FDA.reportPublic FDA data

Ibuprofen 200mg

Product NDC
69168-383
11-digit product format
691680383
Labeler code
69168
Product ID
69168-383_d06aa23d-6a79-4fcc-95fe-43977377cb6e
Type
HUMAN OTC DRUG
Nonproprietary name
383 Ibuprofen 200mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA091239
Marketing category
ANDA
Marketing start
2014-12-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69168-383DDiscontinued by firm2026-07-31
excluded packagepackage69168-38369168-383-01DDiscontinued by firm2026-07-31
excluded packagepackage69168-38369168-383-03DDiscontinued by firm2026-07-31
excluded packagepackage69168-38369168-383-05DDiscontinued by firm2026-07-31
excluded packagepackage69168-38369168-383-30DDiscontinued by firm2026-07-31
excluded packagepackage69168-38369168-383-40DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091239-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENGrocery Outlet, Inc.44660e1d-79c2-34ce-e063-6294a90ade3f2026-03-17WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENKroger Companybc173f1b-2e44-2c2e-e053-2a95a90a89c42025-09-24WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENTIME CAP LABORATORIES,INCf58d35f9-e44b-417b-98ce-0766b537cd2f2025-06-12WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENWALGREENS7653b33c-7489-10db-e053-2991aa0ab5082025-06-06WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
AeroTab IbuprofenIBUPROFEN TABLETAero Healthcareddd0f7fb-ae4b-c584-e053-2a95a90a09842025-02-26WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCa6d4ceb0-2b79-496a-aa1e-27edd507ced02024-12-10WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENSAM'S WEST INC16595d75-6e74-0839-e063-6394a90abc132024-05-28WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENWALGREENS746f79aa-3036-1b9b-e053-2a91aa0a1db62024-03-18WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFEN CAIBUPROFENTARGET CORPORATION8e8684fa-095e-c6d6-e053-2a95a90a15b42024-01-03WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENTARGET CORPORATION8e86ae68-7687-79d6-e053-2995a90ac2742024-01-03WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb613c44-e125-0f40-e053-2995a90a7ca52023-10-02WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb60e636-41fe-49fb-e053-2a95a90a06162023-09-29WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
ibuprofenIBUPROFENDOLGENCORP INC8f1358aa-495a-23da-e053-2995a90aa4302023-01-02WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENRITE AID CORPORATIONa7aa790a-6d6c-7929-e053-2995a90a1cf82022-01-04WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED3c8df1e5-61bc-4e70-b6b9-8973986ad5892021-12-21WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239
IBUPROFENIBUPROFENRITE AID CORPORATIONa7abac4c-7695-cfe8-e053-2a95a90ac1cd2021-10-30WarningsExact identifier
application applno (ANDA): 091239
application number: ANDA091239

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-383-01691680383011 BOTTLE in 1 CARTON (69168-383-01) > 100 TABLET in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent
69168-383-0369168038303250 TABLET in 1 BOTTLE (69168-383-03) 250 tablet2014-12-230000-00-00NoNoCurrent
69168-383-0569168038305500 TABLET in 1 BOTTLE (69168-383-05) 500 tablet2021-05-030000-00-00NoNoCurrent
69168-383-30691680383301 BOTTLE in 1 CARTON (69168-383-30) > 30 TABLET in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent
69168-383-40691680383401 BOTTLE in 1 CARTON (69168-383-40) > 40 TABLET in 1 BOTTLE1 bottle2014-12-230000-00-00NoNoCurrent