FDA.reportPublic FDA data

Ibuprofen

Product NDC
71335-3121
11-digit product format
713353121
Labeler code
71335
Product ID
71335-3121_00e9051f-6b68-4770-9007-e9fb67a8da38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-05-23
Substance
IBUPROFEN
Active strength
600 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
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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
71335-3121-0Ibuprofen21 in 1 BOTTLETABLET, FILM COATED211
71335-3121-1Ibuprofen20 in 1 BOTTLETABLET, FILM COATED201
71335-3121-2Ibuprofen15 in 1 BOTTLETABLET, FILM COATED151
71335-3121-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED301
71335-3121-4Ibuprofen40 in 1 BOTTLETABLET, FILM COATED401
71335-3121-5Ibuprofen60 in 1 BOTTLETABLET, FILM COATED601
71335-3121-6Ibuprofen90 in 1 BOTTLETABLET, FILM COATED901
71335-3121-7Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1201
71335-3121-8Ibuprofen50 in 1 BOTTLETABLET, FILM COATED501
71335-3121-9Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN886c974c-0d32-4a1b-8f54-40c2c12efa451
197806ibuprofen 600 MG Oral TabletSCD886c974c-0d32-4a1b-8f54-40c2c12efa451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3121-07133531210021 TABLET, FILM COATED in 1 BOTTLE (71335-3121-0) 2026-04-13NoNoHistorical
71335-3121-17133531210120 TABLET, FILM COATED in 1 BOTTLE (71335-3121-1) 2026-04-13NoNoHistorical
71335-3121-27133531210215 TABLET, FILM COATED in 1 BOTTLE (71335-3121-2) 2026-04-13NoNoHistorical
71335-3121-37133531210330 TABLET, FILM COATED in 1 BOTTLE (71335-3121-3) 2026-04-13NoNoHistorical
71335-3121-47133531210440 TABLET, FILM COATED in 1 BOTTLE (71335-3121-4) 2026-04-13NoNoHistorical
71335-3121-57133531210560 TABLET, FILM COATED in 1 BOTTLE (71335-3121-5) 2026-04-13NoNoHistorical
71335-3121-67133531210690 TABLET, FILM COATED in 1 BOTTLE (71335-3121-6) 2026-04-13NoNoHistorical
71335-3121-771335312107120 TABLET, FILM COATED in 1 BOTTLE (71335-3121-7) 2026-04-13NoNoHistorical
71335-3121-87133531210850 TABLET, FILM COATED in 1 BOTTLE (71335-3121-8) 2026-04-13NoNoHistorical
71335-3121-971335312109100 TABLET, FILM COATED in 1 BOTTLE (71335-3121-9) 2026-04-13NoNoHistorical