FDA.reportPublic FDA data

acetaminophen 325 MG / butalbital 50 MG Oral Tablet

RxCUI
197426
RxNorm name
acetaminophen 325 MG / butalbital 50 MG Oral Tablet
Display name
Acetaminophen/Butalbital (Oral Pill)
Full name
acetaminophen 325 MG / butalbital 50 MG Oral Tablet
Term type
SCD
Status
Active
Strength
325-50 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-11-02 18:18:01

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042005
Active start
042005
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
butalbital50 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 50 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 325 MG / butalbital 50 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 325 MG / butalbital 50 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
5 linked values
5CODES
RxCUI1974261CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0603-2540-210603-2540butalbital and acetaminophen butalbital and acetaminophenPar HealthANDA089987
35573-456-0235573-456BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenBurel Pharmaceuticals, LLCANDA214088
68047-721-0168047-721Butalbital And Acetaminophen butalbital and acetaminophenLarken Laboratories, Inc.ANDA203484
68047-721-3068047-721Butalbital And Acetaminophen butalbital and acetaminophenLarken Laboratories, Inc.ANDA203484
69292-302-0169292-302BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenAmici Pharma, Inc.ANDA214088
70752-148-1070752-148BUTALBITAL and ACETAMINOPHEN BUTALBITAL and ACETAMINOPHENQUAGEN PHARMACEUTICALS LLCANDA214291
70752-148-1470752-148BUTALBITAL and ACETAMINOPHEN BUTALBITAL and ACETAMINOPHENQUAGEN PHARMACEUTICALS LLCANDA214291

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0899870603-2540butalbital and acetaminophen butalbital and acetaminophenANDAPar Health
ANDA21408835573-456BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenANDABurel Pharmaceuticals, LLC
ANDA20348468047-721Butalbital And Acetaminophen butalbital and acetaminophenANDALarken Laboratories, Inc.
ANDA21429170752-148BUTALBITAL and ACETAMINOPHEN BUTALBITAL and ACETAMINOPHENANDAQUAGEN PHARMACEUTICALS LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 65 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00603254021rxnav_ndcsyes
35573045602rxnav_ndcsyes
47781062801rxnav_ndcsyes
54879002601rxnav_ndcsyes
68047072101rxnav_ndcsyes
68047072130rxnav_ndcsyes
68071042130rxnav_ndcsyes
68071042160rxnav_ndcsyes
68071042190rxnav_ndcsyes
69292030201rxnav_ndcsyes
70752014810rxnav_ndcsyes
70752014814rxnav_ndcsyes
00086005000rxnav_historical
00086005010rxnav_historical
00086005050rxnav_historical
00143906001rxnav_historical
00143906005rxnav_historical
00187084201rxnav_historical
00187084202rxnav_historical
00591551901rxnav_historical
00591551904rxnav_historical
00682140001rxnav_historical
00682140002rxnav_historical
00682140030rxnav_historical
00756011010rxnav_historical
00756011050rxnav_historical
00879054301rxnav_historical
00879054305rxnav_historical
13517010910rxnav_historical
16590070960rxnav_historical
16590070990rxnav_historical
18837033360rxnav_historical
18837033390rxnav_historical
33358005830rxnav_historical
43199005301rxnav_historical
46672009910rxnav_historical
46672009950rxnav_historical
47781053501rxnav_historical
54868576600rxnav_historical
55289012715rxnav_historical
55289012725rxnav_historical
55887056620rxnav_historical
55887056630rxnav_historical
58016000200rxnav_historical
58016000201rxnav_historical
58016000202rxnav_historical
58016000203rxnav_historical
58016000204rxnav_historical
58016000205rxnav_historical
58016000206rxnav_historical
58016000207rxnav_historical
58016000208rxnav_historical
58016000209rxnav_historical
58016000210rxnav_historical
58016000230rxnav_historical
58016000260rxnav_historical
58016000290rxnav_historical
65234005010rxnav_historical
65234005050rxnav_historical
65243005010rxnav_historical
65243005050rxnav_historical
68115062700rxnav_historical
69499030230rxnav_historical
69499030240rxnav_historical
70362072101rxnav_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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
butalbital and acetaminophenBUTALBITAL AND ACETAMINOPHENPar Healthe619b656-4123-4878-b601-b0edad3c428b2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0603-2540-21
ndc (product): 0603-2540
ndc11 (package): 00603254021
rxcui: 197426
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAmici Pharma, Inc.3280501f-928a-4112-803d-fb9771c865472026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 69292-302-01
ndc (product): 69292-302
ndc11 (package): 69292030201
rxcui: 197426
Butalbital And AcetaminophenBUTALBITAL AND ACETAMINOPHENLarken Laboratories, Inc.326c83fc-afed-45ad-9c87-f47968fa1d2a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 68047-721-30
ndc (package): 68047-721-01
ndc (product): 68047-721
ndc11 (package): 68047072130
ndc11 (package): 68047072101
rxcui: 197426
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENBurel Pharmaceuticals, LLC0a8a6a16-b23f-45d2-b5d4-540264e74d142024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 35573-456-02
ndc (product): 35573-456
ndc11 (package): 35573045602
rxcui: 197426
TenconBUTALBITAL AND ACETAMINOPHENEl Dorado Distributors LLC4e4a9925-67aa-4be7-8bb7-c8b058ffe2232024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197426
BUTALBITAL and ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENQUAGEN PHARMACEUTICALS LLC2eb09253-7f59-401e-afbc-70bb9600fedf2024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70752-148-10
ndc (package): 70752-148-14
ndc (product): 70752-148
ndc11 (package): 70752014810
ndc11 (package): 70752014814
rxcui: 197426

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 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
326c83fc-afed-45ad-9c87-f47968fa1d2abutalbital 50 MG / acetaminophen 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 325 MG / butalbital 50 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
e619b656-4123-4878-b601-b0edad3c428bbutalbital 50 MG / acetaminophen 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 325 MG / butalbital 50 MG Oral Tablet [SY]3720250206
4e4a9925-67aa-4be7-8bb7-c8b058ffe223butalbital 50 MG / acetaminophen 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 325 MG / butalbital 50 MG Oral Tablet [SY]36Tencon20240515
0a8a6a16-b23f-45d2-b5d4-540264e74d14butalbital 50 MG / acetaminophen 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 325 MG / butalbital 50 MG Oral Tablet [SY]33Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx only20241018
2eb09253-7f59-401e-afbc-70bb9600fedfbutalbital 50 MG / acetaminophen 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 325 MG / butalbital 50 MG Oral Tablet [SY]33Butalbital and Acetaminophen Tablets 50 mg/325mg CIIIRX Only20240506
3280501f-928a-4112-803d-fb9771c86547butalbital 50 MG / acetaminophen 325 MG Oral Tablet [PSN] · acetaminophen 325 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 325 MG / butalbital 50 MG Oral Tablet [SY]31Butalbital and Acetaminophen Tablets20260317

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
e619b656-4123-4878-b601-b0edad3c428bPar Health20260806
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
e619b656-4123-4878-b601-b0edad3c428bEndo USA20250206
0a8a6a16-b23f-45d2-b5d4-540264e74d14Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx onlyBurel Pharmaceuticals, LLC20241018
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
2eb09253-7f59-401e-afbc-70bb9600fedfButalbital and Acetaminophen Tablets 50 mg/325mg CIIIRX OnlyQUAGEN PHARMACEUTICALS LLC20240506
0a8a6a16-b23f-45d2-b5d4-540264e74d14Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx onlyBurel Pharmaceuticals, LLC20221215
90b620e5-30c5-a8b9-4319-33fd5b9691beAlvogen, Inc.20211215
ca8a0862-1956-43ad-844d-77153aa09dfbButalbital and Acetaminophen Tablets 50 mg/325 mgMikart, LLC20200917
a9a0955b-bc0e-413a-2417-42e1c91f5500Alvogen, Inc.20190904
6719f42e-59b9-490a-a38d-8a349969bdbaNational Council for Prescription Drug Programs20120724
76379aa6-285a-44ed-8a98-f2ad6777b3c2National Council for Prescription Drug Programs20120724

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 / 50 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE3
CODESANDAANDA089987
CODESANDAANDA203484
CODESANDAANDA214088
CODESANDAANDA214291
CODESSNOMEDCT377594002
CODESVUID4006616
NAMESPrescribable Synonymbutalbital 50 MG / acetaminophen 325 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File