Ibuprofen

Product NDC
76168-012
11-digit product format
761680012
Labeler code
76168
Product ID
76168-012_62377580-5148-43ee-936f-0624149301d7
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Velocity Pharma
Application
ANDA091239
Marketing category
ANDA
Marketing start
2012-07-01
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-012-082020-01-31C16284748780-19d75b9d0-e01a-f424-e053-dadaa90a57ceIbuprofen Tablets, USP 200mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-012-08Ibuprofen1 in 1 CARTONTABLET, COATED11
76168-012-08Ibuprofen40 in 1 BOTTLETABLET, COATED401

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33AIBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990IBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN TABLET, COATED [VELOCITY PHARMA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, COATED [VELOCITY PHARMA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-012IBUPROFEN TABLET, COATED [VELOCITY PHARMA]1Legacy NDC, 2 package rows20130523_83cd5cd5-94e0-4d2c-b6f9-bd1a113643ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN83cd5cd5-94e0-4d2c-b6f9-bd1a113643ab1
310965ibuprofen 200 MG Oral TabletSCD83cd5cd5-94e0-4d2c-b6f9-bd1a113643ab1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY83cd5cd5-94e0-4d2c-b6f9-bd1a113643ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76168-012-08761680012081 in 1 CARTONHistorical