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 89 of 93 · 1,858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLCb2a14686-6083-46a1-885c-9f7c30e9c6472021-11-30WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen 200mgIBUPROFENAllegiant Healthf3f12b86-89dc-427e-a26f-728be6f73e7b2021-11-16WarningsExact identifier
unii: WK2XYI10QM
infants ibuprofenIBUPROFENH E B2c67fecb-2e69-44d6-8ab8-3251abae72a62021-11-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INCc13455a3-307a-4fe1-e053-2a95a90adf8e2021-11-10WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENRITE AID CORPORATIONa7abac4c-7695-cfe8-e053-2a95a90ac1cd2021-10-30WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen bubblegumIBUPROFENGuardian Drug Company9cb92af9-a829-4f54-b8f5-4e5cb4f165b72021-10-13WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
basic care infants ibuprofenIBUPROFENAmazon.com Services LLC1b5b96cc-40d4-4fb8-b429-cc1a5076fa772021-10-08WarningsExact identifier
unii: WK2XYI10QM
rexall ibuprofenIBUPROFENDolgencorp, LLC869185d5-9f34-4d38-9551-dd0b4fc8557d2021-09-09WarningsExact identifier
unii: WK2XYI10QM
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC1204267a-5505-4257-837b-8902b75713472021-09-07WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Migraine ReliefIBUPROFENBionpharma Inc.662ae0e0-bd44-4db4-8083-fc2e11d49abe2021-08-24WarningsExact identifier
unii: WK2XYI10QM
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLCb17b0aac-55d2-4917-a722-b8587ad643bc2021-08-13WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
dg health childrens ibuprofenIBUPROFENDolgencorp, LLCad8475b3-ace1-4a05-b927-3286a8139cb42021-05-26WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLCb0f03994-b744-4d66-95b7-8c86217882bc2021-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
basic care infants ibuprofenIBUPROFENAmazon.com Services LLC581dca08-a4a4-476a-a7cf-fa0f8630c7772021-05-04WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAphena Pharma Solutions - Tennessee, LLC77adb094-869c-44b4-8a4e-b739ac9cd7012021-04-20Exact identifier
unii: WK2XYI10QM
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLC3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd2021-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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