FDA.reportPublic FDA data

NDC 68210-0200-01 - 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
68210-0200
Requested NDC
68210-0200-01
Package NDCs from labels
68210-0200-1, 68210-0200-01
Manufacturer
SPIRIT PHARMACEUTICALS,LLC
Effective date
2024-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IBUPROFEN - SPIRIT PHARMACEUTICALS,LLCSPIRIT PHARMACEUTICALS,LLC2024-12-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0200-1IBUPROFEN10 in 1 BOTTLECAPSULE, LIQUID FILLED108
68210-0200-1IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0200IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]8Current NDC, Legacy NDC, 2 package rows20250101_2810122e-3c89-49a2-8dac-db3714cb7b45.zip

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 53 of 74 · 1,465 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENBryant Ranch Prepackd0198bdc-fe2b-4b09-8f78-9e5a7f6ae7842024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWildman Business Group9e71f1c1-5272-4209-8974-6c525b1411552024-08-19WarningsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENNuCare Pharmaceuticals,Inc.593d9870-0213-75e6-e053-2991aa0a0eff2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENNuCare Pharmaceuticals Inc.575c275c-3e1a-0572-e053-2991aa0adabd2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGranules India Limitedfd01353d-1d1d-42b5-9a03-575052189bf52024-08-13WarningsExact identifier
unii: WK2XYI10QM
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
dual action pain relieverACETAMINOPHEN AND IBUPROFENBionpharma Inc.1f470b1b-81a9-e59c-e063-6394a90a40552024-08-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFlorida Pharmaceutical Products, LLCc1733fdb-5eed-2094-e053-2995a90a6c8e2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
dual action pain relieverACETAMINOPHEN AND IBUPROFENBionpharma Inc.1f2f8fcf-bf08-2a21-e063-6394a90a9e712024-08-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack60f1c099-5fb5-47e8-b228-11de1ef40f4b2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackffc953f7-ed92-4528-bb2f-72c634c119fa2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC19b06eaf-0d4c-2b4d-e063-6294a90a2eb92024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENP & L Development, LLC6d1c9a64-c83c-4b3d-9245-704b94cb367c2024-07-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLCfaebc392-0fd9-4c71-8471-beba10dda0222024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKROGER COMPANY15e649c4-d75f-e8c1-e063-6294a90a77472024-07-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENActavis Pharma, Inc.3d156d13-25d8-4cfc-8285-5f7ebf48cf452024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENNuCare Pharmaceuticals,Inc.678e2d16-33f3-67a7-e053-2991aa0a11322024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC75d963b9-3675-44ff-bc6b-83461bed1b672024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC57cdd1df-a303-4265-a2d6-1d0b87105a282024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC8df77ead-27eb-4f6f-95a9-f68d3e9cfa712024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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