FDA.reportPublic FDA data

careone ibuprofen

Product NDC
41520-647
11-digit product format
415200647
Labeler code
41520
Product ID
41520-647_93f2301c-8ebc-4040-89ba-139a1c350da2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Sales Company
Application
ANDA072096
Marketing category
ANDA
Marketing start
2004-04-13
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
careone 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
41520-647-71careone ibuprofen50 in 1 BOTTLETABLET, FILM COATED508
41520-647-71careone ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41520-647-76careone ibuprofen120 in 1 BOTTLETABLET, FILM COATED1208
41520-647-76careone ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41520-647-78careone ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41520-647-78careone ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008
41520-647-85careone ibuprofen250 in 1 BOTTLETABLET, FILM COATED2508
41520-647-85careone ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41520-647-90careone ibuprofen500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
IBUPROFENACTIVE MOIETYWK2XYI10QMCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARE ONE IBUPROFEN (IBUPROFEN) TABLET, COATED [AMERICAN SALES COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-647CAREONE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [AMERICAN SALES COMPANY]7Current NDC, Legacy NDC, 9 package rows20240412_2720b8aa-4361-4cd4-be26-aa6dd1692d12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN2720b8aa-4361-4cd4-be26-aa6dd1692d128
310965ibuprofen 200 MG Oral TabletSCD2720b8aa-4361-4cd4-be26-aa6dd1692d128
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY2720b8aa-4361-4cd4-be26-aa6dd1692d128

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-647-71415200647711 BOTTLE in 1 CARTON (41520-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-04-130000-00-00NoNoCurrent
41520-647-76415200647761 BOTTLE in 1 CARTON (41520-647-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-06-010000-00-00NoNoCurrent
41520-647-78415200647781 BOTTLE in 1 CARTON (41520-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-04-130000-00-00NoNoCurrent
41520-647-85415200647851 BOTTLE in 1 CARTON (41520-647-85) > 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-08-110000-00-00NoNoCurrent
41520-647-9041520064790500 TABLET, FILM COATED in 1 BOTTLE (41520-647-90) 2009-08-140000-00-00NoNoCurrent