Ibuprofen

Product NDC
50844-291
11-digit product format
508440291
Labeler code
50844
Product ID
50844-291_beb6ea94-7f3d-4d13-90a5-e717aa719050
Type
HUMAN OTC DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
L.N.K. International, Inc.
Application
ANDA075010
Marketing category
ANDA
Marketing start
1988-05-24
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 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
A075010-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1999-03-01

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013f01610625f2…
2019-09-15 20:21 UTC2019-09A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01cb3db0bc1861…

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
57b39311-bc20-ace6-75a9-a07a9311b373Available 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
50844-291-01Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-01Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
50844-291-02Ibuprofen12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1221
50844-291-02Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-03Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1021
50844-291-08Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2421
50844-291-08Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-10Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-10Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4021
50844-291-11Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6021
50844-291-11Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-12Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-12Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10021
50844-291-13Ibuprofen250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25021
50844-291-13Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-14Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50021
50844-291-15Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5021
50844-291-15Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-16Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100021
50844-291-17Ibuprofen300 in 1 BOTTLE, PLASTICTABLET, FILM COATED30021
50844-291-24Ibuprofen2 in 1 POUCHTABLET, FILM COATED221
50844-291-29Ibuprofen150 in 1 BOTTLE, PLASTICTABLET, FILM COATED15021
50844-291-29Ibuprofen1 in 1 CARTONTABLET, FILM COATED121
50844-291-50Ibuprofen50 in 1 CARTONTABLET, FILM COATED5021
50844-291-99Ibuprofen250 in 1 BOTTLE, PLASTICTABLET, FILM COATED25021

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50844-291IBUPROFEN TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]20Current NDC, Legacy NDC, 25 package rows20240628_57b39311-bc20-ace6-75a9-a07a9311b373.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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENTopco Associates, LLC59a88ca7-eb37-46de-9134-a5a6d330bd492026-06-23WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENL.N.K. International, Inc.57b39311-bc20-ace6-75a9-a07a9311b3732026-06-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
ndc (product): 50844-291
IbuprofenIBUPROFENRite Aid Corporationd9e698f3-c450-4eaa-9cfd-6f48c26560812026-06-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE718a4b73-5f46-4676-afda-f0b4819f58622026-06-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENWal-Mart Stores Inccb897d65-7e98-4d02-be64-0704416a0f292026-05-28WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENSalado Sales, Inc.06bc4445-5c80-4dd3-b1bb-d9244f45f5702026-05-20WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENH E B4805977f-a30b-4f86-9ef5-e66ad6b8bd532026-05-06WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE4a0c744f-4ad8-445e-bab1-7ffee35bf8612026-05-06WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Medique at Home IprinIBUPROFENSportpharm LLC954d0436-b681-4bf5-80ec-0de9ddcab9942026-04-24WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENCOSTCO WHOLESALE CORPORATIONa50abf26-d6e5-10e4-ea90-a40b96a887e52026-04-13WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENDiscount Drug Martcffad7af-44f5-4e54-9e46-c3c5d4ca182f2026-04-08WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENLidl US LLCb840e98e-be1b-496f-9f0d-3a1a55eb9fe42026-04-08WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENL.N.K. International, Inc.0ef4913b-5dc3-45bc-9cef-58601f8d2a792026-04-07WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENWalgreen Company86818ad6-fd45-4635-9ce8-eac986f008aa2026-03-11WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENDiscount Drug Martd0ebf2a7-551b-4acd-be60-2d0b936dd7032026-03-11WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Pain Relief IbuprofenIBUPROFENRite Aid Corporationc85c3d1f-7639-4cfa-bf3a-424b61757b1a2026-02-03WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENCVS Pharmacy8d9f11a5-ca98-4280-9c6a-093d32e60ace2026-01-22WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENL.N.K. International, Inc.d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c2026-01-12WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENMeijer Distribution Incc0c64ba5-b6b0-4221-9e44-110d92c937822026-01-12WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENDOLGENCORP, LLC37ccb303-c70e-48b3-a8a3-2b0097cf8f882026-01-05WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN57b39311-bc20-ace6-75a9-a07a9311b37321
310965ibuprofen 200 MG Oral TabletSCD57b39311-bc20-ace6-75a9-a07a9311b37321
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY57b39311-bc20-ace6-75a9-a07a9311b37321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50844-291-01508440291011 BOTTLE, PLASTIC in 1 CARTON (50844-291-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-02508440291021 BOTTLE, PLASTIC in 1 CARTON (50844-291-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-035084402910310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-03) 1988-05-240000-00-00NoNoCurrent
50844-291-08508440291081 BOTTLE, PLASTIC in 1 CARTON (50844-291-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-10508440291101 BOTTLE, PLASTIC in 1 CARTON (50844-291-10) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-11508440291111 BOTTLE, PLASTIC in 1 CARTON (50844-291-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-12508440291121 BOTTLE, PLASTIC in 1 CARTON (50844-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-13508440291131 BOTTLE, PLASTIC in 1 CARTON (50844-291-13) / 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-1450844029114500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-14) 1988-05-240000-00-00NoNoCurrent
50844-291-15508440291151 BOTTLE, PLASTIC in 1 CARTON (50844-291-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-16508440291161000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-16) 1988-05-240000-00-00NoNoCurrent
50844-291-1750844029117300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-17) 1988-05-24NoNoCurrent
50844-291-24508440291242 in 1 POUCHHistorical
50844-291-29508440291291 BOTTLE, PLASTIC in 1 CARTON (50844-291-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1988-05-240000-00-00NoNoCurrent
50844-291-505084402915050 POUCH in 1 CARTON (50844-291-50) / 2 TABLET, FILM COATED in 1 POUCH (50844-291-24) 50 pouch1988-05-24NoNoCurrent
50844-291-9950844029199250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-99) 1988-05-24NoNoCurrent