FDA.reportPublic FDA data

Motrin IB

Product NDC
50580-230
11-digit product format
505800230
Labeler code
50580
Product ID
50580-230_4003a46c-d99c-72f4-e063-6394a90ab2db
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
ANDA077349
Marketing category
ANDA
Marketing start
2016-07-01
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-230-01Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-01Motrin IB50 in 1 BOTTLETABLET, FILM COATED5015
50580-230-02Motrin IB60 in 1 BOTTLETABLET, FILM COATED6015
50580-230-02Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-03Motrin IB100 in 1 BOTTLETABLET, FILM COATED10015
50580-230-03Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-04Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-04Motrin IB225 in 1 BOTTLETABLET, FILM COATED22515
50580-230-05Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-05Motrin IB300 in 1 BOTTLETABLET, FILM COATED30015
50580-230-06Motrin IB500 in 1 BOTTLETABLET, FILM COATED50015
50580-230-06Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-07Motrin IB1 in 1 CARTONTABLET, FILM COATED115
50580-230-07Motrin IB24 in 1 BOTTLETABLET, FILM COATED2415
50580-230-08Motrin IB2 in 1 POUCHTABLET, FILM COATED215
50580-230-09Motrin IB2 in 1 POUCHTABLET, FILM COATED215
50580-230-09Motrin IB50 in 1 CARTONTABLET, FILM COATED5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-230-01EA - Each50580-230cc8f08de-0241-475b-a545-b0a755cb1af312018-04-19
50580-230-02EA - Each50580-230b0995e76-9209-4ee6-a3df-52dac753035112017-03-06
50580-230-03EA - Each50580-2309b1cf925-49e6-4fc4-8bc0-5214192c4f8312018-05-09
50580-230-04EA - Each50580-2307762e942-27c6-4845-ad02-dd99aa0860c012024-04-05
50580-230-06EA - Each50580-23087541607-8b7c-4ea4-bab2-4e4d9200867012016-12-07
50580-230-07EA - Each50580-230ce62c3eb-301b-4537-9973-a909356d679012023-12-05
50580-230-09EA - Each50580-2302ceccfbe-9a6a-44b6-a475-80dde15586a512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-230MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [KENVUE BRANDS LLC]14Current NDC, Legacy NDC, 17 package rows20241109_d21129f8-4d96-4e36-bc39-a534306dd77e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNd21129f8-4d96-4e36-bc39-a534306dd77e15
201126Motrin IB 200 MG Oral TabletPSNd21129f8-4d96-4e36-bc39-a534306dd77e15
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDd21129f8-4d96-4e36-bc39-a534306dd77e15
310965ibuprofen 200 MG Oral TabletSCDd21129f8-4d96-4e36-bc39-a534306dd77e15
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYd21129f8-4d96-4e36-bc39-a534306dd77e15
201126Motrin 200 MG Oral TabletSYd21129f8-4d96-4e36-bc39-a534306dd77e15
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
310965ibuprofen 200 MG Oral TabletPSNafa87bb5-7fcb-4ccd-acac-f7931242181f4
201126Motrin IB 200 MG Oral TabletPSNafa87bb5-7fcb-4ccd-acac-f7931242181f4
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDafa87bb5-7fcb-4ccd-acac-f7931242181f4
310965ibuprofen 200 MG Oral TabletSCDafa87bb5-7fcb-4ccd-acac-f7931242181f4
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYafa87bb5-7fcb-4ccd-acac-f7931242181f4
201126Motrin 200 MG Oral TabletSYafa87bb5-7fcb-4ccd-acac-f7931242181f4
310965ibuprofen 200 MG Oral TabletPSNf70c1b68-61c8-b333-e053-6294a90aadaa1
310965ibuprofen 200 MG Oral TabletPSNe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
310965ibuprofen 200 MG Oral TabletPSN164689bf-cae3-4498-b076-d688ed24b5071
201126Motrin IB 200 MG Oral TabletPSN164689bf-cae3-4498-b076-d688ed24b5071
201126Motrin IB 200 MG Oral TabletPSNe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126Motrin IB 200 MG Oral TabletPSNf70c1b68-61c8-b333-e053-6294a90aadaa1
201126ibuprofen 200 MG Oral Tablet [Motrin]SBD164689bf-cae3-4498-b076-d688ed24b5071
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126ibuprofen 200 MG Oral Tablet [Motrin]SBDf70c1b68-61c8-b333-e053-6294a90aadaa1
310965ibuprofen 200 MG Oral TabletSCDe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
310965ibuprofen 200 MG Oral TabletSCDf70c1b68-61c8-b333-e053-6294a90aadaa1
310965ibuprofen 200 MG Oral TabletSCD164689bf-cae3-4498-b076-d688ed24b5071
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY164689bf-cae3-4498-b076-d688ed24b5071
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYf70c1b68-61c8-b333-e053-6294a90aadaa1
201126Motrin 200 MG Oral TabletSY164689bf-cae3-4498-b076-d688ed24b5071
201126Motrin 200 MG Oral TabletSYe69f00c4-b8ec-4a83-9eea-8cb2835ad7761
201126Motrin 200 MG Oral TabletSYf70c1b68-61c8-b333-e053-6294a90aadaa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-230-01505800230011 BOTTLE in 1 CARTON (50580-230-01) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-02505800230021 BOTTLE in 1 CARTON (50580-230-02) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-03505800230031 BOTTLE in 1 CARTON (50580-230-03) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-04505800230041 BOTTLE in 1 CARTON (50580-230-04) / 225 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-05505800230051 BOTTLE in 1 CARTON (50580-230-05) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-06505800230061 BOTTLE in 1 CARTON (50580-230-06) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-07-010000-00-00NoNoCurrent
50580-230-07505800230071 BOTTLE in 1 CARTON (50580-230-07) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-07-170000-00-00NoNoCurrent
50580-230-08505800230082 TABLET, FILM COATED in 1 POUCH (50580-230-08) 2017-06-300000-00-00NoNoCurrent
50580-230-095058002300950 POUCH in 1 CARTON (50580-230-09) / 2 TABLET, FILM COATED in 1 POUCH50 pouch2017-04-240000-00-00NoNoCurrent