FDA.reportPublic FDA data

Ibuprofen

Product NDC
70518-1364
11-digit product format
705181364
Labeler code
70518
Product ID
70518-1364_510204b0-6bac-117c-e063-6294a90a1967
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091625
Marketing category
ANDA
Marketing start
2018-08-09
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
70518-1364-0Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022
70518-1364-1Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED3022
70518-1364-2Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2022
70518-1364-3Ibuprofen45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4522
70518-1364-4Ibuprofen27 in 1 BLISTER PACKTABLET, FILM COATED2722
70518-1364-5Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022
70518-1364-6Ibuprofen21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2122
70518-1364-7Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED3022
70518-1364-8Ibuprofen100 in 1 BOXTABLET, FILM COATED10022
70518-1364-9Ibuprofen1 in 1 POUCHTABLET, FILM COATED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1364IBUPROFEN TABLET, FILM COATED [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 10 package rows20250511_b6a6c940-daf6-4e0e-aefb-35cce87a9a55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNb6a6c940-daf6-4e0e-aefb-35cce87a9a5522
197806ibuprofen 600 MG Oral TabletSCDb6a6c940-daf6-4e0e-aefb-35cce87a9a5522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1364-07051813640030 in 1 BOTTLE, PLASTICHistorical
70518-1364-17051813640130 TABLET, FILM COATED in 1 BLISTER PACK (70518-1364-1) 2019-09-030000-00-00NoNoCurrent
70518-1364-27051813640220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1364-2) 2020-10-23NoNoHistorical
70518-1364-37051813640345 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1364-3) 2022-07-260000-00-00NoNoCurrent
70518-1364-47051813640427 TABLET, FILM COATED in 1 BLISTER PACK (70518-1364-4) 2023-07-30NoNoHistorical
70518-1364-57051813640530 in 1 BOTTLE, PLASTICHistorical
70518-1364-67051813640621 in 1 BOTTLE, PLASTICHistorical
70518-1364-77051813640730 in 1 BLISTER PACKHistorical
70518-1364-870518136408100 POUCH in 1 BOX (70518-1364-8) / 1 TABLET, FILM COATED in 1 POUCH (70518-1364-9) 100 pouch2025-12-05NoNoHistorical
70518-1364-9705181364091 in 1 POUCHHistorical