FDA.reportPublic FDA data

MOTRIN IB

Product NDC
50269-000
11-digit product format
502690000
Labeler code
50269
Product ID
50269-000_2a458f6d-e744-1cd1-e063-6394a90a36a5
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
JC World Bell Wholesale Co., Inc.
Application
ANDA077349
Marketing category
ANDA
Marketing start
2018-12-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MOTRIN IB
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui201126, 310965

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50269-000-01MOTRIN IB1 in 1 BLISTER PACKTABLET, FILM COATED17
50269-000-01MOTRIN IB6 in 1 BOXTABLET, FILM COATED67
50269-000-25MOTRIN IB25 in 1 BOXTABLET, FILM COATED257
50269-000-25MOTRIN IB2 in 1 POUCHTABLET, FILM COATED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50269-000MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JC WORLD BELL WHOLESALE CO., INC.]7Current NDC, Legacy NDC, 4 package rows20250101_4e7516e1-184a-45e9-b908-228121f163f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN4e7516e1-184a-45e9-b908-228121f163f67
201126Motrin IB 200 MG Oral TabletPSN4e7516e1-184a-45e9-b908-228121f163f67
201126ibuprofen 200 MG Oral Tablet [Motrin]SBD4e7516e1-184a-45e9-b908-228121f163f67
310965ibuprofen 200 MG Oral TabletSCD4e7516e1-184a-45e9-b908-228121f163f67
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY4e7516e1-184a-45e9-b908-228121f163f67
201126Motrin 200 MG Oral TabletSY4e7516e1-184a-45e9-b908-228121f163f67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50269-000-01502690000016 BLISTER PACK in 1 BOX (50269-000-01) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH6 blister pack2018-12-100000-00-00NoNoCurrent
50269-000-255026900002525 POUCH in 1 BOX (50269-000-25) / 2 TABLET, FILM COATED in 1 POUCH25 pouch2018-12-100000-00-00NoNoCurrent