FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-5444
11-digit product format
500905444
Labeler code
50090
Product ID
50090-5444_cb8e6344-17f1-4426-a2fd-64e652fad6f2
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
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5444-52024-01-02C16284748780-1f386c64a-1fdc-0266-e053-dadaa90a7c1aIbuprofen Tablets, USP Rx only
50090-5444-72024-01-02C16284748780-1f386c64a-1fdc-0266-e053-dadaa90a7c1aIbuprofen Tablets, USP Rx only
50090-5444-52023-01-30C16284748780-1f386c64a-1fdc-0266-e053-dadaa90a7c1aIbuprofen Tablets, USP Rx only
50090-5444-72023-01-30C16284748780-1f386c64a-1fdc-0266-e053-dadaa90a7c1aIbuprofen Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5444-4Ibuprofen28 in 1 BOTTLETABLET287
50090-5444-5Ibuprofen90 in 1 BOTTLETABLET907
50090-5444-7Ibuprofen20 in 1 BOTTLETABLET207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5444-5EA - Each50090-54445dd56a10-740c-403d-860e-74990f39ae5c12024-06-10
50090-5444-7EA - Each50090-54446bf956a7-cdad-4350-8831-ec4a0440eaa912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5444IBUPROFEN TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20240102_3db0c659-cc43-45dc-8442-bc89093d94d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN3db0c659-cc43-45dc-8442-bc89093d94d77
197807ibuprofen 800 MG Oral TabletSCD3db0c659-cc43-45dc-8442-bc89093d94d77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5444-45009054440428 TABLET in 1 BOTTLE (50090-5444-4) 28 tablet2021-01-22NoNoHistorical
50090-5444-55009054440590 TABLET in 1 BOTTLE (50090-5444-5) 90 tablet2021-01-220000-00-00NoNoCurrent
50090-5444-75009054440720 TABLET in 1 BOTTLE (50090-5444-7) 20 tablet2021-01-220000-00-00NoNoCurrent