FDA.reportPublic FDA data

Ibuprofen

Product NDC
63868-979
11-digit product format
638680979
Labeler code
63868
Product ID
63868-979_17c41cdc-d6d0-40cf-8ac3-ef7ba162b9ba
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
ANDA075010
Marketing category
ANDA
Marketing start
1988-05-24
Marketing end
2028-02-28
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
63868-979-10Ibuprofen1 in 1 CARTONTABLET, FILM COATED117
63868-979-10Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017
63868-979-24Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2417
63868-979-24Ibuprofen1 in 1 CARTONTABLET, FILM COATED117
63868-979-50Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5017
63868-979-50Ibuprofen1 in 1 CARTONTABLET, FILM COATED117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-979-10EA - Each63868-97936c3ead5-7e4d-45be-abe9-dbc6368779b412022-09-12
63868-979-24EA - Each63868-979798d308b-c61f-4cfa-93d9-1fe181337d9212022-10-06
63868-979-50EA - Each63868-97943ed9339-29b1-47d5-a079-3e0abb1a197612022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-979IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]15Current NDC, Legacy NDC, 6 package rows20250430_6521bc47-4d9c-4a5b-b109-3841f3be4b6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN6521bc47-4d9c-4a5b-b109-3841f3be4b6c17
310965ibuprofen 200 MG Oral TabletSCD6521bc47-4d9c-4a5b-b109-3841f3be4b6c17
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY6521bc47-4d9c-4a5b-b109-3841f3be4b6c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-979-10638680979101 BOTTLE, PLASTIC in 1 CARTON (63868-979-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242028-02-28NoNoCurrent
63868-979-24638680979241 BOTTLE, PLASTIC in 1 CARTON (63868-979-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242028-02-28NoNoCurrent
63868-979-50638680979501 BOTTLE, PLASTIC in 1 CARTON (63868-979-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242028-02-28NoNoCurrent