FDA.reportPublic FDA data

NDC 0143-9150-01 - COMBOGESIC IV

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0143-9150
Requested NDC
0143-9150-01
Package NDCs from labels
0143-9150-01, 0143-9150-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-11-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
acetaminophen and ibuprofen injection - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2024-11-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9150-01COMBOGESIC IV100 mL in 1 VIALINJECTION1005
0143-9150-10COMBOGESIC IV10 in 1 CARTONINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9150COMBOGESIC IV (ACETAMINOPHEN AND IBUPROFEN INJECTION) INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, 2 package rows20240508_be408a5a-48e4-43c0-9cb1-bbf830b54f5b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9150-01ML - Milliliter0143-9150d37cb79f-d97e-4b29-b379-877624c3a16a12024-02-14
0143-9150-10ML - Milliliter0143-9150238ef363-e14c-4a25-8da1-9bcd3130a0bc12024-02-14

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 36 of 214 · 4,268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Childrens Mighty Chews Night Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC2ce31244-9c6c-b7dd-e063-6394a90a31a82026-05-13WarningsExact identifier
unii: 362O9ITL9D
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.60c731c6-4dc4-490a-8469-0b7e58e563a12026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
AcetaminophenACETAMINOPHENAcetris Pharma Holdings, LLCdacbe2eb-f412-4629-a8ff-237c7fd10ab62026-05-13WarningsExact identifier
unii: 362O9ITL9D
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.13fd4401-1821-4f2b-a44e-96aa2fa75b5c2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc2ac53cc7-000f-41fd-b799-4e6d6886fe622026-05-13WarningsExact identifier
unii: 362O9ITL9D
nighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Inc2201d5c0-bd51-47a7-9775-916b185736232026-05-13WarningsExact identifier
unii: 362O9ITL9D
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEChain Drug Marketing Association, Inc.17216bf3-bed0-4d7a-994e-76a0e4c79c5c2026-05-13WarningsExact identifier
unii: 362O9ITL9D
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLCf868e4a0-e9fb-4e6a-9984-29a2182462412026-05-13WarningsExact identifier
unii: 362O9ITL9D
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEMeijer Distribution Inc582fa36b-6d0c-4ff3-80ab-6e0da4b209e42026-05-13WarningsExact identifier
unii: 362O9ITL9D
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.25d9f5fc-4d95-4018-add8-ba696b6079b22026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Motrin InfantsIBUPROFENKenvue Brands LLCc57f6ded-c0bd-45ae-823a-4c02ce334d982026-05-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENQPharma Incfd8b82a7-96fe-8bf5-e053-6394a90a39352026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC14c56f3d-67fd-45ef-a16b-f276047228832026-05-12WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe7eeb71-e219-4c84-ac06-98c3a40b14dc2026-05-12WarningsExact identifier
unii: 362O9ITL9D
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51a45db8-2bee-6fd0-e063-6394a90ab5872026-05-12WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Mucinex Fast-Max Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8a790eeb-7d7d-4a94-9103-6ed09c04d5962026-05-12WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd03ef2fd-1a08-42c0-b69d-fd4e4285ccd32026-05-12WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2ef9d5de-e99e-4398-bf97-c7bef94498fa2026-05-12WarningsExact identifier
unii: 362O9ITL9D
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7c18e95-8d7b-4550-9a20-fc704a114adb2026-05-12WarningsExact identifier
unii: 362O9ITL9D
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECVS Pharmacy289ec101-c9a3-45f1-b2cd-8eaf8e5801302026-05-12WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.