FDA.reportPublic FDA data

NDC 70677-0153-01 - Ibuprofen Oral

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
70677-0153
Requested NDC
70677-0153-01
Package NDCs from labels
70677-0153-1, 70677-0153-01
Manufacturer
Strategic Sourcing Services | AptaPharma Inc.
Effective date
2022-08-10
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 mL (OTC)Strategic Sourcing Services | AptaPharma Inc.2022-08-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0153-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1181
70677-0153-1Ibuprofen Oral1 in 1 CARTONSUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0153IBUPROFEN ORAL (IBUPROFEN ORAL) SUSPENSION [STRATEGIC SOURCING SERVICES]1Current NDC, Legacy NDC, 2 package rows20220811_a3062142-db0e-4758-a762-2b2bb05670b1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0153-1ML - Milliliter70677-0153b4e8be0e-e5f7-4a79-9455-79aaa2fb6e4f12023-02-06

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 91 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPURACAP PHARMACEUTICAL LLC9e86b6e5-5374-4699-a0d1-a4c3d069f2622020-01-17WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
childrens ibuprofenIBUPROFENH E Be7e2b766-6d05-49e2-9e88-72454b8579352019-12-27WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
RenacidinCITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATEUnited-Guardian, Inc.13a9bbba-db21-4cba-991c-5d8afaf2ed742019-12-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Ibuprofen 200mgIBUPROFEN 200MGAllegiant Health2e33a153-0a3f-4b88-b193-d63e0b792ccc2019-12-12WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC73eb763e-ce21-4cff-854f-3297f20f1f612019-12-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC40501966-419a-4ccd-b7c9-5581cbe47a972019-12-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPuraCap Pharmaceutical LLCb6e14f73-1f19-4cfa-8858-136a38ee32d02019-12-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC67e09ad5-e010-4aa1-b86e-9b22331bf33b2019-12-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC24ef6819-f098-4d01-bfe7-6ffa4aa0e6712019-12-10WarningsExact identifier
unii: WK2XYI10QM
Congestion ReliefIBUPROFEN, PHENYLEPHRINE HCLMeijer Distribution Inc84f932b6-0aee-4cf9-b4b9-213560c42c1d2019-12-05WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd50bab3b2-f710-46ff-96cd-1ec4d46585292019-11-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltdf42506f7-896c-47a9-a4b1-ed72434d7aa02019-11-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd58bff8bf-5a4e-4390-9c03-e266d31deb6b2019-11-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltddaf579dc-91d1-4950-b637-c1a34f5542c52019-11-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSam's West, Inc.90c301ad-7bbd-4e21-8054-35596b208cd42019-11-21WarningsExact identifier
unii: WK2XYI10QM
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.2557199a-5f60-49d8-b093-1e07002112432019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.794f724c-87f0-49c1-9b26-c9e4919783132019-11-18Exact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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