FDA.reportPublic FDA data

Ibuprofen

Product NDC
50090-7789
11-digit product format
500907789
Labeler code
50090
Product ID
50090-7789_621a94e3-872b-4a93-9153-59b23ee88d83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-05-23
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
50090-7789-0Ibuprofen16 in 1 BOTTLETABLET, FILM COATED161
50090-7789-1Ibuprofen30 in 1 BOTTLETABLET, FILM COATED301
50090-7789-3Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1001
50090-7789-4Ibuprofen20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7789-0EA - Each50090-778919b04a0e-04e6-4f6c-9b3f-d53d246e0b9a12026-01-08
50090-7789-1EA - Each50090-77890cd49112-ed4f-443f-955d-26340a4af1bc12026-01-08
50090-7789-3EA - Each50090-7789e71a57a6-3a2a-4ac2-837e-44853314b76612026-01-08
50090-7789-4EA - Each50090-77894665aed3-2bd9-4785-a987-f1e7d90279a112026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN47711610-6577-4805-a2ce-cf9b7cbfa8121
197805ibuprofen 400 MG Oral TabletSCD47711610-6577-4805-a2ce-cf9b7cbfa8121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7789-05009077890016 TABLET, FILM COATED in 1 BOTTLE (50090-7789-0) 2025-11-24NoNoHistorical
50090-7789-15009077890130 TABLET, FILM COATED in 1 BOTTLE (50090-7789-1) 2025-11-24NoNoHistorical
50090-7789-350090778903100 TABLET, FILM COATED in 1 BOTTLE (50090-7789-3) 2025-11-24NoNoHistorical
50090-7789-45009077890420 TABLET, FILM COATED in 1 BOTTLE (50090-7789-4) 2025-11-24NoNoHistorical