FDA.reportPublic FDA data

Ibuprofen

Product NDC
21695-068
11-digit product format
216950068
Labeler code
21695
Product ID
21695-068_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
800 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
21695-068-002019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-202019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-212019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-282019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-302019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-402019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-422019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-452019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-602019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-722019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP
21695-068-902019-09-24C16284748780-1934fe258-4b7b-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-068-00Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1002
21695-068-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED202
21695-068-21Ibuprofen21 in 1 BOTTLETABLET, FILM COATED212
21695-068-28Ibuprofen28 in 1 BOTTLETABLET, FILM COATED282
21695-068-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED302
21695-068-40Ibuprofen40 in 1 BOTTLETABLET, FILM COATED402
21695-068-42Ibuprofen42 in 1 BOTTLETABLET, FILM COATED422
21695-068-45Ibuprofen45 in 1 BOTTLETABLET, FILM COATED452
21695-068-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED602
21695-068-72Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1202
21695-068-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-068-00EA - Each21695-0689fc2859e-1347-49a9-b23f-7c2b97dd7aaa12012-07-24
21695-068-20EA - Each21695-068f9a30c39-2fc8-44a7-962c-a2b211eafb3c12012-07-24
21695-068-21EA - Each21695-068b0739614-c267-4d7c-bc10-8176720a5b9712012-07-24
21695-068-28EA - Each21695-068e1e0577c-b54a-4f37-a73e-302f89e93b8c12012-07-24
21695-068-30EA - Each21695-0685b998345-7d28-456d-8b73-c081c1d6c95912012-07-24
21695-068-40EA - Each21695-068d5bcd92c-a962-42a4-bf5d-4c6ed2769f1a12012-07-24
21695-068-42EA - Each21695-068cc854f79-ffd1-4c25-a280-97643fd1470612012-07-24
21695-068-45EA - Each21695-068c173ebc0-bbbe-4207-bb0d-0dcfe5c9b3f512012-07-24
21695-068-60EA - Each21695-068c21b0afc-0da4-449b-9830-0b60d6305a9212012-07-24
21695-068-72EA - Each21695-0689a12b1cf-3583-44f9-aa48-33ce0658548f12012-07-24
21695-068-90EA - Each21695-06831787af8-4773-4f92-b304-ea68ba987eb712012-07-24

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
21695-068IBUPROFEN TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]2Legacy NDC, 11 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
21695-068-0021695006800100 in 1 BOTTLEHistorical
21695-068-202169500682020 in 1 BOTTLEHistorical
21695-068-212169500682121 in 1 BOTTLEHistorical
21695-068-282169500682828 in 1 BOTTLEHistorical
21695-068-302169500683030 in 1 BOTTLEHistorical
21695-068-402169500684040 in 1 BOTTLEHistorical
21695-068-422169500684242 in 1 BOTTLEHistorical
21695-068-452169500684545 in 1 BOTTLEHistorical
21695-068-602169500686060 in 1 BOTTLEHistorical
21695-068-7221695006872120 in 1 BOTTLEHistorical
21695-068-902169500689090 in 1 BOTTLEHistorical