FDA.reportPublic FDA data

Ibuprofen

Product NDC
50844-393
11-digit product format
508440393
Labeler code
50844
Product ID
50844-393_a09c3263-2d8e-49f0-8e62-e0e1ccc4089d
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
ANDA075139
Marketing category
ANDA
Marketing start
1999-03-01
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
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
50844-393-02Ibuprofen1 in 1 CARTONTABLET, FILM COATED113
50844-393-02Ibuprofen12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1213
50844-393-06Ibuprofen200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20013
50844-393-08Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2413
50844-393-08Ibuprofen1 in 1 CARTONTABLET, FILM COATED113
50844-393-12Ibuprofen1 in 1 CARTONTABLET, FILM COATED113
50844-393-12Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10013
50844-393-14Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50013
50844-393-15Ibuprofen1 in 1 CARTONTABLET, FILM COATED113
50844-393-15Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5013
50844-393-16Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100013
50844-393-20Ibuprofen225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22513
50844-393-58Ibuprofen750 in 1 BOTTLE, PLASTICTABLET, FILM COATED75013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
IbuprofenACTIVE MOIETYWK2XYI10QMIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
HypromelloseINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
PolydextroseINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
Polyethylene GlycolINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN (IBUPROFEN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-393IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]12Current NDC, Legacy NDC, 13 package rows20241115_d1f20e10-0128-f2e5-1a03-6da5d7288a4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNd1f20e10-0128-f2e5-1a03-6da5d7288a4e13
310965ibuprofen 200 MG Oral TabletSCDd1f20e10-0128-f2e5-1a03-6da5d7288a4e13
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYd1f20e10-0128-f2e5-1a03-6da5d7288a4e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50844-393-02508440393021 BOTTLE, PLASTIC in 1 CARTON (50844-393-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent
50844-393-0650844039306200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-393-06) 1999-03-01NoNoCurrent
50844-393-08508440393081 BOTTLE, PLASTIC in 1 CARTON (50844-393-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent
50844-393-12508440393121 BOTTLE, PLASTIC in 1 CARTON (50844-393-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent
50844-393-1450844039314500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-393-14) 1999-03-010000-00-00NoNoCurrent
50844-393-15508440393151 BOTTLE, PLASTIC in 1 CARTON (50844-393-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent
50844-393-16508440393161000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-393-16) 1999-03-010000-00-00NoNoCurrent
50844-393-2050844039320225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-393-20) 1999-03-010000-00-00NoNoCurrent
50844-393-5850844039358750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-393-58) 1999-03-010000-00-00NoNoCurrent