FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-2626
11-digit product format
500902626
Labeler code
50090
Product ID
50090-2626_fe30b744-75e5-48b0-baa6-40ed03947d77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2626-02023-02-07C16284748780-1f386c649-d560-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2626-12023-02-07C16284748780-1f386c649-d560-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2626-42023-02-07C16284748780-1f386c649-d560-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2626-52023-02-07C16284748780-1f386c649-d560-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2626-02023-01-30C16284748780-1f386c649-d560-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2626-12023-01-30C16284748780-1f386c649-d560-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2626-42023-01-30C16284748780-1f386c649-d560-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP
50090-2626-52023-01-30C16284748780-1f386c649-d560-0266-e053-dadaa90a7c1aIBUPROFEN Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2626-0Ibuprofen15 in 1 BOTTLETABLET, FILM COATED1530
50090-2626-1Ibuprofen21 in 1 BOTTLETABLET, FILM COATED2130
50090-2626-4Ibuprofen28 in 1 BOTTLETABLET, FILM COATED2830
50090-2626-5Ibuprofen90 in 1 BOTTLETABLET, FILM COATED9030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2626-0EA - Each50090-262637aeb238-34e5-4caa-ba70-12c3c94d506a12019-04-11
50090-2626-1EA - Each50090-2626413a6daa-5ae7-4dc9-9bfd-e88fdf5e1ef312019-04-11
50090-2626-4EA - Each50090-26268134b347-eaad-47da-98e0-c747c488eb3412019-04-11
50090-2626-5EA - Each50090-262681ea969c-c566-44d3-bc90-475c3bd920c412018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2626IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]30Current NDC, Legacy NDC, 4 package rows20250510_b40f39e4-a37c-4039-ae37-210c1c3c6235.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNb40f39e4-a37c-4039-ae37-210c1c3c623530
197806ibuprofen 600 MG Oral TabletSCDb40f39e4-a37c-4039-ae37-210c1c3c623530

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2626-05009026260015 TABLET, FILM COATED in 1 BOTTLE (50090-2626-0) 2017-06-120000-00-00NoNoCurrent
50090-2626-15009026260121 TABLET, FILM COATED in 1 BOTTLE (50090-2626-1) 2016-12-140000-00-00NoNoCurrent
50090-2626-45009026260428 TABLET, FILM COATED in 1 BOTTLE (50090-2626-4) 2017-01-200000-00-00NoNoCurrent
50090-2626-55009026260590 TABLET, FILM COATED in 1 BOTTLE (50090-2626-5) 2016-11-170000-00-00NoNoCurrent