FDA.reportPublic FDA data

Ibuprofen

Product NDC
63868-773
11-digit product format
638680773
Labeler code
63868
Product ID
63868-773_c2bb3799-d8e4-4130-973e-9b1b0d7db096
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
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

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
63868-773-05Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50017
63868-773-10Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017
63868-773-10Ibuprofen1 in 1 CARTONTABLET, FILM COATED117
63868-773-24Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2417
63868-773-24Ibuprofen1 in 1 CARTONTABLET, FILM COATED117
63868-773-50Ibuprofen1 in 1 CARTONTABLET, FILM COATED117
63868-773-50Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-773-05EA - Each63868-773d10dc70c-a475-487a-866f-e35c18c2525012022-07-06
63868-773-10EA - Each63868-7733d3b4425-c4c8-4cce-bc54-8ca94e069e2512022-10-06
63868-773-24EA - Each63868-773755e261c-396f-4641-8910-95b4aec9689f12022-10-06
63868-773-50EA - Each63868-77388ed4564-2b56-4510-a588-49761b9141ae12022-09-12

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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN 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
63868-773IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]16Current NDC, Legacy NDC, 7 package rows20250428_bfda6547-19b2-4230-87a1-a68fbec740b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNbfda6547-19b2-4230-87a1-a68fbec740b417
310965ibuprofen 200 MG Oral TabletSCDbfda6547-19b2-4230-87a1-a68fbec740b417
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYbfda6547-19b2-4230-87a1-a68fbec740b417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-773-0563868077305500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63868-773-05) 1988-05-240000-00-00NoNoCurrent
63868-773-10638680773101 BOTTLE, PLASTIC in 1 CARTON (63868-773-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
63868-773-24638680773241 BOTTLE, PLASTIC in 1 CARTON (63868-773-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242027-06-01NoNoCurrent
63868-773-50638680773501 BOTTLE, PLASTIC in 1 CARTON (63868-773-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-242027-06-01NoNoCurrent