FDA.reportPublic FDA data

IBUPROFEN

Product NDC
62207-320
11-digit product format
622070320
Labeler code
62207
Product ID
62207-320_44a726e4-0a4b-b303-e063-6394a90a9073
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
Granules India Limited
Application
ANDA202312
Marketing category
ANDA
Marketing start
2019-11-14
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202312-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2016-10-07

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073f01610625f2…
2019-09-15 20:21 UTC2019-09A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202312-001IBUPROFEN200MGTABLET / ORAL2016-10-07e64feba35796…

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
97516b9f-219a-429d-850d-1fe9fd66646bAvailable 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
62207-320-41IBUPROFEN24 in 1 BOTTLETABLET246
62207-320-42IBUPROFEN50 in 1 BOTTLETABLET506
62207-320-43IBUPROFEN100 in 1 BOTTLETABLET1006
62207-320-46IBUPROFEN250 in 1 BOTTLETABLET2506
62207-320-47IBUPROFEN500 in 1 BOTTLETABLET5006
62207-320-48IBUPROFEN750 in 1 BOTTLETABLET7506
62207-320-49IBUPROFEN1000 in 1 BOTTLETABLET10006
62207-320-89IBUPROFEN10 in 1 BOTTLETABLET106
62207-320-90IBUPROFEN1700 in 1 BOTTLETABLET17006
62207-320-91IBUPROFEN160000 in 1 DRUMTABLET1600006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62207-320IBUPROFEN TABLET [GRANULES INDIA LIMITED]5Current NDC, Legacy NDC, 10 package rows20230131_97516b9f-219a-429d-850d-1fe9fd66646b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENShield Pharmaceuticals Corp22102461-0196-4ef0-aef4-66997d74d1182026-08-10WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENHarris Teeter637210f0-6494-4656-8b2b-14d7476cb1272026-07-29WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IBUPROFENIBUPROFENHarris Teeter14515409-736f-4119-b6a0-cb19ee2e948e2026-07-29WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IBUPROFENIBUPROFENGranules India Limited97516b9f-219a-429d-850d-1fe9fd66646b2026-06-15WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
ndc (product): 62207-320
IbuprofenIBUPROFENHYVEE INC459fc063-0664-09b7-e063-6394a90a89e02026-01-13WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENHYVEE INC459fc670-32a3-61a6-e063-6294a90aea5a2026-01-13WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a568fd1e-9bf0-3c03-e053-2a95a90a45b72025-12-19WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c85b-2ba5-32c3-e063-6294a90af1482025-12-19WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENWalgreens07edb8d0-2fa8-4b40-e063-6294a90a2fe92025-12-19WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.a3c1a61b-88fc-419c-e053-2a95a90ac0c32025-12-18WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYa42f96c4-322d-4714-9435-7b5a4e8b6ae52025-12-11WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY36b95840-f621-437a-bf49-406d320964da2025-12-11WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC9c1ded4e-1d3b-1ab6-e053-2995a90aa80d2025-12-10WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC9c1cc205-b9e3-03fc-e053-2995a90aaffb2025-12-10WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IBUPROFENIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f40f5-625d-3f2e-e053-2a95a90a438b2025-11-18WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES , LLC.8f9f42a7-c2d8-4a51-e053-2a95a90a16772025-11-18WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENDemoulas Super Markets, Inc39802e26-1028-d2fe-e063-6394a90a24c72025-07-16WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENMarc Glassman, Inc.9714e804-fadb-103d-e053-2a95a90ad7652025-07-15WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENMARC GLASSMAN, INC.9714de6b-068b-d6b9-e053-2995a90a3b272025-07-15WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312
IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFI8fecb3a8-d288-cacf-e053-2a95a90ae2382025-07-01WarningsExact identifier
application applno (ANDA): 202312
application number: ANDA202312

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN97516b9f-219a-429d-850d-1fe9fd66646b6
310965ibuprofen 200 MG Oral TabletSCD97516b9f-219a-429d-850d-1fe9fd66646b6
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY97516b9f-219a-429d-850d-1fe9fd66646b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62207-320-416220703204124 TABLET in 1 BOTTLE (62207-320-41) 24 tablet2019-11-140000-00-00NoNoCurrent
62207-320-426220703204250 TABLET in 1 BOTTLE (62207-320-42) 50 tablet2019-11-140000-00-00NoNoCurrent
62207-320-4362207032043100 TABLET in 1 BOTTLE (62207-320-43) 100 tablet2019-11-140000-00-00NoNoCurrent
62207-320-4662207032046250 TABLET in 1 BOTTLE (62207-320-46) 250 tablet2019-11-140000-00-00NoNoCurrent
62207-320-4762207032047500 TABLET in 1 BOTTLE (62207-320-47) 500 tablet2019-11-140000-00-00NoNoCurrent
62207-320-4862207032048750 TABLET in 1 BOTTLE (62207-320-48) 750 tablet2019-11-140000-00-00NoNoCurrent
62207-320-49622070320491000 TABLET in 1 BOTTLE (62207-320-49) 1000 tablet2019-11-140000-00-00NoNoCurrent
62207-320-896220703208910 TABLET in 1 BOTTLE (62207-320-89) 10 tablet2020-12-030000-00-00NoNoCurrent
62207-320-90622070320901700 TABLET in 1 BOTTLE (62207-320-90) 1700 tablet2020-12-030000-00-00NoNoCurrent
62207-320-9162207032091160000 TABLET in 1 DRUM (62207-320-91) 160000 tablet2019-11-140000-00-00NoNoCurrent