Ibuprofen

Product NDC
50844-291
11-digit product format
508440291
Labeler code
50844
Product ID
50844-291_6de067d7-e53a-48a0-8cf4-bf7d41fa02e0
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-0184e616aacf4f…
2026-08-18 06:07:402026-07A075010-001IBUPROFEN200MGTABLET / ORAL1999-03-01caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 2 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
IbuprofenIBUPROFENNorthwind Health Company, LLCab313564-27dc-0297-e053-2a95a90a66902026-01-01WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Ibuprofen 24/7 Life by 7-ElevenIBUPROFEN TABLET, FILM COATEDLil' Drug Store Products, Inc.45b3b825-dab7-3328-e063-6294a90a7d2a2025-12-11WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Physicians Care IbuprofenIBUPROFEN 200MGAcme United Corporation490c1109-dad7-4135-e054-00144ff8d46c2025-10-31WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC6521bc47-4d9c-4a5b-b109-3841f3be4b6c2025-10-07WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INCbfda6547-19b2-4230-87a1-a68fbec740b42025-10-06WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Green Guard Ibupro reliefIBUPROFENUnifirst First Aid Corporation2923c4a3-f994-67a7-e054-00144ff8d46c2025-09-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Medique IprinIBUPROFENUnifirst First Aid Corporation2910b50b-c8de-382b-e054-00144ff88e882025-09-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Medique at Home IprinIBUPROFENUnifirst First Aid Corporationb5547f33-2a81-867d-e053-2995a90aa2d02025-09-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Direct Safety IbuprofenIBUPROFENConney Safety Products, LLC28d45743-d298-29db-e054-00144ff8d46c2025-09-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Unishield IbuprofenIBUPROFENUnishieldb9e2e2ba-e2ad-eace-e053-2995a90aed352025-09-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Uline IbuprofenIBUPROFENUlined7342a15-9d49-74ed-e053-2a95a90a22cc2025-09-09WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Henry Schein IbuprofenIBUPROFENHenry Schein Inc.267c7c8a-2f3f-1f4d-e054-00144ff8d46c2025-09-08WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
Ibuprofen ThompsonIBUPROFENThompson Safetyccfbc048-f666-3188-e053-2995a90ae08f2025-09-08WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENSam's West Inc6293a134-860d-4d12-9e4b-28490f8241082025-09-03WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENChain Drug Consortium6c593a9c-680e-4645-8e8f-d8d044c92ca12025-07-18WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENWildman Business Group9e71f1c1-5272-4209-8974-6c525b1411552024-08-19WarningsExact identifier
application applno (ANDA): 075010
application number: ANDA075010
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.3e3848f2-4922-39ea-e054-00144ff88e882024-06-25WarningsExact 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