FDA.reportPublic FDA data

Ibuprofen (NSAID)

Product NDC
21695-065
11-digit product format
216950065
Labeler code
21695
Product ID
21695-065_7b4858fc-fea6-4e4c-886e-a2febe1ed2c3
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen (NSAID)
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA071333
Marketing category
ANDA
Marketing start
2009-12-16
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
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
21695-065-062019-09-24C16284748780-1934fe258-4920-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID)
21695-065-142019-09-24C16284748780-1934fe258-4920-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID)
21695-065-282019-09-24C16284748780-1934fe258-4920-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID)
21695-065-302019-09-24C16284748780-1934fe258-4920-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID)
21695-065-502019-09-24C16284748780-1934fe258-4920-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID)
21695-065-602019-09-24C16284748780-1934fe258-4920-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID)
21695-065-902019-09-24C16284748780-1934fe258-4920-48b1-e053-8cdaa90a720aIbuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-065-06Ibuprofen (NSAID)Pain Releiver/ Fever Reducer6 in 1 BOTTLETABLET61
21695-065-14Ibuprofen (NSAID)Pain Releiver/ Fever Reducer14 in 1 BOTTLETABLET141
21695-065-28Ibuprofen (NSAID)Pain Releiver/ Fever Reducer28 in 1 BOTTLETABLET281
21695-065-30Ibuprofen (NSAID)Pain Releiver/ Fever Reducer30 in 1 BOTTLETABLET301
21695-065-50Ibuprofen (NSAID)Pain Releiver/ Fever Reducer50 in 1 BOTTLETABLET501
21695-065-60Ibuprofen (NSAID)Pain Releiver/ Fever Reducer60 in 1 BOTTLETABLET601
21695-065-90Ibuprofen (NSAID)Pain Releiver/ Fever Reducer90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-065-14EA - Each21695-065ec67d892-4165-4604-83f6-1eaeb524c03d12012-07-24
21695-065-28EA - Each21695-065132a04d6-ba56-4a5f-8c3e-659bf946031112012-07-24
21695-065-30EA - Each21695-065f03a3aba-b664-4918-ab1d-de9d584a2bc012012-07-24
21695-065-50EA - Each21695-065a5c3bc78-46f9-4fd0-a3ba-8c8e6f09a4ac12012-07-24
21695-065-60EA - Each21695-06545ddc4d8-2a68-4c6a-9ad2-0de1f006cc6712012-07-24
21695-065-90EA - Each21695-065881ed50b-4a37-4d56-8893-94ea6e9c176312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-065IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER (IBUPROFEN (NSAID)) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 7 package rows20110629_7b4858fc-fea6-4e4c-886e-a2febe1ed2c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN7b4858fc-fea6-4e4c-886e-a2febe1ed2c31
310965ibuprofen 200 MG Oral TabletSCD7b4858fc-fea6-4e4c-886e-a2febe1ed2c31
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY7b4858fc-fea6-4e4c-886e-a2febe1ed2c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-065-06216950065066 in 1 BOTTLEHistorical
21695-065-142169500651414 in 1 BOTTLEHistorical
21695-065-282169500652828 in 1 BOTTLEHistorical
21695-065-302169500653030 in 1 BOTTLEHistorical
21695-065-502169500655050 in 1 BOTTLEHistorical
21695-065-602169500656060 in 1 BOTTLEHistorical
21695-065-902169500659090 in 1 BOTTLEHistorical