ibuprofen

Product NDC
59779-604
11-digit product format
597790604
Labeler code
59779
Product ID
59779-604_c61238a8-2d64-484b-84d9-6ad48a3c8526
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA072096
Marketing category
ANDA
Marketing start
2001-07-10
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-60459779-604-02DDiscontinued by firm2026-08-17
excluded packagepackage59779-60459779-604-47DDiscontinued by firm2026-08-17
excluded packagepackage59779-60459779-604-52DDiscontinued by firm2026-08-17
excluded packagepackage59779-60459779-604-59DDiscontinued by firm2026-08-17
excluded packagepackage59779-60459779-604-72DDiscontinued by firm2026-08-17
excluded packagepackage59779-60459779-604-76DDiscontinued by firm2026-08-17
excluded packagepackage59779-60459779-604-85DDiscontinued by firm2026-08-17
excluded packagepackage59779-60459779-604-87DDiscontinued by firm2026-08-17
excluded packagepackage59779-60459779-604-93DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 85 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0559779-604-59d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-604-76d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-604-72d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-604-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-604-52d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-604-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-604-85d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-604-47d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2659779-604-76f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-604-47f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-604-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-604-59f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-604-52f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-604-85f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-604-72f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3159779-604-762ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-604-472ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-604-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-604-592ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-604-522ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-604-852ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-604-722ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2859779-604-76a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-604-47a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-604-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-604-59a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-604-52a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-604-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-604-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2159779-604-76cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-604-47cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-604-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-604-59cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-604-52cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-604-85cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-604-72cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1059779-604-76cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-604-47cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-604-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-604-59cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-604-52cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-604-85cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-604-72cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3159779-604-76302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-604-47302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-604-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-604-59302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-604-52302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-604-85302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-604-72302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2059779-604-76ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-604-47ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-604-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-604-59ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-604-52ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-604-85ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-604-72ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1059779-604-760efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059779-604-470efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059779-604-020efc9e666f02…f202fb6c5f17…

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
A072096-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1987-12-08

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 06:07:402026-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A072096-001IBUPROFEN200MGTABLET / ORAL1987-12-08e64feba35796…

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
ace493e6-91bc-41aa-8e5c-5bc14981de91Available 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
59779-604-00ibuprofen500 in 1 BOTTLETABLET, FILM COATED50014
59779-604-00ibuprofen2 in 1 PACKAGETABLET, FILM COATED214
59779-604-02ibuprofen550 in 1 BOTTLETABLET, FILM COATED55014
59779-604-47ibuprofen150 in 1 BOTTLETABLET, FILM COATED15014
59779-604-52ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-52ibuprofen10 in 1 BOTTLETABLET, FILM COATED1014
59779-604-59ibuprofen750 in 1 BOTTLETABLET, FILM COATED75014
59779-604-62ibuprofen24 in 1 BOTTLETABLET, FILM COATED2414
59779-604-62ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-71ibuprofen50 in 1 BOTTLETABLET, FILM COATED5014
59779-604-71ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-72ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-72ibuprofen60 in 1 BOTTLETABLET, FILM COATED6014
59779-604-76ibuprofen120 in 1 BOTTLETABLET, FILM COATED12014
59779-604-76ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-78ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-78ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
59779-604-82ibuprofen2 in 1 CARTONTABLET, FILM COATED214
59779-604-82ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
59779-604-85ibuprofen250 in 1 BOTTLETABLET, FILM COATED25014
59779-604-85ibuprofen1 in 1 CARTONTABLET, FILM COATED114
59779-604-87ibuprofen300 in 1 BOTTLETABLET, FILM COATED30014
59779-604-90ibuprofen500 in 1 BOTTLETABLET, FILM COATED50014
59779-604-93ibuprofen1000 in 1 BOTTLETABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-604-62EA - Each59779-604748f8d53-38b2-4155-9ddb-3bd30af6ab8512018-05-09
59779-604-82EA - Each59779-604345add93-8d0b-4205-ba8e-9c32bf9879ae12018-01-12
59779-604-90EA - Each59779-604c09abce4-fe8b-4afe-a2f1-464edbaf571312018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [CVS PHARMACY]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [CVS PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [CVS PHARMACY]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [CVS PHARMACY]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET [CVS PHARMACY]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET [CVS PHARMACY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [CVS PHARMACY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [CVS PHARMACY]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET [CVS PHARMACY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [CVS PHARMACY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [CVS PHARMACY]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [CVS PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [CVS PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-604IBUPROFEN TABLET, FILM COATED [CVS PHARMACY]12Current NDC, Legacy NDC, 24 package rows20221229_ace493e6-91bc-41aa-8e5c-5bc14981de91.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 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Berkley and Jensen IbuprofenIBUPROFENBJWCcda57e42-6106-46ee-82d1-479a692ee5bb2026-05-21WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen085dcc1a-e4b0-4d08-9476-72275382d1a12026-05-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.f1a03b1f-2d87-43cc-b256-bd296ccd09f22026-05-13WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENKroger Company6307485a-8be6-40ee-899b-00eb3ee8ce612026-05-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
CounterAct IBIBUPROFENMelaleuca, Inc7fafc13e-3fee-ace3-e053-2a91aa0ac2ea2026-03-17Boxed warning, WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
Leader IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderd673266c-3d2b-479f-9b53-cdd1b86513932026-02-25WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc4c24c884-55f7-40b4-8d6f-db6144d5ebcb2026-02-05WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENHyVee Inc5233c409-3743-4312-9f75-14ded6755b5c2026-02-02WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ndc (product): 59779-604
ibuprofenIBUPROFENNorthwind Health Company, LLCda6c2802-5d15-dbcb-e053-2a95a90a25612026-01-01WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENL. Perrigo Company70d0a429-27c1-43a5-b2ea-a9919e0910f82025-12-22WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
ibuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.96bff700-bca3-4b94-b8a2-379102721db82025-12-15WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.c447fc6b-e9ef-447a-9609-5f893e18dfa72025-11-17WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096
GOODNOW PAIN RELIEFIBUPROFENGobrands, Inc0759085d-6ac3-446b-ac2c-8dc30e32e1d12025-11-08WarningsExact identifier
application applno (ANDA): 072096
application number: ANDA072096

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNace493e6-91bc-41aa-8e5c-5bc14981de9114
310965ibuprofen 200 MG Oral TabletSCDace493e6-91bc-41aa-8e5c-5bc14981de9114
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYace493e6-91bc-41aa-8e5c-5bc14981de9114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-604-00597790604002 BOTTLE in 1 PACKAGE (59779-604-00) / 500 TABLET, FILM COATED in 1 BOTTLE2 bottle2025-04-15NoNoCurrent
59779-604-0259779060402550 TABLET, FILM COATED in 1 BOTTLE (59779-604-02) 2016-08-030000-00-00NoNoCurrent
59779-604-4759779060447150 TABLET, FILM COATED in 1 BOTTLE (59779-604-47) 2015-09-150000-00-00NoNoCurrent
59779-604-52597790604521 in 1 CARTONHistorical
59779-604-5959779060459750 in 1 BOTTLEHistorical
59779-604-62597790604621 BOTTLE in 1 CARTON (59779-604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-07-310000-00-00NoNoCurrent
59779-604-71597790604711 BOTTLE in 1 CARTON (59779-604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-07-310000-00-00NoNoCurrent
59779-604-72597790604721 in 1 CARTONHistorical
59779-604-76597790604761 BOTTLE in 1 CARTON (59779-604-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2003-03-110000-00-00NoNoCurrent
59779-604-78597790604781 BOTTLE in 1 CARTON (59779-604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2001-07-310000-00-00NoNoCurrent
59779-604-82597790604822 BOTTLE in 1 CARTON (59779-604-82) / 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2010-03-030000-00-00NoNoCurrent
59779-604-8559779060485250 in 1 BOTTLEHistorical
59779-604-8759779060487300 TABLET, FILM COATED in 1 BOTTLE (59779-604-87) 2016-11-210000-00-00NoNoCurrent
59779-604-9059779060490500 TABLET, FILM COATED in 1 BOTTLE (59779-604-90) 2001-07-100000-00-00NoNoCurrent
59779-604-93597790604931000 TABLET, FILM COATED in 1 BOTTLE (59779-604-93) 2008-04-090000-00-00NoNoCurrent