FDA.reportPublic FDA data

NDC 64380-997-01 - Ibuprofen

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
64380-997
Requested NDC
64380-997-01
Package NDCs from labels
64380-997-03, 64380-997-04, 64380-997-01, 64380-997-02
Manufacturer
Strides Pharma Science Limited | Strides Pharma Global Pte. Ltd.
Effective date
2026-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen Oral Suspension, USP 100 mg/5 mLStrides Pharma Science Limited | Strides Pharma Global Pte. Ltd.2026-07-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-997-01Ibuprofen5 mL in 1 CUPSUSPENSION57
64380-997-02Ibuprofen10 in 1 TRAYSUSPENSION107
64380-997-03Ibuprofen1 in 1 CARTONSUSPENSION17
64380-997-03Ibuprofen118 mL in 1 BOTTLESUSPENSION1187
64380-997-04Ibuprofen473 mL in 1 BOTTLESUSPENSION4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-997IBUPROFEN SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, Legacy NDC, 5 package rows20231012_38ebacc3-378f-483e-babc-76119677e7df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-997-03ML - Milliliter64380-997d4b4c938-a0cb-40ef-8adf-d563c12744e612024-02-14
64380-997-04ML - Milliliter64380-99771790c5b-2169-44ea-bf5c-064f0851a0bb12024-02-14

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 9 of 88 · 1,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dye-free pain reliefIBUPROFENBionpharma Inc.c46c9c36-8844-7b50-e053-2a95a90aa0e92026-06-23WarningsExact identifier
unii: WK2XYI10QM
dye-free pain reliefIBUPROFENBionpharma Inc.4227d0b7-846a-dcb0-e063-6294a90af7d72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.3c1c1b65-f57f-62b0-e063-6294a90a10212026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3802982a-2373-9ca3-e063-6394a90a0ab72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.4573753d-117b-a6f2-e063-6394a90ae2f92026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3ed7faff-fd48-0a83-e063-6394a90aab142026-06-23WarningsExact identifier
unii: WK2XYI10QM
Pain ReliefIBUPROFENAlbertsons Companiesf9deaeb7-efb3-4019-e053-6394a90a33d62026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.bc15fea8-0d86-4546-e053-2995a90abee32026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a13ac87b-b395-685e-e053-2a95a90ab5d32026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWhole Foods Market, INC.32348505-744c-fbfd-e063-6394a90a82d72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGEN1afcf0c6-bd41-4621-9e44-d97b81221c122026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGENa13cee82-1c4e-0cbe-e053-2a95a90a3ab82026-06-23WarningsExact identifier
unii: WK2XYI10QM
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTopco Associates, LLC59a88ca7-eb37-46de-9134-a5a6d330bd492026-06-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx54d9e1fc-507d-1859-e063-6394a90a8c6b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 107, LLC8ea0e303-3967-4d71-8255-ac42a841ce282026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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