FDA.reportPublic FDA data

Ibuprofen

Product NDC
11822-0291
11-digit product format
118220291
Labeler code
11822
Product ID
11822-0291_b7b180f9-803d-4ffc-b9a4-384fee40cf4f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
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
11822-0291-0Ibuprofen2 in 1 BLISTER PACKTABLET, FILM COATED221
11822-0291-0Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
11822-0291-1Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10021
11822-0291-1Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
11822-0291-2Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
11822-0291-2Ibuprofen12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1221
11822-0291-3Ibuprofen200 in 1 BOTTLE, PLASTICTABLET, FILM COATED20021
11822-0291-3Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
11822-0291-4Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50021
11822-0291-5Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
11822-0291-5Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5021
11822-0291-6Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
11822-0291-6Ibuprofen16 in 1 BOTTLE, PLASTICTABLET, FILM COATED1621
11822-0291-7Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
11822-0291-7Ibuprofen250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25021
11822-0291-8Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2421
11822-0291-8Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
11822-0291-9Ibuprofen150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15021
11822-0291-9Ibuprofen1 in 1 CARTONTABLET, FILM COATED121

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [RITE AID]6
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [RITE AID]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [RITE AID]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [RITE AID]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [RITE AID]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [RITE AID]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [RITE AID]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [RITE AID]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [RITE AID]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [RITE AID]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0291IBUPROFEN TABLET, FILM COATED [RITE AID CORPORATION]20Current NDC, Legacy NDC, 19 package rows20240623_d9e698f3-c450-4eaa-9cfd-6f48c2656081.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNd9e698f3-c450-4eaa-9cfd-6f48c265608121
310965ibuprofen 200 MG Oral TabletSCDd9e698f3-c450-4eaa-9cfd-6f48c265608121
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYd9e698f3-c450-4eaa-9cfd-6f48c265608121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0291-0118220291001 BLISTER PACK in 1 CARTON (11822-0291-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1988-05-242021-09-04NoNoCurrent
11822-0291-1118220291011 BOTTLE, PLASTIC in 1 CARTON (11822-0291-1) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
11822-0291-2118220291021 BOTTLE, PLASTIC in 1 CARTON (11822-0291-2) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
11822-0291-3118220291031 BOTTLE in 1 CARTON (11822-0291-3) > 200 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-05-240000-00-00NoNoCurrent
11822-0291-411822029104500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-0291-4) 1988-05-240000-00-00NoNoCurrent
11822-0291-5118220291051 BOTTLE, PLASTIC in 1 CARTON (11822-0291-5) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
11822-0291-6118220291061 BOTTLE, PLASTIC in 1 CARTON (11822-0291-6) > 16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242021-09-06NoNoCurrent
11822-0291-7118220291071 BOTTLE, PLASTIC in 1 CARTON (11822-0291-7) > 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242022-02-06NoNoCurrent
11822-0291-8118220291081 BOTTLE, PLASTIC in 1 CARTON (11822-0291-8) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
11822-0291-9118220291091 BOTTLE, PLASTIC in 1 CARTON (11822-0291-9) > 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent