FDA.reportPublic FDA data

Ibuprofen

Product NDC
68016-634
11-digit product format
680160634
Labeler code
68016
Product ID
68016-634_4ce3d600-a2ba-4e98-b513-e6e5884ae9a2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Consortium
Application
ANDA075010
Marketing category
ANDA
Marketing start
1988-05-24
Marketing end
2027-02-28
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-634-00Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100013
68016-634-05Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50013
68016-634-10Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10013
68016-634-10Ibuprofen1 in 1 CARTONTABLET, FILM COATED113
68016-634-24Ibuprofen1 in 1 CARTONTABLET, FILM COATED113
68016-634-24Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2413
68016-634-25Ibuprofen250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25013
68016-634-50Ibuprofen1 in 1 CARTONTABLET, FILM COATED113
68016-634-50Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-634-00EA - Each68016-634bfb29314-52f1-4911-be46-36228b67c60712022-06-06
68016-634-10EA - Each68016-63451c8a127-00af-40b8-af74-240218ef225412022-06-06
68016-634-50EA - Each68016-634c81c5e84-f159-4bc8-a05c-e20c8e4f84c912022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-634IBUPROFEN TABLET, FILM COATED [CHAIN DRUG CONSORTIUM]12Current NDC, Legacy NDC, 9 package rows20250108_6c593a9c-680e-4645-8e8f-d8d044c92ca1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN6c593a9c-680e-4645-8e8f-d8d044c92ca113
310965ibuprofen 200 MG Oral TabletSCD6c593a9c-680e-4645-8e8f-d8d044c92ca113
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY6c593a9c-680e-4645-8e8f-d8d044c92ca113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-634-00680160634001000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-00) 1988-05-242027-02-28NoNoCurrent
68016-634-0568016063405500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-05) 1988-05-242027-02-28NoNoCurrent
68016-634-10680160634101 BOTTLE, PLASTIC in 1 CARTON (68016-634-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242027-02-28NoNoCurrent
68016-634-24680160634241 BOTTLE, PLASTIC in 1 CARTON (68016-634-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242027-02-28NoNoCurrent
68016-634-2568016063425250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-25) 1988-05-242027-02-28NoNoCurrent
68016-634-50680160634501 BOTTLE, PLASTIC in 1 CARTON (68016-634-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242027-02-28NoNoCurrent