FDA.reportPublic FDA data

Ibuprofen

Product NDC
11822-6604
11-digit product format
118226604
Labeler code
11822
Product ID
11822-6604_2ceba01b-fad3-4aca-8df7-84bc6372c96e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA072096
Marketing category
ANDA
Marketing start
2020-09-04
Marketing end
2027-02-28
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen

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
11822-6604-1Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10005
11822-6604-2Ibuprofen1 in 1 CARTONTABLET, FILM COATED15
11822-6604-2Ibuprofen50 in 1 BOTTLETABLET, FILM COATED505
11822-6604-3Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1005
11822-6604-3Ibuprofen1 in 1 CARTONTABLET, FILM COATED15
11822-6604-4Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5005
11822-6604-5Ibuprofen1 in 1 CARTONTABLET, FILM COATED15
11822-6604-5Ibuprofen24 in 1 BOTTLETABLET, FILM COATED245
11822-6604-6Ibuprofen200 in 1 BOTTLETABLET, FILM COATED2005
11822-6604-6Ibuprofen1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-6604IBUPROFEN TABLET, FILM COATED [RITE AID CORPORATION]4Current NDC, Legacy NDC, 10 package rows20250410_1dba3cb7-2e3d-4378-93cf-92db8f24f41f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN1dba3cb7-2e3d-4378-93cf-92db8f24f41f5
310965ibuprofen 200 MG Oral TabletSCD1dba3cb7-2e3d-4378-93cf-92db8f24f41f5
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1dba3cb7-2e3d-4378-93cf-92db8f24f41f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-6604-1118226604011000 TABLET, FILM COATED in 1 BOTTLE (11822-6604-1) 2020-09-040000-00-00NoNoCurrent
11822-6604-2118226604021 BOTTLE in 1 CARTON (11822-6604-2) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-04-102027-02-28NoNoHistorical
11822-6604-3118226604031 BOTTLE in 1 CARTON (11822-6604-3) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-04-102026-10-31NoNoHistorical
11822-6604-411822660404500 TABLET, FILM COATED in 1 BOTTLE (11822-6604-4) 2023-04-102027-02-28NoNoHistorical
11822-6604-5118226604051 BOTTLE in 1 CARTON (11822-6604-5) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-11-092026-09-30NoNoHistorical
11822-6604-6118226604061 BOTTLE in 1 CARTON (11822-6604-6) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-11-092026-09-30NoNoHistorical