FDA.reportPublic FDA data

Berkley and Jensen Ibuprofen

Product NDC
68391-604
11-digit product format
683910604
Labeler code
68391
Product ID
68391-604_379127e9-fb91-4556-9bc5-29f7ddc37577
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
BJWC
Application
ANDA072096
Marketing category
ANDA
Marketing start
2007-06-20
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
Berkley and Jensen 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
68391-604-62Berkley and Jensen Ibuprofen24 in 1 BOTTLETABLET, FILM COATED249
68391-604-62Berkley and Jensen Ibuprofen1 in 1 CARTONTABLET, FILM COATED19
68391-604-90Berkley and Jensen Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5009

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
IBUPROFENACTIVE MOIETYWK2XYI10QMBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET [BJWC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-604BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BJWC]8Current NDC, Legacy NDC, 3 package rows20250412_cda57e42-6106-46ee-82d1-479a692ee5bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNcda57e42-6106-46ee-82d1-479a692ee5bb9
310965ibuprofen 200 MG Oral TabletSCDcda57e42-6106-46ee-82d1-479a692ee5bb9
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYcda57e42-6106-46ee-82d1-479a692ee5bb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-604-62683910604621 BOTTLE in 1 CARTON (68391-604-62) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2010-07-270000-00-00NoNoCurrent
68391-604-9068391060490500 TABLET, FILM COATED in 1 BOTTLE (68391-604-90) 2007-06-200000-00-00NoNoCurrent