FDA.reportPublic FDA data

Ibuprofen

Product NDC
16103-396
Requested package NDC
16103-396-04
11-digit product format
161030396
Labeler code
16103
Product ID
16103-396_b930519b-3c6f-4f19-8e84-227c44b06331
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
ANDA091239
Marketing category
ANDA
Marketing start
2016-03-01
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16103-39616103-396-04IInactivated by FDA2026-08-03

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16103-396-042022-01-28C16284748780-1d6a99b39-4ed2-a426-e053-dadaa90af4c2Drug Facts
16103-396-062022-01-28C16284748780-1d6a99b39-4ed2-a426-e053-dadaa90af4c2Drug Facts
16103-396-082022-01-28C16284748780-1d6a99b39-4ed2-a426-e053-dadaa90af4c2Drug Facts
16103-396-112022-01-28C16284748780-1d6a99b39-4ed2-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-396-04Ibuprofen1 in 1 CARTONTABLET11
16103-396-04Ibuprofen30 in 1 BOTTLE, PLASTICTABLET301
16103-396-06Ibuprofen1 in 1 CARTONTABLET11
16103-396-06Ibuprofen50 in 1 BOTTLE, PLASTICTABLET501
16103-396-08Ibuprofen1 in 1 CARTONTABLET11
16103-396-08Ibuprofen100 in 1 BOTTLE, PLASTICTABLET1001
16103-396-11Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-396IBUPROFEN TABLET [PHARBEST PHARMACEUTICALS, INC.]1Legacy NDC, 7 package rows20180520_5ebcd4d3-0397-4061-be0f-7e50b9d1780d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN5ebcd4d3-0397-4061-be0f-7e50b9d1780d1
310965ibuprofen 200 MG Oral TabletPSN994cb67c-d77d-4319-a4ee-6c4d239ce6c31
310965ibuprofen 200 MG Oral TabletPSNb933a883-713b-47f0-9666-841359c661981
310965ibuprofen 200 MG Oral TabletSCD5ebcd4d3-0397-4061-be0f-7e50b9d1780d1
310965ibuprofen 200 MG Oral TabletSCD994cb67c-d77d-4319-a4ee-6c4d239ce6c31
310965ibuprofen 200 MG Oral TabletSCDb933a883-713b-47f0-9666-841359c661981
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5ebcd4d3-0397-4061-be0f-7e50b9d1780d1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY994cb67c-d77d-4319-a4ee-6c4d239ce6c31
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYb933a883-713b-47f0-9666-841359c661981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-396-04161030396041 BOTTLE, PLASTIC in 1 CARTON (16103-396-04) > 30 TABLET in 1 BOTTLE, PLASTIC2016-03-010000-00-00NoNoCurrent