FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-5435
11-digit product format
500905435
Labeler code
50090
Product ID
50090-5435_faf5e083-7764-4a5e-8810-ecfa0ab69017
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5435-0Ibuprofen10 in 1 BOTTLETABLET1013
50090-5435-2Ibuprofen16 in 1 BOTTLETABLET1613
50090-5435-3Ibuprofen30 in 1 BOTTLETABLET3013
50090-5435-4Ibuprofen60 in 1 BOTTLETABLET6013
50090-5435-5Ibuprofen100 in 1 BOTTLETABLET10013
50090-5435-7Ibuprofen40 in 1 BOTTLETABLET4013
50090-5435-8Ibuprofen20 in 1 BOTTLETABLET2013
50090-5435-9Ibuprofen24 in 1 BOTTLETABLET2413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5435-0EA - Each50090-54352bdb24c3-def3-43de-9be3-cb4b6ac8207212025-08-11
50090-5435-2EA - Each50090-54358c6d16e4-eb10-4e02-af3f-7c79536adea712025-08-11
50090-5435-3EA - Each50090-5435780746bc-b3d5-49ea-b63f-38be32a23fa512022-12-07
50090-5435-4EA - Each50090-54354a49a3e9-d05b-4286-91e8-7b9061c3928012025-08-11
50090-5435-5EA - Each50090-5435c2671294-208d-44de-a335-87582c14306c12025-08-11
50090-5435-7EA - Each50090-5435c1dbf956-9fad-4514-823f-f16371628f3212025-08-11
50090-5435-8EA - Each50090-54357ec19e68-d66d-4384-9a73-805be1029c8f12025-08-11
50090-5435-9EA - Each50090-5435a461b6b5-a09b-492b-acc9-3c88e5cf0fb312025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN4b75bd6f-5455-4237-991c-eacc0fdcf70913
197806ibuprofen 600 MG Oral TabletSCD4b75bd6f-5455-4237-991c-eacc0fdcf70913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5435-05009054350010 TABLET in 1 BOTTLE (50090-5435-0) 10 tablet2021-01-180000-00-00NoNoCurrent
50090-5435-25009054350216 TABLET in 1 BOTTLE (50090-5435-2) 16 tablet2021-01-180000-00-00NoNoCurrent
50090-5435-35009054350330 TABLET in 1 BOTTLE (50090-5435-3) 30 tablet2021-01-180000-00-00NoNoCurrent
50090-5435-45009054350460 TABLET in 1 BOTTLE (50090-5435-4) 60 tablet2021-01-180000-00-00NoNoCurrent
50090-5435-550090543505100 TABLET in 1 BOTTLE (50090-5435-5) 100 tablet2021-01-180000-00-00NoNoCurrent
50090-5435-75009054350740 TABLET in 1 BOTTLE (50090-5435-7) 40 tablet2021-01-180000-00-00NoNoCurrent
50090-5435-85009054350820 TABLET in 1 BOTTLE (50090-5435-8) 20 tablet2021-01-180000-00-00NoNoCurrent
50090-5435-95009054350924 TABLET in 1 BOTTLE (50090-5435-9) 24 tablet2021-01-180000-00-00NoNoCurrent