FDA.reportPublic FDA data

Ibuprofen

Product NDC
21695-067
11-digit product format
216950067
Labeler code
21695
Product ID
21695-067_79505457-733c-4253-ac74-fa864b1a9e55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075682
Marketing category
ANDA
Marketing start
2009-06-10
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
600 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-067-202019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-067-212019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-067-302019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-067-402019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-067-422019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-067-602019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-067-712019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-067-902019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-067-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED202
21695-067-21Ibuprofen21 in 1 BOTTLETABLET, FILM COATED212
21695-067-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED302
21695-067-40Ibuprofen40 in 1 BOTTLETABLET, FILM COATED402
21695-067-42Ibuprofen42 in 1 BOTTLETABLET, FILM COATED422
21695-067-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED602
21695-067-71Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1202
21695-067-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-067-20EA - Each21695-067728fdd36-ad3c-45b4-951e-63a1c6aefee612012-07-24
21695-067-21EA - Each21695-0672f9e1b59-3c9f-4661-86e1-f5a049117c3e12012-07-24
21695-067-30EA - Each21695-06757cae598-915a-42e1-98ec-58c9a7a2232b12012-07-24
21695-067-40EA - Each21695-06729af062b-13e5-49b0-9fcb-6583f1bafff412012-07-24
21695-067-42EA - Each21695-06730d40b7f-8587-4f38-abf6-d3f2f8b3e5e412012-07-24
21695-067-60EA - Each21695-067fcb9457c-2374-4cbd-8da8-e258b34bb1c812012-07-24
21695-067-90EA - Each21695-0672cfeebf0-1230-40b5-acd3-c9ed5d6a93e612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BIBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-067IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2Legacy NDC, 8 package rows20091120_c9ccbafa-99de-49f0-9946-3877bfdc3d7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNc9ccbafa-99de-49f0-9946-3877bfdc3d7c2
197806ibuprofen 600 MG Oral TabletPSNc9ccbafa-99de-49f0-9946-3877bfdc3d7c2
197807ibuprofen 800 MG Oral TabletPSNc9ccbafa-99de-49f0-9946-3877bfdc3d7c2
197805ibuprofen 400 MG Oral TabletSCDc9ccbafa-99de-49f0-9946-3877bfdc3d7c2
197806ibuprofen 600 MG Oral TabletSCDc9ccbafa-99de-49f0-9946-3877bfdc3d7c2
197807ibuprofen 800 MG Oral TabletSCDc9ccbafa-99de-49f0-9946-3877bfdc3d7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-067-202169500672020 in 1 BOTTLEHistorical
21695-067-212169500672121 in 1 BOTTLEHistorical
21695-067-302169500673030 in 1 BOTTLEHistorical
21695-067-402169500674040 in 1 BOTTLEHistorical
21695-067-422169500674242 in 1 BOTTLEHistorical
21695-067-602169500676060 in 1 BOTTLEHistorical
21695-067-7121695006771120 in 1 BOTTLEHistorical
21695-067-902169500679090 in 1 BOTTLEHistorical