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 6 of 88 · 1,760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d82026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENCVS Pharmacy52193849-d03a-b61b-e063-6394a90ad2772026-07-20WarningsExact identifier
unii: WK2XYI10QM
good sense dual actionACETAMINOPHEN, IBUPROFENL Perrigo Companyb117358c-f4ca-4ea8-95ee-88a42cc050402026-07-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.57a1bf99-5aaf-432d-86ba-5f0e7cfab1a02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENSun Pharmaceutical Industries, Inc.9de61620-6750-4fb6-89a4-fe451ab8d99f2026-07-15WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IbuprofenIBUPROFENStrides Pharma Science Limited38ebacc3-378f-483e-babc-76119677e7df2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215311
ndc (package): 64380-997-01
ndc (package): 64380-997-03
ndc (package): 64380-997-04
ndc (package): 64380-997-02
ndc (product): 64380-997
ndc11 (package): 64380099701
rxcui: 197803
spl id: ac237016-385d-4874-9f6b-795ba4c88489
spl set id: 38ebacc3-378f-483e-babc-76119677e7df
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackf1c88d74-09b0-4b14-baea-106fbbbc54bf2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 107, LLC0387bfaa-daca-48ec-b718-0216a848c16a2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.3ce7549f-e4db-9f89-e063-6294a90a126d2026-07-10WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
unii: WK2XYI10QM
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
unii: 3NXW29V3WO
IbuprofenIBUPROFENSt. Mary's Medical Park Pharmacy0a98cce4-f5c0-12a8-e063-6294a90a4e7e2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.b6a6c940-daf6-4e0e-aefb-35cce87a9a552026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.421156d2-85dc-4680-b2b4-d15b67539e872026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBetter Living Brands, LLC45520969-7a2d-4469-ba25-7db160d50ccf2026-07-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.c0156053-add5-4bd5-b89f-f90df2e73be42026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENSelect Consumer Group55cd65fc-91bf-4979-e063-6294a90ab9b72026-07-04WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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