FDA.reportPublic FDA data

Ibuprofen

Product NDC
62207-365
11-digit product format
622070365
Labeler code
62207
Product ID
62207-365_f37b04a6-8c5f-0644-e053-2995a90a40a0
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Limited
Application
ANDA079174
Marketing category
ANDA
Marketing start
2011-01-01
Substance
IBUPROFEN
Active strength
200 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

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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct62207-365UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-16UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-24UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-25UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-26UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-27UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-66UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-67UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-68UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage62207-36562207-365-80UNFINISHEDActive or certified unfinished drug listing2026-07-31

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
A079174-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2010-12-10

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 22:54:322026-06A079174-001IBUPROFEN200MGTABLET / ORAL2010-12-10a50c72e98297…

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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENTWIN MED LLCf03958f8-aeae-edf0-e053-2a95a90a3e9e2026-07-22WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Ibuwin ForteIBUPROFENOPMX LLC0daf1be9-ea38-461e-e063-6394a90a79542026-07-15WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENDr. Reddy's Laboratories Inc.4d830b9b-b396-9581-7572-c7f19ff175972026-07-01WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.68988a5b-7a6a-4ecd-8006-f2610bac2ad72026-06-08WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENMedline industries, LP5d2482b4-cd90-4246-85a9-fd1d35315b6c2026-06-04WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENGrocery Outlet, Inc.441d762d-9022-426a-e063-6294a90a50762026-05-21WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IBUPROFEN 200 MGIBUPROFEN 200 MGFarmacias De Similares TX LLC441f7920-5666-5a3e-e063-6294a90a55832026-01-28WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENHYVEE INC45aead8a-37ee-9a66-e063-6394a90a5d172026-01-13WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Xpect IbuprofenIBUPROFENCintas Corporation976ba88a-6428-40d1-a2fd-eac64963ba1d2026-01-08WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
Lil Drug Store IbuprofenIBUPROFENLil Drug Store Products, Inc29190ebf-bb9c-4406-be7b-4427741aeb742025-12-23WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENCVS10424ad8-74fc-4f5f-e063-6394a90a13bd2025-12-23WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENGranules USA, Inc.8cb595d2-b7c2-687d-e053-2a95a90a57202025-12-22WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENRetail Business Services, LLC04115ec1-ef31-1746-e063-6394a90a0a522025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a567dc6f-bd83-b9f5-e053-2995a90a05ee2025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c17f-9766-deaa-e063-6394a90a8d602025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IBUPROFENIBUPROFENWALGREENS CO.b8a77b7e-e161-b3ac-e053-2995a90af3e82025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENFamily Dollarfe17f5a6-fd6d-d839-e053-6394a90a59a42025-12-19WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.8c3ca03e-0ec2-c15c-e053-2995a90ad8bd2025-12-18WarningsExact identifier
application applno (ANDA): 079174
application number: ANDA079174

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WK2XYI10QMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310965Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd01353d-1d1d-42b5-9a03-575052189bf5Available on FDA.report

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
62207-365-41Ibuprofen24 in 1 BOTTLETABLET2418
62207-365-42Ibuprofen50 in 1 BOTTLETABLET5018
62207-365-43Ibuprofen100 in 1 BOTTLETABLET10018
62207-365-46Ibuprofen250 in 1 BOTTLETABLET25018
62207-365-47Ibuprofen500 in 1 BOTTLETABLET50018
62207-365-48Ibuprofen750 in 1 BOTTLETABLET75018
62207-365-49Ibuprofen1000 in 1 BOTTLETABLET100018
62207-365-51Ibuprofen10 in 1 BOTTLETABLET1018

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN TABLET [GRANULES INDIA LIMITED]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [GRANULES INDIA LIMITED]11
TRIACETININACTIVE INGREDIENTXHX3C3X673IBUPROFEN TABLET [GRANULES INDIA LIMITED]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-365IBUPROFEN TABLET [GRANULES INDIA LIMITED]18Current NDC, Legacy NDC, 8 package rows20230131_fd01353d-1d1d-42b5-9a03-575052189bf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNfd01353d-1d1d-42b5-9a03-575052189bf518
310965ibuprofen 200 MG Oral TabletSCDfd01353d-1d1d-42b5-9a03-575052189bf518
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYfd01353d-1d1d-42b5-9a03-575052189bf518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-365-1662207036516258899 TABLET in 1 DRUM (62207-365-16)258899 tablet10-NOV-19Current
62207-365-246220703652448000 TABLET in 1 BOX (62207-365-24)48000 tablet01-JAN-11Current
62207-365-256220703652571000 TABLET in 1 BOX (62207-365-25)71000 tablet01-JAN-11Current
62207-365-266220703652680000 TABLET in 1 BOX (62207-365-26)80000 tablet01-JAN-11Current
62207-365-276220703652797000 TABLET in 1 BOX (62207-365-27)97000 tablet01-JAN-11Current
62207-365-416220703654124 TABLET in 1 BOTTLE (62207-365-41) 24 tablet2019-08-130000-00-00NoNoCurrent
62207-365-426220703654250 TABLET in 1 BOTTLE (62207-365-42) 50 tablet2019-08-130000-00-00NoNoCurrent
62207-365-4362207036543100 TABLET in 1 BOTTLE (62207-365-43) 100 tablet2019-08-130000-00-00NoNoCurrent
62207-365-4662207036546250 TABLET in 1 BOTTLE (62207-365-46) 250 tablet2019-08-130000-00-00NoNoCurrent
62207-365-4762207036547500 TABLET in 1 BOTTLE (62207-365-47) 500 tablet2019-08-130000-00-00NoNoCurrent
62207-365-4862207036548750 TABLET in 1 BOTTLE (62207-365-48) 750 tablet2019-08-130000-00-00NoNoCurrent
62207-365-49622070365491000 TABLET in 1 BOTTLE (62207-365-49) 1000 tablet2019-08-130000-00-00NoNoCurrent
62207-365-516220703655110 TABLET in 1 BOTTLE (62207-365-51) 10 tablet2019-08-130000-00-00NoNoCurrent
62207-365-6662207036566258000 TABLET in 1 DRUM (62207-365-66)258000 tablet01-JAN-11Current
62207-365-6762207036567190476 TABLET in 1 DRUM (62207-365-67)190476 tablet01-JAN-11Current
62207-365-6862207036568175000 TABLET in 1 BOX (62207-365-68)175000 tablet01-JAN-11Current
62207-365-8062207036580258000 TABLET in 1 DRUM (62207-365-80)258000 tablet01-JAN-11Current