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 86 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
DG Health childrens ibuprofenIBUPROFENDolgencorp, LLC0fd6fcca-cbfe-48af-80dd-2607b5d51b532022-10-13WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Circle K IbuprofenIBUPROFENLil Drug Store Products, Inc791a7375-34b2-449b-9284-3c49a27046192022-10-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.b493bf76-1e8b-4e72-bef6-aca4efc69cbe2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.4d95bccd-8280-4d03-a574-927669c7cda02022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.bb6d0547-c113-42f9-8bf2-c227a55ab7582022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
Circle K IbuprofenIBUPROFENLil Drug Store Products, Inc805d9d80-7de7-49d9-afdb-3a645059fe352022-09-21WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
unii: K679OBS311
IbuprofenIBUPROFENAurohealth LLCe1b49257-d226-457f-8f2d-9a757a65bbcb2022-09-06WarningsExact identifier
unii: WK2XYI10QM
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
unii: 6OZP39ZG8H
unii: K679OBS311
Childrens Ibuprofen Oral SuspensionIBUPROFENPharmaceutical Associates, Inc.7a6832f2-2d80-483c-bde3-e6cacb7c318a2022-08-31WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
betr pain reliefIBUPROFENLive Betr LLC1b709dce-5c71-45e6-b516-d510a0a8c25d2022-08-24WarningsExact identifier
unii: WK2XYI10QM
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLC2c7c5349-06c9-401a-88e9-8f91ddb7f91a2022-08-19WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALStrategic Sourcing Servicesa3062142-db0e-4758-a762-2b2bb05670b12022-08-10WarningsExact identifier
application number: ANDA210602
ndc (package): 70677-0150-2
ndc (package): 70677-0153-1
ndc (package): 70677-0152-1
ndc (package): 70677-0151-1
ndc (package): 70677-0150-1
ndc (product): 70677-0153
ndc (product): 70677-0152
ndc (product): 70677-0150
ndc (product): 70677-0151
ndc11 (package): 70677015301
rxcui: 197803
spl id: e5e79c54-bf94-3d7d-e053-2995a90a3812
spl set id: a3062142-db0e-4758-a762-2b2bb05670b1
unii: WK2XYI10QM
IbuprofenIBUPROFEN TABLET, FILM-COATEDLil' Drug Store Products, Inc.e5bf5e09-7d42-6314-e053-2a95a90a23252022-08-08WarningsExact identifier
unii: WK2XYI10QM
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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