISEASEci_withdihydrocodeine bitartrate
MEDRTD003371CoughDISEASEmay_treatdihydrocodeine bitartrate
MEDRTD003371CoughDISEASEmay_treatdihydrocodeine
MEDRTD004342Drug HypersensitivityDISEASEci_withdihydrocodeine bitartrate
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withcaffeine
MEDRTD004342Drug HypersensitivityDISEASEci_withdihydrocodeine
MEDRTD005221FatigueDISEASEmay_treatcaffeine
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD007415Intestinal ObstructionDISEASEci_withdihydrocodeine bitartrate
MEDRTD007415Intestinal ObstructionDISEASEci_withdihydrocodeine
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_treatdihydrocodeine
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatdihydrocodeine bitartrate
MEDRTD011247PregnancyDISEASEci_withdihydrocodeine
MEDRTD011247PregnancyDISEASEci_withdihydrocodeine bitartrate
MEDRTD012131Respiratory InsufficiencyDISEASEci_withdihydrocodeine
MEDRTD012131Respiratory InsufficiencyDISEASEci_withdihydrocodeine bitartrate
MEDRTN0000000133Enzyme InhibitorsMOAhas_moacaffeine
MEDRTN0000175684Full Opioid AgonistsMOAhas_moadihydrocodeine
MEDRTN0000175684Full Opioid AgonistsMOAhas_moadihydrocodeine bitartrate
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175439AnalgesiaPEhas_pedihydrocodeine bitartrate
MEDRTN0000175439AnalgesiaPEhas_pedihydrocodeine
MEDRTN0000008322BronchodilationPEhas_pecaffeine
MEDRTN0000008331Cardiovascular Activity AlterationPEhas_pecaffeine
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000175728Central Nervous System DepressionPEci_pedihydrocodeine bitartrate
MEDRTN0000175728Central Nervous System DepressionPEci_pedihydrocodeine
MEDRTN0000008567Decreased Collecting Duct Water PermeabilityPEhas_pecaffeine
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pedihydrocodeine
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pedihydrocodeine bitartrate
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000009197Increased Central Nervous System Organized Electrical ActivityPEhas_pecaffeine
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH320.5 MG / 30 MG / 16 MG (expressed as dihydrocodeine bitartrate)
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE3
CODESANDAANDA204785
NAMESPrescribable SynonymTREZIX 16 MG / 320.5 MG / 30 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon