FDA.reportPublic FDA data

Ibuprofen

Product NDC
70518-4259
11-digit product format
705184259
Labeler code
70518
Product ID
70518-4259_4ffd8acb-c9fb-2c13-e063-6394a90a35b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2025-01-22
Substance
IBUPROFEN
Active strength
800 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
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

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
70518-4259-0Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
70518-4259-1Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED304
70518-4259-2Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4259IBUPROFEN TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 3 package rows20250123_404df13d-4ada-4324-9eed-e21f5d5043a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN404df13d-4ada-4324-9eed-e21f5d5043a44
197807ibuprofen 800 MG Oral TabletSCD404df13d-4ada-4324-9eed-e21f5d5043a44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4259-07051842590030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4259-0) 2025-01-22NoNoCurrent
70518-4259-17051842590130 in 1 BLISTER PACKHistorical
70518-4259-27051842590260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4259-2) 2026-04-17NoNoCurrent