Ibuprofen

Product NDC
11822-0393
11-digit product format
118220393
Labeler code
11822
Product ID
11822-0393_3892fd51-10c4-4ea1-96d6-60de077ec269
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
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
2027-12-31
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
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
11822-0393-1Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10022
11822-0393-1Ibuprofen1 in 1 CARTONTABLET, FILM COATED122
11822-0393-2Ibuprofen225 in 1 BOTTLE, PLASTICTABLET, FILM COATED22522
11822-0393-4Ibuprofen2 in 1 BLISTER PACKTABLET, FILM COATED222
11822-0393-4Ibuprofen1 in 1 CARTONTABLET, FILM COATED122
11822-0393-5Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5022
11822-0393-5Ibuprofen1 in 1 CARTONTABLET, FILM COATED122

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
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN 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
11822-0393IBUPROFEN TABLET, FILM COATED [RITE AID CORPORATION]21Current NDC, Legacy NDC, 7 package rows20250417_72e11f2d-a348-4c12-9cd8-1e6f0f6f7399.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN72e11f2d-a348-4c12-9cd8-1e6f0f6f739922
310965ibuprofen 200 MG Oral TabletSCD72e11f2d-a348-4c12-9cd8-1e6f0f6f739922
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY72e11f2d-a348-4c12-9cd8-1e6f0f6f739922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0393-1118220393011 BOTTLE, PLASTIC in 1 CARTON (11822-0393-1) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent
11822-0393-211822039302225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (11822-0393-2) 1999-03-01NoNoCurrent
11822-0393-4118220393041 BLISTER PACK in 1 CARTON (11822-0393-4) > 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack1999-03-010000-00-00NoNoCurrent
11822-0393-5118220393051 BOTTLE, PLASTIC in 1 CARTON (11822-0393-5) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent