FDA.reportPublic FDA data

Ibuprofen

Product NDC
59779-291
11-digit product format
597790291
Labeler code
59779
Product ID
59779-291_d8135ca1-dfde-4e34-b547-94b7eec64eec
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
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
59779-291-03Ibuprofen10 in 1 VIALTABLET, FILM COATED1025
59779-291-05Ibuprofen400 in 1 BOTTLE, PLASTICTABLET, FILM COATED40025
59779-291-10Ibuprofen10 in 1 BOTTLETABLET, FILM COATED1025
59779-291-10Ibuprofen1 in 1 PACKAGETABLET, FILM COATED125
59779-291-12Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10025
59779-291-12Ibuprofen1 in 1 CARTONTABLET, FILM COATED125
59779-291-15Ibuprofen1 in 1 CARTONTABLET, FILM COATED125
59779-291-15Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5025
59779-291-29Ibuprofen150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15025
59779-291-29Ibuprofen1 in 1 CARTONTABLET, FILM COATED125
59779-291-90Ibuprofen1 in 1 CARTONTABLET, FILM COATED125
59779-291-90Ibuprofen120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12025
59779-291-96Ibuprofen400 in 1 BOTTLE, PLASTICTABLET, FILM COATED40025
59779-291-96Ibuprofen2 in 1 PACKAGETABLET, FILM COATED225
59779-291-98Ibuprofen2 in 1 PACKAGETABLET, FILM COATED225
59779-291-98Ibuprofen10 in 1 BOTTLETABLET, FILM COATED1025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-291IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]23Current NDC, Legacy NDC, 16 package rows20240623_8d9f11a5-ca98-4280-9c6a-093d32e60ace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN8d9f11a5-ca98-4280-9c6a-093d32e60ace25
310965ibuprofen 200 MG Oral TabletSCD8d9f11a5-ca98-4280-9c6a-093d32e60ace25
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY8d9f11a5-ca98-4280-9c6a-093d32e60ace25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-291-035977902910310 in 1 VIALHistorical
59779-291-0559779029105400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59779-291-05) 1988-05-240000-00-00NoNoCurrent
59779-291-10597790291101 BOTTLE in 1 PACKAGE (59779-291-10) / 10 TABLET, FILM COATED in 1 BOTTLE1 bottle1988-05-240000-00-00NoNoCurrent
59779-291-12597790291121 BOTTLE, PLASTIC in 1 CARTON (59779-291-12) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
59779-291-15597790291151 BOTTLE, PLASTIC in 1 CARTON (59779-291-15) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
59779-291-2959779029129150 in 1 BOTTLE, PLASTICHistorical
59779-291-90597790291901 BOTTLE, PLASTIC in 1 CARTON (59779-291-90) > 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
59779-291-96597790291962 BOTTLE, PLASTIC in 1 PACKAGE (59779-291-96) > 400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
59779-291-98597790291982 BOTTLE in 1 PACKAGE (59779-291-98) / 10 TABLET, FILM COATED in 1 BOTTLE2 bottle1988-05-240000-00-00NoNoCurrent