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 12 of 214 · 4,268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pressure, Pain and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.7d42e164-86e9-4baa-a389-3271cf99920e2026-08-03WarningsExact identifier
unii: 362O9ITL9D
IbuprofenIBUPROFENNUVICARE LLC7905edc1-2a45-4adc-a7bc-42b1ddb6ba592026-08-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2026-07-31WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122026-07-31WarningsExact identifier
unii: WK2XYI10QM
Stona for ChildrenACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.18f3d694-9dff-407e-a264-916dbd201f9a2026-07-31WarningsExact identifier
unii: 362O9ITL9D
cold and flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEMeijer Distribution Inc5519e918-71cb-4430-ae57-e03cd5ac60022026-07-31WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
unii: 362O9ITL9D
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
unii: 362O9ITL9D
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
unii: 362O9ITL9D
IbuprofenIBUPROFENAmneal Pharmaceuticals LLC17577b3b-e755-45d1-8b53-775d058578b22026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLC53f7a9c8-f40e-19b2-e063-6394a90a86952026-07-29WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
unii: 362O9ITL9D
IbuprofenIBUPROFENHarris Teeter637210f0-6494-4656-8b2b-14d7476cb1272026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHarris Teeter14515409-736f-4119-b6a0-cb19ee2e948e2026-07-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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