FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-2549
11-digit product format
500902549
Labeler code
50090
Product ID
50090-2549_ecdc36b7-da4b-4d39-a9e0-6d8b24cc549b
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2549-0Ibuprofen4 in 1 BOTTLETABLET, FILM COATED441
50090-2549-4Ibuprofen28 in 1 BOTTLETABLET, FILM COATED2841
50090-2549-5Ibuprofen90 in 1 BOTTLETABLET, FILM COATED9041
50090-2549-7Ibuprofen20 in 1 BOTTLETABLET, FILM COATED2041

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2549-4EA - Each50090-25493a6c9f7f-09d3-47e1-a323-567b56f24f9812019-03-12
50090-2549-5EA - Each50090-2549582bbf37-504d-446c-b962-db01268c335412018-11-06
50090-2549-7EA - Each50090-254990b92dbe-9d49-46e0-afd9-d3a0c091575812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2549IBUPROFEN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]41Current NDC, Legacy NDC, 4 package rows20231211_8553e29a-7f6f-4ff8-9991-836e619c504d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN8553e29a-7f6f-4ff8-9991-836e619c504d41
197807ibuprofen 800 MG Oral TabletSCD8553e29a-7f6f-4ff8-9991-836e619c504d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2549-0500902549004 TABLET, FILM COATED in 1 BOTTLE (50090-2549-0) 2018-10-190000-00-00NoNoCurrent
50090-2549-45009025490428 TABLET, FILM COATED in 1 BOTTLE (50090-2549-4) 2016-11-070000-00-00NoNoCurrent
50090-2549-55009025490590 TABLET, FILM COATED in 1 BOTTLE (50090-2549-5) 2016-10-200000-00-00NoNoCurrent
50090-2549-75009025490720 TABLET, FILM COATED in 1 BOTTLE (50090-2549-7) 2016-10-200000-00-00NoNoCurrent