FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-5433
11-digit product format
500905433
Labeler code
50090
Product ID
50090-5433_31988d3c-1f44-4f32-b838-1a54b3d1af9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213794
Marketing category
ANDA
Marketing start
2020-05-08
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
50090-5433-12025-07-18C16284748780-11030e365-4f1e-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP Rx only
50090-5433-42025-07-18C16284748780-11030e365-4f1e-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP Rx only
50090-5433-52025-07-18C16284748780-11030e365-4f1e-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP Rx only
50090-5433-12024-01-30C16284748780-11030e365-4f1e-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP Rx only
50090-5433-42024-01-30C16284748780-11030e365-4f1e-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP Rx only
50090-5433-52024-01-30C16284748780-11030e365-4f1e-111a-e063-dadaa90a10e2Ibuprofen Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5433-0Ibuprofen15 in 1 BOTTLETABLET1514
50090-5433-1Ibuprofen21 in 1 BOTTLETABLET2114
50090-5433-4Ibuprofen28 in 1 BOTTLETABLET2814
50090-5433-5Ibuprofen90 in 1 BOTTLETABLET9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5433-0EA - Each50090-54331c140522-20bd-48f5-9973-8373ae53130d12025-08-11
50090-5433-1EA - Each50090-5433b13add54-67d5-40c3-8f92-6e1ed5a091ea12025-08-11
50090-5433-4EA - Each50090-54332feb39aa-fa85-434e-8a0a-2c3c96283c4412025-08-11
50090-5433-5EA - Each50090-5433c97541ec-4fc3-49bb-a355-eedd83f9330f12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5433IBUPROFEN TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 4 package rows20220709_8d5f7d2a-af48-4d47-8bf5-48f01c092d24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN8d5f7d2a-af48-4d47-8bf5-48f01c092d2414
197806ibuprofen 600 MG Oral TabletSCD8d5f7d2a-af48-4d47-8bf5-48f01c092d2414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5433-05009054330015 TABLET in 1 BOTTLE (50090-5433-0) 15 tablet2025-07-17NoNoHistorical
50090-5433-15009054330121 TABLET in 1 BOTTLE (50090-5433-1) 21 tablet2021-01-180000-00-00NoNoCurrent
50090-5433-45009054330428 TABLET in 1 BOTTLE (50090-5433-4) 28 tablet2021-01-180000-00-00NoNoCurrent
50090-5433-55009054330590 TABLET in 1 BOTTLE (50090-5433-5) 90 tablet2021-01-180000-00-00NoNoCurrent