FDA.reportPublic FDA data

NDC 70677-0150-01 - 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
70677-0150
Requested NDC
70677-0150-01
Package NDCs from labels
70677-0150-1, 70677-0150-2, 70677-0150-01
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
70677-0150-1Ibuprofen Oral118 mL in 1 BOTTLESUSPENSION1181
70677-0150-1Ibuprofen Oral1 in 1 CARTONSUSPENSION11
70677-0150-2Ibuprofen Oral1 in 1 CARTONSUSPENSION11
70677-0150-2Ibuprofen Oral237 mL in 1 BOTTLESUSPENSION2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0150IBUPROFEN ORAL (IBUPROFEN ORAL) SUSPENSION [STRATEGIC SOURCING SERVICES]1Current NDC, Legacy NDC, 4 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
70677-0150-1ML - Milliliter70677-0150a2259fb3-e1c5-4f28-861f-988a940ca04812023-02-06
70677-0150-2ML - Milliliter70677-0150d79f7395-198d-4247-be5a-5cfc12257af512023-02-06

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 59 of 94 · 1,870 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen19d3af1c-9dd5-48d9-bd5c-05cc8745e8362025-01-04WarningsExact identifier
unii: WK2XYI10QM
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen7cd838e1-85da-4510-86f0-9d8bc913e8102025-01-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergenb8f43352-f771-4722-b843-f3e29f77c7c02025-01-03WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergena07c45b4-dc98-4b73-a1c1-84b108cf37e92025-01-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack9b98fc28-6cba-4b22-8d4a-9c7735d346b42025-01-03WarningsExact identifier
application number: ANDA210602
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepackb9968d61-bd5d-4573-825a-7630f86eb7c62025-01-03WarningsExact identifier
application number: ANDA210602
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack5c817d24-2dd3-468e-9678-311d038c7b4a2025-01-03WarningsExact identifier
application number: ANDA210602
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAsclemed USA, Inc.41123df3-97ac-4c4f-9a89-f76ec03898bb2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.9b02607a-6fab-5205-e053-2a95a90afa262025-01-02Exact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fc871659-ce41-1be6-e053-6294a90aa5e42025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Prevention Oncology Mouth RinseGLYCERINPrevention Health Sciences, Inc.1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c2025-01-01WarningsExact identifier
unii: PDC6A3C0OX
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
unii: 6DC9Q167V3
CLENZIDERM THERAPEUTIC MOISTURIZERGLYCERINObagi Cosmeceuticals LLCd60e22e3-831e-4787-a82c-e7763c2875532025-01-01WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd998f2fcf-0b40-4304-929f-7f2fa42f66d02024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197803
unii: WK2XYI10QM
Ibuprofen, Caseys 4goodIBUPROFEN TABLETSLil' Drug Store Products, Inc.04b3ad8b-bdf9-47f3-e063-6294a90ac3502024-12-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC09972806-e064-238d-e063-6394a90a74342024-12-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9af7f4-6314-6217-e053-2995a90a5a0f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCb33caad1-8d40-16f2-e053-2a95a90a1b2d2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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