FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-5818
11-digit product format
500905818
Labeler code
50090
Product ID
50090-5818_4a0aea0e-7d7f-4a3c-82d1-cca96ef6bd6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078329
Marketing category
ANDA
Marketing start
2018-08-24
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
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
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
50090-5818-02023-02-07C16284748780-1f386c649-e2d5-0266-e053-dadaa90a7c1aIbuprofen tablets
50090-5818-22023-02-07C16284748780-1f386c649-e2d5-0266-e053-dadaa90a7c1aIbuprofen tablets
50090-5818-02023-01-30C16284748780-1f386c649-e2d5-0266-e053-dadaa90a7c1aIbuprofen tablets
50090-5818-22023-01-30C16284748780-1f386c649-e2d5-0266-e053-dadaa90a7c1aIbuprofen tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5818-0Ibuprofen90 in 1 BOTTLETABLET, FILM COATED905
50090-5818-2Ibuprofen28 in 1 BOTTLETABLET, FILM COATED285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5818-0EA - Each50090-58189e62b79e-2f7b-4da4-996d-648c9b78994912022-07-06
50090-5818-2EA - Each50090-581893792009-9520-4d18-bd4e-ce4e8b3e5eb512022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5818IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231125_7152b6ce-6113-4003-bf80-aa263be69392.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN7152b6ce-6113-4003-bf80-aa263be693925
197805ibuprofen 400 MG Oral TabletSCD7152b6ce-6113-4003-bf80-aa263be693925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5818-05009058180090 TABLET, FILM COATED in 1 BOTTLE (50090-5818-0) 2021-10-190000-00-00NoNoCurrent
50090-5818-25009058180228 TABLET, FILM COATED in 1 BOTTLE (50090-5818-2) 2021-10-190000-00-00NoNoCurrent