FDA.reportPublic FDA data

ibuprofen

Product NDC
33358-187
11-digit product format
333580187
Labeler code
33358
Product ID
33358-187_13171729-20a2-4569-928f-dd38b8eb89dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
RxChange Co.
Application
ANDA090796
Marketing category
ANDA
Marketing start
2014-11-09
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33358-187-152020-01-31C16284748780-19d75b9d0-930a-f424-e053-dadaa90a57ce373aad4c-45a6-4e69-8791-d4f93c2f645c
33358-187-302020-01-31C16284748780-19d75b9d0-930a-f424-e053-dadaa90a57ce373aad4c-45a6-4e69-8791-d4f93c2f645c
33358-187-602020-01-31C16284748780-19d75b9d0-930a-f424-e053-dadaa90a57ce373aad4c-45a6-4e69-8791-d4f93c2f645c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-187-15ibuprofen15 in 1 BOTTLETABLET152
33358-187-30ibuprofen30 in 1 BOTTLETABLET302
33358-187-60ibuprofen60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-187-15EA - Each33358-187997c9249-9630-4be2-a1c2-7f5d66cd4bcb12014-12-01
33358-187-30EA - Each33358-187e7be4b7f-6fd8-4dc3-abd1-cd17ed35c23812014-12-01
33358-187-60EA - Each33358-1872e13b021-3b3d-41b4-a5b1-2f50cef8ddd412014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ibuprofenACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [RXCHANGE CO.]2
ibuprofenACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [RXCHANGE CO.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [RXCHANGE CO.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [RXCHANGE CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [RXCHANGE CO.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [RXCHANGE CO.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET [RXCHANGE CO.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [RXCHANGE CO.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [RXCHANGE CO.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET [RXCHANGE CO.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [RXCHANGE CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-187IBUPROFEN TABLET [RXCHANGE CO.]2Legacy NDC, 3 package rows20141114_373aad4c-45a6-4e69-8791-d4f93c2f645c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN373aad4c-45a6-4e69-8791-d4f93c2f645c2
197806ibuprofen 600 MG Oral TabletSCD373aad4c-45a6-4e69-8791-d4f93c2f645c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-187-153335801871515 in 1 BOTTLEHistorical
33358-187-303335801873030 in 1 BOTTLEHistorical
33358-187-603335801876060 in 1 BOTTLEHistorical