FDA.reportPublic FDA data

Ibuprofen

Product NDC
70518-4010
11-digit product format
705184010
Labeler code
70518
Product ID
70518-4010_4c96b138-b5b8-3546-e063-6394a90adba0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213794
Marketing category
ANDA
Marketing start
2024-02-05
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4010-0Ibuprofen30 in 1 BLISTER PACKTABLET306
70518-4010-1Ibuprofen10 in 1 BLISTER PACKTABLET106
70518-4010-2Ibuprofen30 in 1 BLISTER PACKTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4010IBUPROFEN TABLET [REMEDYREPACK INC.]3Current NDC, 3 package rows20241207_2fa4bfc8-386c-433b-bc46-24fc8ec1bca1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN2fa4bfc8-386c-433b-bc46-24fc8ec1bca16
197807ibuprofen 800 MG Oral TabletSCD2fa4bfc8-386c-433b-bc46-24fc8ec1bca16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4010-07051840100030 TABLET in 1 BLISTER PACK (70518-4010-0) 30 tablet2024-02-05NoNoCurrent
70518-4010-17051840100110 in 1 BLISTER PACKHistorical
70518-4010-27051840100230 TABLET in 1 BLISTER PACK (70518-4010-2) 30 tablet2025-06-02NoNoCurrent