Motrin IB

Product NDC
53209-2001
11-digit product format
532092001
Labeler code
53209
Product ID
53209-2001_37e92a7b-971f-c212-e063-6394a90ad710
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Morning Star OTC
Application
ANDA077349
Marketing category
ANDA
Marketing start
2025-06-19
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
53209-2001-1Motrin IB2 in 1 BLISTER PACKTABLET, FILM COATED21
53209-2001-2Motrin IB25 in 1 POUCHTABLET, FILM COATED251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126Motrin IB 200 MG Oral TabletPSNe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
310965ibuprofen 200 MG Oral TabletSCDe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126Motrin 200 MG Oral TabletSYe69f00c4-b8ec-4a83-9eea-8cb2835ad7761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53209-2001-1532092001012 in 1 BLISTER PACKHistorical
53209-2001-25320920010225 BLISTER PACK in 1 POUCH (53209-2001-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-2001-1) 25 blister pack2025-06-19NoNoCurrent