FDA.reportPublic FDA data

ibuprofen

Product NDC
56062-647
11-digit product format
560620647
Labeler code
56062
Product ID
56062-647_f6b4482a-2197-468a-8283-6f726c64efb4
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Publix Super Markets Inc
Application
ANDA072096
Marketing category
ANDA
Marketing start
1988-09-15
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
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
56062-647-71ibuprofen1 in 1 CARTONTABLET, FILM COATED16
56062-647-71ibuprofen50 in 1 BOTTLETABLET, FILM COATED506
56062-647-78ibuprofen1 in 1 CARTONTABLET, FILM COATED16
56062-647-78ibuprofen100 in 1 BOTTLETABLET, FILM COATED1006
56062-647-85ibuprofen1 in 1 CARTONTABLET, FILM COATED16
56062-647-85ibuprofen250 in 1 BOTTLETABLET, FILM COATED2506

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, COATED [PUBLIX SUPER MARKETS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-647IBUPROFEN TABLET, FILM COATED [PUBLIX SUPER MARKETS INC]5Current NDC, Legacy NDC, 6 package rows20230815_032decc5-9f7a-4f12-8ca4-a95a79a426c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN032decc5-9f7a-4f12-8ca4-a95a79a426c66
310965ibuprofen 200 MG Oral TabletSCD032decc5-9f7a-4f12-8ca4-a95a79a426c66
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY032decc5-9f7a-4f12-8ca4-a95a79a426c66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-647-71560620647711 BOTTLE in 1 CARTON (56062-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2002-01-310000-00-00NoNoCurrent
56062-647-78560620647781 BOTTLE in 1 CARTON (56062-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-09-150000-00-00NoNoCurrent
56062-647-85560620647851 BOTTLE in 1 CARTON (56062-647-85) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2000-03-200000-00-00NoNoCurrent