FDA.reportPublic FDA data

Ibuprofen

Product NDC
71335-0690
11-digit product format
713350690
Labeler code
71335
Product ID
71335-0690_2f612a58-8c48-4d8a-9819-6e2bca3934cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
71335-0690-1Ibuprofen20 in 1 BOTTLETABLET, FILM COATED2010
71335-0690-2Ibuprofen30 in 1 BOTTLETABLET, FILM COATED3010
71335-0690-3Ibuprofen40 in 1 BOTTLETABLET, FILM COATED4010
71335-0690-4Ibuprofen60 in 1 BOTTLETABLET, FILM COATED6010
71335-0690-5Ibuprofen90 in 1 BOTTLETABLET, FILM COATED9010
71335-0690-6Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12010
71335-0690-7Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10010
71335-0690-8Ibuprofen21 in 1 BOTTLETABLET, FILM COATED2110
71335-0690-9Ibuprofen15 in 1 BOTTLETABLET, FILM COATED1510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0690-2EA - Each71335-06905354b084-5170-4a02-b917-8604e016ec6d12018-08-13
71335-0690-3EA - Each71335-069013932f46-e711-49bf-a66b-174d31be8cea12025-09-12
71335-0690-4EA - Each71335-06900c072971-8a4b-4462-b4e1-d51513bafcdc12019-05-02
71335-0690-5EA - Each71335-0690a7ec1041-a9f0-4ac2-bf83-fcdbfe3de5da12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0690IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 9 package rows20240809_60f1c099-5fb5-47e8-b228-11de1ef40f4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN60f1c099-5fb5-47e8-b228-11de1ef40f4b10
197805ibuprofen 400 MG Oral TabletSCD60f1c099-5fb5-47e8-b228-11de1ef40f4b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0690-17133506900120 TABLET, FILM COATED in 1 BOTTLE (71335-0690-1) 2019-02-010000-00-00NoNoCurrent
71335-0690-27133506900230 TABLET, FILM COATED in 1 BOTTLE (71335-0690-2) 2018-02-190000-00-00NoNoCurrent
71335-0690-37133506900340 TABLET, FILM COATED in 1 BOTTLE (71335-0690-3) 2018-02-270000-00-00NoNoCurrent
71335-0690-47133506900460 TABLET, FILM COATED in 1 BOTTLE (71335-0690-4) 2018-02-260000-00-00NoNoCurrent
71335-0690-57133506900590 TABLET, FILM COATED in 1 BOTTLE (71335-0690-5) 2018-07-260000-00-00NoNoCurrent
71335-0690-671335069006120 TABLET, FILM COATED in 1 BOTTLE (71335-0690-6) 2018-04-050000-00-00NoNoCurrent
71335-0690-771335069007100 TABLET, FILM COATED in 1 BOTTLE (71335-0690-7) 2021-12-270000-00-00NoNoCurrent
71335-0690-87133506900821 TABLET, FILM COATED in 1 BOTTLE (71335-0690-8) 2018-08-210000-00-00NoNoCurrent
71335-0690-97133506900915 TABLET, FILM COATED in 1 BOTTLE (71335-0690-9) 2018-02-200000-00-00NoNoCurrent