FDA.reportPublic FDA data

IBUPROFEN

Product NDC
41226-610
11-digit product format
412260610
Labeler code
41226
Product ID
41226-610_15f50daf-492d-49be-e063-6294a90ae922
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Kroger Company
Application
ANDA079205
Marketing category
ANDA
Marketing start
2021-06-12
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
41226-610-20IBUPROFEN200 in 1 BOTTLECAPSULE, LIQUID FILLED2003
41226-610-23IBUPROFEN20 in 1 BOTTLECAPSULE, LIQUID FILLED203
41226-610-23IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED13
41226-610-66IBUPROFEN160 in 1 BOTTLECAPSULE, LIQUID FILLED1603
41226-610-80IBUPROFEN80 in 1 BOTTLECAPSULE, LIQUID FILLED803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-610IBUPROFEN CAPSULE, LIQUID FILLED [KROGER COMPANY]3Current NDC, Legacy NDC, 5 package rows20240415_bc178013-ab2e-04f5-e053-2995a90a1ed4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNbc178013-ab2e-04f5-e053-2995a90a1ed43
310964ibuprofen 200 MG Oral CapsuleSCDbc178013-ab2e-04f5-e053-2995a90a1ed43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-610-2041226061020200 CAPSULE, LIQUID FILLED in 1 BOTTLE (41226-610-20) 2024-04-15NoNoCurrent
41226-610-23412260610231 BOTTLE in 1 CARTON (41226-610-23) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-15NoNoCurrent
41226-610-6641226061066160 CAPSULE, LIQUID FILLED in 1 BOTTLE (41226-610-66) 2021-06-120000-00-00NoNoCurrent
41226-610-804122606108080 CAPSULE, LIQUID FILLED in 1 BOTTLE (41226-610-80) 2024-04-15NoNoCurrent