FDA.reportPublic FDA data

Ibuprofen

Product NDC
33358-188
11-digit product format
333580188
Labeler code
33358
Product ID
33358-188_6c185dc7-5920-4293-b8b4-e090787debae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
RxChange Co.
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33358-188-002020-01-31C16284748780-19d75b9d0-3928-f424-e053-dadaa90a57ceIbuprofen Tablets, USP RX Only
33358-188-302020-01-31C16284748780-19d75b9d0-3928-f424-e053-dadaa90a57ceIbuprofen Tablets, USP RX Only
33358-188-602020-01-31C16284748780-19d75b9d0-3928-f424-e053-dadaa90a57ceIbuprofen Tablets, USP RX Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-188-00Ibuprofen100 in 1 BOTTLETABLET1001
33358-188-30Ibuprofen30 in 1 BOTTLETABLET301
33358-188-60Ibuprofen60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-188-00EA - Each33358-188e9fb1c23-796f-464e-9b95-61c60c35606312014-12-01
33358-188-30EA - Each33358-18851fab9e7-e7f2-494d-8fb8-4c678a471e1e12014-12-01
33358-188-60EA - Each33358-188ffa86789-26e4-4fb1-b7b4-14a1364d718a12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [RXCHANGE CO.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [RXCHANGE CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-188IBUPROFEN TABLET [RXCHANGE CO.]1Legacy NDC, 3 package rows20141111_db056a0b-4e2d-4e62-a80c-d85b4e3660cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNdb056a0b-4e2d-4e62-a80c-d85b4e3660cf1
197807ibuprofen 800 MG Oral TabletSCDdb056a0b-4e2d-4e62-a80c-d85b4e3660cf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-188-0033358018800100 in 1 BOTTLEHistorical
33358-188-303335801883030 in 1 BOTTLEHistorical
33358-188-603335801886060 in 1 BOTTLEHistorical