FDA.reportPublic FDA data

acetaminophen 300 MG / butalbital 50 MG Oral Tablet

RxCUI
1249617
RxNorm name
acetaminophen 300 MG / butalbital 50 MG Oral Tablet
Display name
Acetaminophen/Butalbital (Oral Pill)
Full name
acetaminophen 300 MG / butalbital 50 MG Oral Tablet
Term type
SCD
Status
Active
Strength
300-50 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-17 23:46:22

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
052012
Active start
052012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen300 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 300 MG / butalbital 50 MG Oral Tablet1NAMES
RxNorm Nameacetaminophen 300 MG / butalbital 50 MG Oral Tablet1NAMES
RxNorm SynonymAPAP 300 MG / butalbital 50 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
5 linked values
5CODES
RxCUI12496171CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
35573-455-0235573-455BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenBurel Pharmaceuticals, LLCANDA214088
68682-306-0168682-306Butalbital and Acetaminophen Butalbital and Acetaminophen tabletsOceanside PharmaceuticalsANDA090956
69292-301-0169292-301BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenAmici Pharma, Inc.ANDA214088
70752-147-1070752-147BUTALBITAL and ACETAMINOPHEN BUTALBITAL and ACETAMINOPHENQUAGEN PHARMACEUTICALS LLCANDA214305
70752-147-1470752-147BUTALBITAL and ACETAMINOPHEN BUTALBITAL and ACETAMINOPHENQUAGEN PHARMACEUTICALS LLCANDA214305
81005-123-0181005-123BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenAarkish Pharmaceuticals NJ Inc.ANDA214955

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21408835573-455BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenANDABurel Pharmaceuticals, LLC
ANDA09095668682-306Butalbital and Acetaminophen Butalbital and Acetaminophen tabletsANDAOceanside Pharmaceuticals
ANDA21430570752-147BUTALBITAL and ACETAMINOPHEN BUTALBITAL and ACETAMINOPHENANDAQUAGEN PHARMACEUTICALS LLC
ANDA21495581005-123BUTALBITAL AND ACETAMINOPHEN butalbital and acetaminophenANDAAarkish Pharmaceuticals NJ Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 16 matching rows.

NDC11, Source, Active table
NDC11SourceActive
35573045502rxnav_ndcsyes
47781053401rxnav_ndcsyes
47781064401rxnav_ndcsyes
51862053801rxnav_ndcsyes
68682030601rxnav_ndcsyes
69292030101rxnav_ndcsyes
70752014710rxnav_ndcsyes
70752014714rxnav_ndcsyes
81005012301rxnav_ndcsyes
00722707501rxnav_historical
46672085610rxnav_historical
46672085622rxnav_historical
46672085650rxnav_historical
71406010903rxnav_historical
71406010905rxnav_historical
79739707501rxnav_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 · 5 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): 69292-301-01
ndc (product): 69292-301
ndc11 (package): 69292030101
rxcui: 1249617
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENAarkish Pharmaceuticals NJ Inc.82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a62025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 81005-123-01
ndc (product): 81005-123
ndc11 (package): 81005012301
rxcui: 1249617
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENBurel Pharmaceuticals, LLC0a8a6a16-b23f-45d2-b5d4-540264e74d142024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 35573-455-02
ndc (product): 35573-455
ndc11 (package): 35573045502
rxcui: 1249617
BUTALBITAL and ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENQUAGEN PHARMACEUTICALS LLC1f0dbe62-6aea-4323-ad25-c2211f9192532024-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 70752-147-10
ndc (package): 70752-147-14
ndc (product): 70752-147
ndc11 (package): 70752014710
ndc11 (package): 70752014714
rxcui: 1249617
Butalbital and AcetaminophenBUTALBITAL AND ACETAMINOPHEN TABLETSOceanside Pharmaceuticalsd2213ffd-18f6-45f5-9af7-690a977562c42020-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 68682-306-01
ndc (product): 68682-306
ndc11 (package): 68682030601
rxcui: 1249617

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 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a6butalbital 50 MG / acetaminophen 300 MG Oral Tablet [PSN] · acetaminophen 300 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 300 MG / butalbital 50 MG Oral Tablet [SY]36Butalbital and Acetaminophen Tablets 50 mg/ 300 mg20250617
669e3bd0-fbd9-423c-8654-a78fe650e3e2butalbital 50 MG / acetaminophen 300 MG Oral Tablet [PSN] · acetaminophen 300 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 300 MG / butalbital 50 MG Oral Tablet [SY]36Butalbital and Acetaminophen Tablets 50 mg/300 mg20190822
1f0dbe62-6aea-4323-ad25-c2211f919253butalbital 50 MG / acetaminophen 300 MG Oral Tablet [PSN] · acetaminophen 300 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 300 MG / butalbital 50 MG Oral Tablet [SY]34Butalbital and Acetaminophen Tablets20240506
d2213ffd-18f6-45f5-9af7-690a977562c4butalbital 50 MG / acetaminophen 300 MG Oral Tablet [PSN] · acetaminophen 300 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 300 MG / butalbital 50 MG Oral Tablet [SY]34Butalbital and Acetaminophen Tablets 50 mg/300 mg20200402
0a8a6a16-b23f-45d2-b5d4-540264e74d14butalbital 50 MG / acetaminophen 300 MG Oral Tablet [PSN] · acetaminophen 300 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 300 MG / butalbital 50 MG Oral Tablet [SY]33Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx only20241018
3280501f-928a-4112-803d-fb9771c86547butalbital 50 MG / acetaminophen 300 MG Oral Tablet [PSN] · acetaminophen 300 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 300 MG / butalbital 50 MG Oral Tablet [SY]31Butalbital and Acetaminophen Tablets20260317
a24ccca7-e347-44e4-b700-1cc54c525bd3butalbital 50 MG / acetaminophen 300 MG Oral Tablet [PSN] · acetaminophen 300 MG / butalbital 50 MG Oral Tablet [SCD] · APAP 300 MG / butalbital 50 MG Oral Tablet [SY]31Butalbital and Acetaminophen Tablets 50 mg/300 mg20200813

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
3280501f-928a-4112-803d-fb9771c86547Butalbital and Acetaminophen TabletsAmici Pharma, Inc.20260317
82fa5151-d5ee-4ad8-ba7c-a2df8a09e1a6Butalbital and Acetaminophen Tablets 50 mg/ 300 mgAarkish Pharmaceuticals NJ Inc. | AACE Pharmaceuticals, Inc.20250617
0a8a6a16-b23f-45d2-b5d4-540264e74d14Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx onlyBurel Pharmaceuticals, LLC20241018
1f0dbe62-6aea-4323-ad25-c2211f919253Butalbital and Acetaminophen TabletsQUAGEN PHARMACEUTICALS LLC20240506
fc55ae1c-aa76-4c75-a6f2-64fc47a5cebaButalbital and Acetaminophen Tablets 50 mg/300 mgAACE Pharmaceuticals, Inc.20221215
0a8a6a16-b23f-45d2-b5d4-540264e74d14Butalbital and Acetaminophen Tablets, 50 mg/325 mg and 50 mg/300 mg Rx onlyBurel Pharmaceuticals, LLC20221215
adde9439-7399-4706-8237-81ab5658f8f0Mayne Pharma20221003
bff2bcb9-5ddf-9c46-9edf-ea17ea4630e5Butalbital and Acetaminophen TabletsAlvogen Inc.20211215
a24ccca7-e347-44e4-b700-1cc54c525bd3Butalbital and Acetaminophen Tablets 50 mg/300 mgLGM Pharma Solutions, LLC20200813
d2213ffd-18f6-45f5-9af7-690a977562c4Butalbital and Acetaminophen Tablets 50 mg/300 mgOceanside Pharmaceuticals | LGM Pharma Solutions, LLC20200402
98a517d8-43d6-4920-83e0-b9483864a6b4Butalbital and Acetaminophen Tablets 50 mg / 300 mgAlvogen Inc.20200121
91257639-85a1-404d-bfb1-b63a3f4521e7Mikart, LLC20200118
669e3bd0-fbd9-423c-8654-a78fe650e3e2Butalbital and Acetaminophen Tablets 50 mg/300 mgNexgen Pharma, Inc.20190822

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_STRENGTH300 MG / 50 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE3
CODESANDAANDA090956
CODESANDAANDA214088
CODESANDAANDA214305
CODESANDAANDA214955
CODESVUID4032528
NAMESPrescribable Synonymbutalbital 50 MG / acetaminophen 300 MG Oral Tablet
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