FDA.reportPublic FDA data

Motrin IB

Product NDC
52904-947
11-digit product format
529040947
Labeler code
52904
Product ID
52904-947_23d17319-8ae2-4c07-8f9d-df53c2206a19
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Select Corporation
Application
ANDA077349
Marketing category
ANDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
52904-947-042024-01-30C16284748780-11030e365-5c94-111a-e063-dadaa90a10e2Motrin ® IB
52904-947-052024-01-30C16284748780-11030e365-5c94-111a-e063-dadaa90a10e2Motrin ® IB
52904-947-202024-01-30C16284748780-11030e365-5c94-111a-e063-dadaa90a10e2Motrin ® IB
52904-947-252024-01-30C16284748780-11030e365-5c94-111a-e063-dadaa90a10e2Motrin ® IB
52904-947-302024-01-30C16284748780-11030e365-5c94-111a-e063-dadaa90a10e2Motrin ® IB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-947-04Motrin IB2 in 1 POUCHTABLET, FILM COATED21
52904-947-04Motrin IB1 in 1 BLISTER PACKTABLET, FILM COATED11
52904-947-05Motrin IB2 in 1 POUCHTABLET, FILM COATED21
52904-947-05Motrin IB2 in 1 BLISTER PACKTABLET, FILM COATED21
52904-947-20Motrin IB20 in 1 CARTONTABLET, FILM COATED201
52904-947-20Motrin IB2 in 1 POUCHTABLET, FILM COATED21
52904-947-25Motrin IB2 in 1 POUCHTABLET, FILM COATED21
52904-947-25Motrin IB25 in 1 CARTONTABLET, FILM COATED251
52904-947-30Motrin IB2 in 1 POUCHTABLET, FILM COATED21
52904-947-30Motrin IB30 in 1 CARTONTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-947MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [SELECT CORPORATION]1Legacy NDC, 10 package rows20220421_164689bf-cae3-4498-b076-d688ed24b507.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN164689bf-cae3-4498-b076-d688ed24b5071
201126Motrin IB 200 MG Oral TabletPSN164689bf-cae3-4498-b076-d688ed24b5071
201126ibuprofen 200 MG Oral Tablet [Motrin]SBD164689bf-cae3-4498-b076-d688ed24b5071
310965ibuprofen 200 MG Oral TabletSCD164689bf-cae3-4498-b076-d688ed24b5071
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY164689bf-cae3-4498-b076-d688ed24b5071
201126Motrin 200 MG Oral TabletSY164689bf-cae3-4498-b076-d688ed24b5071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52904-947-04529040947041 POUCH in 1 BLISTER PACK (52904-947-04) > 2 TABLET, FILM COATED in 1 POUCH1 pouch2016-07-010000-00-00NoNoCurrent
52904-947-05529040947052 POUCH in 1 BLISTER PACK (52904-947-05) > 2 TABLET, FILM COATED in 1 POUCH2 pouch2016-07-010000-00-00NoNoCurrent
52904-947-205290409472020 POUCH in 1 CARTON (52904-947-20) > 2 TABLET, FILM COATED in 1 POUCH20 pouch2016-07-010000-00-00NoNoCurrent
52904-947-255290409472525 POUCH in 1 CARTON (52904-947-25) > 2 TABLET, FILM COATED in 1 POUCH25 pouch2016-07-010000-00-00NoNoCurrent
52904-947-305290409473030 POUCH in 1 CARTON (52904-947-30) > 2 TABLET, FILM COATED in 1 POUCH30 pouch2016-07-010000-00-00NoNoCurrent