FDA.reportPublic FDA data

Ibuprofen

Product NDC
50844-291
11-digit product format
508440291
Labeler code
50844
Product ID
50844-291_beb6ea94-7f3d-4d13-90a5-e717aa719050
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
ANDA075010
Marketing category
ANDA
Marketing start
1988-05-24
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
Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM

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
50844-291-01Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-01Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
50844-291-02Ibuprofen12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1221
50844-291-02Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-03Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1021
50844-291-08Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2421
50844-291-08Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-10Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-10Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4021
50844-291-11Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6021
50844-291-11Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-12Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-12Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10021
50844-291-13Ibuprofen250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25021
50844-291-13Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-14Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50021
50844-291-15Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5021
50844-291-15Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-16Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100021
50844-291-17Ibuprofen300 in 1 BOTTLE, PLASTICTABLET, FILM COATED30021
50844-291-24Ibuprofen2 in 1 POUCHTABLET, FILM COATED221
50844-291-29Ibuprofen150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15021
50844-291-29Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-50Ibuprofen50 in 1 CARTONTABLET, FILM COATED5021
50844-291-99Ibuprofen250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25021

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-291IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]20Current NDC, Legacy NDC, 25 package rows20240628_57b39311-bc20-ace6-75a9-a07a9311b373.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN57b39311-bc20-ace6-75a9-a07a9311b37321
310965ibuprofen 200 MG Oral TabletSCD57b39311-bc20-ace6-75a9-a07a9311b37321
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY57b39311-bc20-ace6-75a9-a07a9311b37321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-291-01508440291011 BOTTLE, PLASTIC in 1 CARTON (50844-291-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-02508440291021 BOTTLE, PLASTIC in 1 CARTON (50844-291-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-035084402910310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-03) 1988-05-240000-00-00NoNoCurrent
50844-291-08508440291081 BOTTLE, PLASTIC in 1 CARTON (50844-291-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-10508440291101 BOTTLE, PLASTIC in 1 CARTON (50844-291-10) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-11508440291111 BOTTLE, PLASTIC in 1 CARTON (50844-291-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-12508440291121 BOTTLE, PLASTIC in 1 CARTON (50844-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-13508440291131 BOTTLE, PLASTIC in 1 CARTON (50844-291-13) / 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-1450844029114500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-14) 1988-05-240000-00-00NoNoCurrent
50844-291-15508440291151 BOTTLE, PLASTIC in 1 CARTON (50844-291-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-16508440291161000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-16) 1988-05-240000-00-00NoNoCurrent
50844-291-1750844029117300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-17) 1988-05-24NoNoCurrent
50844-291-24508440291242 in 1 POUCHHistorical
50844-291-29508440291291 BOTTLE, PLASTIC in 1 CARTON (50844-291-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-505084402915050 POUCH in 1 CARTON (50844-291-50) / 2 TABLET, FILM COATED in 1 POUCH (50844-291-24) 50 pouch1988-05-24NoNoCurrent
50844-291-9950844029199250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-99) 1988-05-24NoNoCurrent