FDA.reportPublic FDA data

acetaminophen 325 MG / butalbital 25 MG Oral Tablet

RxCUI
1724446
RxNorm name
acetaminophen 325 MG / butalbital 25 MG Oral Tablet
Display name
Acetaminophen/Butalbital (Oral Pill)
Full name
acetaminophen 325 MG / butalbital 25 MG Oral Tablet
Term type
SCD
Status
Active
Strength
325-25 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-21 00:30:27

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012016
Active start
012016
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
butalbital25 MG / 1 EACHbutalbitalbutalbital

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
butalbital19860

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRacetaminophen 325 MG / butalbital 25 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 325 MG / butalbital 25 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 325 MG / butalbital 25 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI17244461CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
68047-753-0168047-753Butalbital and Acetaminophen butalbital and acetaminophenLarken Laboratories, Inc.ANDA203484
68047-753-3068047-753Butalbital and Acetaminophen butalbital and acetaminophenLarken Laboratories, Inc.ANDA203484
69292-303-0169292-303BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenAmici Pharma, Inc.ANDA214088

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA20348468047-753Butalbital and Acetaminophen butalbital and acetaminophenANDALarken Laboratories, Inc.
ANDA21408869292-303BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenANDAAmici Pharma, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 13 matching rows.

NDC11, Source, Active table
NDC11SourceActive
68047075301rxnav_ndcsyes
68047075330rxnav_ndcsyes
69292030301rxnav_ndcsyes
71993030110rxnav_ndcsyes
71993030130rxnav_ndcsyes
68047072201rxnav_historical
68047072230rxnav_historical
70362072201rxnav_historical
70362072230rxnav_historical
70538045001rxnav_historical
70569015001rxnav_historical
70569015030rxnav_historical
73159000301rxnav_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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAmici Pharma, Inc.3280501f-928a-4112-803d-fb9771c865472026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 69292-303-01
ndc (product): 69292-303
ndc11 (package): 69292030301
rxcui: 1724446
Butalbital And AcetaminophenBUTALBITAL AND ACETAMINOPHENLarken Laboratories, Inc.326c83fc-afed-45ad-9c87-f47968fa1d2a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 68047-753-01
ndc (package): 68047-753-30
ndc (product): 68047-753
ndc11 (package): 68047075301
ndc11 (package): 68047075330
rxcui: 1724446

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
326c83fc-afed-45ad-9c87-f47968fa1d2abutalbital 25 MG / acetaminophen 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / butalbital 25 MG Oral Tablet [SCD] · APAP 325 MG / butalbital 25 MG Oral Tablet [SY]317Butalbital and Acetaminophen 50 mg/ 325 mg tablet Butalbital and Acetaminophen 25 mg/ 325 mg tablet ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet Rx only20251015
3280501f-928a-4112-803d-fb9771c86547butalbital 25 MG / acetaminophen 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / butalbital 25 MG Oral Tablet [SCD] · APAP 325 MG / butalbital 25 MG Oral Tablet [SY]31Butalbital and Acetaminophen Tablets20260317

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
3280501f-928a-4112-803d-fb9771c86547Butalbital and Acetaminophen TabletsAmici Pharma, Inc.20260317
326c83fc-afed-45ad-9c87-f47968fa1d2aButalbital and Acetaminophen 50 mg/ 325 mg tablet Butalbital and Acetaminophen 25 mg/ 325 mg tablet ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet Rx onlyLarken Laboratories, Inc.20251015
326c83fc-afed-45ad-9c87-f47968fa1d2aButalbital and Acetaminophen 50 mg/ 325 mg tablet Butalbital and Acetaminophen 25 mg/ 325 mg tablet ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet Rx onlyLarken Laboratories, Inc.20241010
edbbff9a-56ae-4bf8-83aa-a3e41c376f31Butalbital and Acetaminophen 25 mg/ 325 mg tablet, CIII Rx onlyLacer Pharma, LLC20221117
eb338895-ea3d-4950-8819-a28b7a314ebdAllzital (butalbital and acetaminophen 25 mg/ 325 mg) tablet Rx onlySkylar Laboratories, LLC20201116
a054238f-b250-4aec-975d-b64d6685e0cdAllzital (butalbital and acetaminophen 25 mg/ 325 mg) tablet Rx onlyPhlight Pharma, LLC20201116
1758122b-4296-413b-b992-0d3df16eb91eButalbital and Acetaminophen Tablets 25 mg/325 mg Rx onlyAtland Pharmaceuticals, LLC20200129

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN02BEAnilidesATC1-4acetaminophen
FDASPLD001463BarbituratesCHEMhas_chemical_structurebutalbital
FDASPLN0000175693BarbiturateEPChas_epcbutalbital
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD001463BarbituratesCHEMhas_ingredientbutalbital
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withbutalbital
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006261HeadacheDISEASEmay_treatbutalbital
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD011164PorphyriasDISEASEci_withbutalbital
MEDRTD011247PregnancyDISEASEci_withbutalbital
MEDRTN0000000105Neurotransmitter Transporter InteractionsMOAhas_moabutalbital
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008768Decreased Organized Electrical ActivityPEhas_pebutalbital
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH325 MG / 25 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE3
CODESANDAANDA203484
CODESANDAANDA214088
CODESVUID4035449
NAMESPrescribable Synonymbutalbital 25 MG / acetaminophen 325 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon