FDA.reportPublic FDA data

Ibuprofen

Product NDC
71335-1218
11-digit product format
713351218
Labeler code
71335
Product ID
71335-1218_3018301b-f363-483b-bd7f-842bae77e2e7
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
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
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
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
71335-1218-0Ibuprofen21 in 1 BOTTLETABLET, FILM COATED21103
71335-1218-1Ibuprofen20 in 1 BOTTLETABLET, FILM COATED20103
71335-1218-2Ibuprofen15 in 1 BOTTLETABLET, FILM COATED15103
71335-1218-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED30103
71335-1218-4Ibuprofen40 in 1 BOTTLETABLET, FILM COATED40103
71335-1218-5Ibuprofen60 in 1 BOTTLETABLET, FILM COATED60103
71335-1218-6Ibuprofen90 in 1 BOTTLETABLET, FILM COATED90103
71335-1218-7Ibuprofen120 in 1 BOTTLETABLET, FILM COATED120103
71335-1218-8Ibuprofen50 in 1 BOTTLETABLET, FILM COATED50103
71335-1218-9Ibuprofen100 in 1 BOTTLETABLET, FILM COATED100103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1218-0EA - Each71335-12184c78ce70-88d9-481b-8922-fee8868055d312021-11-09
71335-1218-1EA - Each71335-1218b7a3e5c5-4c40-49fd-981a-ad481b7e761912021-11-09
71335-1218-2EA - Each71335-1218c220dc31-1ae9-47a1-b39a-ae5ac70a7d7b12021-11-09
71335-1218-3EA - Each71335-1218b89510f4-9210-4b45-9f2a-8905f51f699812019-10-07
71335-1218-4EA - Each71335-1218a5b863a2-aee6-4150-b571-35669b22ecb712021-11-09
71335-1218-5EA - Each71335-1218938d470d-329c-4f65-af5c-0f7623070e8312021-11-09
71335-1218-6EA - Each71335-1218431cdead-f181-43b5-afbe-20ec0386b3dc12021-11-09
71335-1218-7EA - Each71335-1218f7594538-37c0-470f-9584-fb632244680d12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1218IBUPROFEN TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240809_ffc953f7-ed92-4528-bb2f-72c634c119fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNffc953f7-ed92-4528-bb2f-72c634c119fa103
197806ibuprofen 600 MG Oral TabletSCDffc953f7-ed92-4528-bb2f-72c634c119fa103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1218-07133512180021 TABLET, FILM COATED in 1 BOTTLE (71335-1218-0) 2022-02-090000-00-00NoNoCurrent
71335-1218-17133512180120 TABLET, FILM COATED in 1 BOTTLE (71335-1218-1) 2022-02-090000-00-00NoNoCurrent
71335-1218-27133512180215 TABLET, FILM COATED in 1 BOTTLE (71335-1218-2) 2022-02-090000-00-00NoNoCurrent
71335-1218-37133512180330 TABLET, FILM COATED in 1 BOTTLE (71335-1218-3) 2022-02-090000-00-00NoNoCurrent
71335-1218-47133512180440 TABLET, FILM COATED in 1 BOTTLE (71335-1218-4) 2022-02-090000-00-00NoNoCurrent
71335-1218-57133512180560 TABLET, FILM COATED in 1 BOTTLE (71335-1218-5) 2022-02-090000-00-00NoNoCurrent
71335-1218-67133512180690 TABLET, FILM COATED in 1 BOTTLE (71335-1218-6) 2022-02-090000-00-00NoNoCurrent
71335-1218-771335121807120 TABLET, FILM COATED in 1 BOTTLE (71335-1218-7) 2022-02-090000-00-00NoNoCurrent
71335-1218-87133512180850 TABLET, FILM COATED in 1 BOTTLE (71335-1218-8) 2022-02-090000-00-00NoNoCurrent
71335-1218-971335121809100 TABLET, FILM COATED in 1 BOTTLE (71335-1218-9) 2022-02-090000-00-00NoNoCurrent