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 43 of 213 · 4,247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.e83d14cc-9b90-40ce-a00a-2702d8a8968f2026-04-17WarningsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
unii: 362O9ITL9D
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
unii: 362O9ITL9D
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCb297aff8-a08b-4d37-b168-800a56564cbd2026-04-16WarningsExact identifier
unii: 362O9ITL9D
Childrens TylenolACETAMINOPHENKenvue Brands LLC9782fe86-d72a-4231-b1ba-d3f3b4ee49e32026-04-16WarningsExact identifier
unii: 362O9ITL9D
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
unii: 362O9ITL9D
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
unii: 362O9ITL9D
care one ibuprofenIBUPROFENAmerican Sales Companyd26d2766-6d4c-462b-ae8b-ef8d87acd6332026-04-16WarningsExact identifier
unii: WK2XYI10QM
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
unii: 362O9ITL9D
Childrens IbuprofenIBUPROFENCardinal Health 107, LLC9291857c-30b3-414b-99e1-9c127e72c0d42026-04-16WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen childrensIBUPROFENHyVee Inc55f8def6-f7de-4b3e-a92a-5cd9e68a46a12026-04-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENST. MARY'S MEDICAL PARK PHARMACY4e67aef4-c3ac-232a-e063-6394a90a3a852026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rompe Pecho MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc4f86985c-48f3-2148-e063-6394a90ae2f12026-04-15WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPreferrred Pharmaceuticals Inc.cb92ebea-86be-4bdf-a608-50be8be770fb2026-04-15WarningsExact identifier
unii: 362O9ITL9D
EXTRA STRENGTH PAIN RELIEFACETAMINOPHENPreferred Pharmaceuticals Inc.e18294f5-8fd5-4ac6-802c-f6d257e8bee72026-04-15WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b6abfbbb-9826-4cd6-940f-3a314480a5a52026-04-15WarningsExact identifier
unii: 362O9ITL9D
Good Sense Pain ReliefACETAMINOPHENPreferred Pharmaceuticals Inc.36708cac-c076-4514-bfa1-9db6918749002026-04-15WarningsExact identifier
unii: 362O9ITL9D
IBUIBUPROFENGolden State Medical Supply, Inc.bbf4821d-f9fc-9f6e-e053-2a95a90a52532026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sinus and HeadacheACETAMINOPHEN, PHENYLEPHRINE HCLWalgreen Company2115f095-2d75-4e02-a6af-22dd693e08402026-04-14WarningsExact identifier
unii: 362O9ITL9D
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5515148f-3e1d-4b03-89fa-40967d5082922026-04-14WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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