FDA.reportPublic FDA data

Ibuprofen

Product NDC
53943-291
11-digit product format
539430291
Labeler code
53943
Product ID
53943-291_8f6a852c-e79d-4dad-aa48-af0bab58cd2f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Discount Drug Mart
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
53943-291-12Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10012
53943-291-12Ibuprofen1 in 1 CARTONTABLET, FILM COATED112
53943-291-14Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50012
53943-291-15Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5012
53943-291-15Ibuprofen1 in 1 CARTONTABLET, FILM COATED112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-291IBUPROFEN TABLET, FILM COATED [DISCOUNT DRUG MART]11Current NDC, Legacy NDC, 5 package rows20250418_cffad7af-44f5-4e54-9e46-c3c5d4ca182f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNcffad7af-44f5-4e54-9e46-c3c5d4ca182f12
310965ibuprofen 200 MG Oral TabletSCDcffad7af-44f5-4e54-9e46-c3c5d4ca182f12
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYcffad7af-44f5-4e54-9e46-c3c5d4ca182f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53943-291-12539430291121 BOTTLE, PLASTIC in 1 CARTON (53943-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
53943-291-1453943029114500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53943-291-14) 1988-05-240000-00-00NoNoCurrent
53943-291-15539430291151 BOTTLE, PLASTIC in 1 CARTON (53943-291-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent