FDA.reportPublic FDA data

Ibuprofen

Product NDC
11822-4258
11-digit product format
118224258
Labeler code
11822
Product ID
11822-4258_cf674005-a266-40ec-86eb-8195d1f3ebce
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
RITE AID CORPORATION
Application
ANDA207753
Marketing category
ANDA
Marketing start
2022-06-24
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
11822-4258-1Ibuprofen20 in 1 BOTTLECAPSULE203
11822-4258-1Ibuprofen1 in 1 CARTONCAPSULE13
11822-4258-2Ibuprofen40 in 1 BOTTLECAPSULE403
11822-4258-2Ibuprofen1 in 1 CARTONCAPSULE13
11822-4258-3Ibuprofen1 in 1 CARTONCAPSULE13
11822-4258-3Ibuprofen80 in 1 BOTTLECAPSULE803
11822-4258-4Ibuprofen160 in 1 BOTTLECAPSULE1603
11822-4258-5Ibuprofen300 in 1 BOTTLECAPSULE3003
11822-4258-6Ibuprofen200 in 1 BOTTLE, PLASTICCAPSULE2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-4258IBUPROFEN CAPSULE [RITE AID CORPORATION]3Current NDC, Legacy NDC, 9 package rows20230507_de158883-1175-18fc-e053-2995a90a3c96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNde158883-1175-18fc-e053-2995a90a3c963
310964ibuprofen 200 MG Oral CapsuleSCDde158883-1175-18fc-e053-2995a90a3c963

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-4258-1118224258011 BOTTLE in 1 CARTON (11822-4258-1) / 20 CAPSULE in 1 BOTTLE1 bottle2022-06-240000-00-00NoNoCurrent
11822-4258-2118224258021 BOTTLE in 1 CARTON (11822-4258-2) / 40 CAPSULE in 1 BOTTLE1 bottle2022-06-240000-00-00NoNoCurrent
11822-4258-3118224258031 BOTTLE in 1 CARTON (11822-4258-3) / 80 CAPSULE in 1 BOTTLE1 bottle2022-06-240000-00-00NoNoCurrent
11822-4258-411822425804160 CAPSULE in 1 BOTTLE (11822-4258-4) 160 capsule2022-06-240000-00-00NoNoCurrent
11822-4258-511822425805300 CAPSULE in 1 BOTTLE (11822-4258-5) 300 capsule2022-06-240000-00-00NoNoCurrent
11822-4258-611822425806200 CAPSULE in 1 BOTTLE, PLASTIC (11822-4258-6) 200 capsule2023-04-12NoNoCurrent