FDA.reportPublic FDA data

75907-331

Product NDC
75907-331
11-digit product format
759070331
Labeler code
75907
Product ID
75907-331_e23e9160-3a07-bdaf-a09e-283cc24f76c6
Type
DRUG FOR FURTHER PROCESSING
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Marketing category
DRUG FOR FURTHER PROCESSING
Marketing start
2025-09-26
Substance
IBUPROFEN
Active strength
400 mg/1
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct75907-331UNFINISHEDActive or certified unfinished drug listing2026-10-12
unfinished packagepackage75907-33175907-331-94UNFINISHEDActive or certified unfinished drug listing2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproduct75907-331UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipa6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage75907-33175907-331-94UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipa6255e0c9aa5…a0211a219f2e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
No
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN400 mg/1

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN3ff501eb-5ae3-8824-e063-6394a90ac58e3
197806ibuprofen 600 MG Oral TabletPSN3ff501eb-5ae3-8824-e063-6394a90ac58e3
197807ibuprofen 800 MG Oral TabletPSN3ff501eb-5ae3-8824-e063-6394a90ac58e3
197805ibuprofen 400 MG Oral TabletSCD3ff501eb-5ae3-8824-e063-6394a90ac58e3
197806ibuprofen 600 MG Oral TabletSCD3ff501eb-5ae3-8824-e063-6394a90ac58e3
197807ibuprofen 800 MG Oral TabletSCD3ff501eb-5ae3-8824-e063-6394a90ac58e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
75907-331-94759070331944000 TABLET in 1 POUCH (75907-331-94)4000 tablet26-SEP-25Current