FDA.reportPublic FDA data

Ibuprofen

Product NDC
70518-2432
11-digit product format
705182432
Labeler code
70518
Product ID
70518-2432_4a1915ed-5cbd-a74a-e063-6394a90a8283
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090796
Marketing category
ANDA
Marketing start
2019-11-18
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2432-02023-03-09C16284748780-1f386c64a-11b9-0266-e053-dadaa90a7c1aIBUPROFEN 400 MG, 600 MG AND 800 MG TABLETS
70518-2432-12023-03-09C16284748780-1f386c64a-11b9-0266-e053-dadaa90a7c1aIBUPROFEN 400 MG, 600 MG AND 800 MG TABLETS
70518-2432-02023-01-30C16284748780-1f386c64a-11b9-0266-e053-dadaa90a7c1aIBUPROFEN 400 MG, 600 MG AND 800 MG TABLETS
70518-2432-12023-01-30C16284748780-1f386c64a-11b9-0266-e053-dadaa90a7c1aIBUPROFEN 400 MG, 600 MG AND 800 MG TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2432-0Ibuprofen21 in 1 BLISTER PACKTABLET, FILM COATED219
70518-2432-1Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2432IBUPROFEN TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250316_a7756b22-73cf-4262-aa8e-0577ddecd03b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNa7756b22-73cf-4262-aa8e-0577ddecd03b9
197805ibuprofen 400 MG Oral TabletSCDa7756b22-73cf-4262-aa8e-0577ddecd03b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2432-07051824320021 TABLET, FILM COATED in 1 BLISTER PACK (70518-2432-0) 2019-11-180000-00-00NoNoCurrent
70518-2432-17051824320130 TABLET, FILM COATED in 1 BLISTER PACK (70518-2432-1) 2021-05-260000-00-00NoNoCurrent