FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-5446
11-digit product format
500905446
Labeler code
50090
Product ID
50090-5446_3d7a2f69-acb6-4040-9cd4-519fa5a20067
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5446-0Ibuprofen10 in 1 BOTTLETABLET1016
50090-5446-1Ibuprofen15 in 1 BOTTLETABLET1516
50090-5446-2Ibuprofen30 in 1 BOTTLETABLET3016
50090-5446-3Ibuprofen45 in 1 BOTTLETABLET4516
50090-5446-4Ibuprofen60 in 1 BOTTLETABLET6016
50090-5446-5Ibuprofen100 in 1 BOTTLETABLET10016
50090-5446-7Ibuprofen21 in 1 BOTTLETABLET2116
50090-5446-8Ibuprofen12 in 1 BOTTLETABLET1216
50090-5446-9Ibuprofen40 in 1 BOTTLETABLET4016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5446-0EA - Each50090-5446a7773238-2ab2-4e57-85c6-16d42422f1ad12024-06-10
50090-5446-1EA - Each50090-54464699bffd-8c17-4951-be12-b4ba0864e33812024-06-10
50090-5446-2EA - Each50090-5446c25a556a-f3a7-4a87-ade9-73e78cda68fb12024-03-12
50090-5446-3EA - Each50090-544674836018-6b93-4a5a-947a-c6b3124d14c512024-06-10
50090-5446-4EA - Each50090-544691ee36be-422f-49d7-8993-b7989628de5412024-06-10
50090-5446-5EA - Each50090-5446e1f5a3f9-e4c8-4dd9-b8a1-20ce58a008c412024-06-10
50090-5446-7EA - Each50090-5446cf2dffee-09ea-4c41-ab6f-eb460525c6eb12024-06-10
50090-5446-8EA - Each50090-544607fff2af-f163-43d0-b9dc-505bdb000daf12024-06-10
50090-5446-9EA - Each50090-54469fcf22a4-f0cb-40c7-b9c6-a45b13f2026612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5446IBUPROFEN TABLET [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 9 package rows20240530_f24582be-8d70-4848-bd54-e55fa28f394f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNf24582be-8d70-4848-bd54-e55fa28f394f16
197807ibuprofen 800 MG Oral TabletSCDf24582be-8d70-4848-bd54-e55fa28f394f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5446-05009054460010 TABLET in 1 BOTTLE (50090-5446-0) 10 tablet2021-01-220000-00-00NoNoCurrent
50090-5446-15009054460115 in 1 BOTTLEHistorical
50090-5446-25009054460230 TABLET in 1 BOTTLE (50090-5446-2) 30 tablet2021-01-220000-00-00NoNoCurrent
50090-5446-35009054460345 TABLET in 1 BOTTLE (50090-5446-3) 45 tablet2024-05-17NoNoHistorical
50090-5446-45009054460460 TABLET in 1 BOTTLE (50090-5446-4) 60 tablet2021-01-220000-00-00NoNoCurrent
50090-5446-550090544605100 TABLET in 1 BOTTLE (50090-5446-5) 100 tablet2021-01-220000-00-00NoNoCurrent
50090-5446-75009054460721 TABLET in 1 BOTTLE (50090-5446-7) 21 tablet2021-01-220000-00-00NoNoCurrent
50090-5446-85009054460812 TABLET in 1 BOTTLE (50090-5446-8) 12 tablet2021-01-220000-00-00NoNoCurrent
50090-5446-95009054460940 TABLET in 1 BOTTLE (50090-5446-9) 40 tablet2021-01-220000-00-00NoNoCurrent