Ibuprofen

Product NDC
11383-151
11-digit product format
113830151
Labeler code
11383
Product ID
11383-151_70453c76-7f71-4edb-9c67-3741dc21d1d1
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Weeks & Leo Co., Inc.
Application
ANDA091239
Marketing category
ANDA
Marketing start
2013-05-17
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11383-151-11Ibuprofen100 in 1 BOTTLETABLET, COATED1001
11383-151-11Ibuprofen1 in 1 CARTONTABLET, COATED11
11383-151-21Ibuprofen200 in 1 BOTTLETABLET, COATED2001
11383-151-21Ibuprofen1 in 1 CARTONTABLET, COATED11
11383-151-50Ibuprofen50 in 1 BOTTLETABLET, COATED501
11383-151-50Ibuprofen1 in 1 CARTONTABLET, COATED11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11383-151IBUPROFEN TABLET, COATED [WEEKS & LEO CO., INC.]1Legacy NDC, 6 package rows20130520_70453c76-7f71-4edb-9c67-3741dc21d1d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN70453c76-7f71-4edb-9c67-3741dc21d1d11
310965ibuprofen 200 MG Oral TabletSCD70453c76-7f71-4edb-9c67-3741dc21d1d11
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY70453c76-7f71-4edb-9c67-3741dc21d1d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11383-151-1111383015111100 in 1 BOTTLEHistorical
11383-151-2111383015121200 in 1 BOTTLEHistorical
11383-151-501138301515050 in 1 BOTTLEHistorical