Ketoprofen

Product NDC
33261-064
11-digit product format
332610064
Labeler code
33261
Product ID
33261-064_db694f6b-8c95-4f66-9b6e-5ab64d416abe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA073517
Marketing category
ANDA
Marketing start
1993-01-01
Marketing end
0000-00-00
Substance
KETOPROFEN
Active strength
75 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-064IInactivated by FDA2026-08-07
excluded packagepackage33261-06433261-064-60IInactivated by FDA2026-08-07
excluded packagepackage33261-06433261-064-90IInactivated by FDA2026-08-07
excluded packagepackage33261-06433261-064-97IInactivated by FDA2026-08-07

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 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-064-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-064-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-064-97d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-064-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-064-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-064-97f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-064-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-064-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-064-972ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-064-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-064-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-064-97a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-064-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-064-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-064-97cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-064-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-064-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-064-97cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-064-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-064-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-064-97302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-064-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-064-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-064-97ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-064-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-064-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-064-970efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-064-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-064-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-064-97ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-064-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-064-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-064-97367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-064-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-064-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-064-97557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-064-908af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-064-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-064-978af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-064-90834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-064-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-064-97834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-064-901332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-064-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-064-971332a3947898…d4bfe170f9cd…

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
A073517-001KETOPROFENKETOPROFEN75MGCAPSULE / ORAL1992-12-22

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 UTC2026-02A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073517-001KETOPROFEN75MGCAPSULE / ORALABRS1992-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073517-001KETOPROFEN75MGCAPSULE / ORALABRS1992-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A073517-001KETOPROFEN75MGCAPSULE / ORALABRS1992-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073517-001KETOPROFEN75MGCAPSULE / ORALABRS1992-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073517-001KETOPROFEN75MGCAPSULE / ORALABRS1992-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073517-001KETOPROFEN75MGCAPSULE / ORALABRS1992-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A073517-001KETOPROFEN75MGCAPSULE / ORALABRS1992-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A073517-001KETOPROFEN75MGCAPSULE / ORALABRS1992-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073517-001KETOPROFEN75MGCAPSULE / ORAL1992-12-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A073517-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073517-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A073517-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073517-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073517-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073517-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073517-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073517-001AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
460c0bb5-c2b5-c96e-0f79-68a0385a39a0Product name220201015

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-064-60Ketoprofen60 in 1 BOTTLE, PLASTICCAPSULE601
33261-064-90Ketoprofen90 in 1 BOTTLE, PLASTICCAPSULE901
33261-064-97Ketoprofen126 in 1 BOTTLE, PLASTICCAPSULE1261

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-064-60EA - Each33261-06429c2df80-5237-40fb-9069-c258a61a2de512015-10-02
33261-064-90EA - Each33261-064ba200d4a-c72f-460a-b962-c8f886f3425412014-02-04
33261-064-97EA - Each33261-06432cabcc3-bb03-475b-bb98-958bc9c0b2aa12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOPROFENACTIVE INGREDIENT90Y4QC304KKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
KETOPROFENACTIVE MOIETY90Y4QC304KKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2KETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-064KETOPROFEN CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140110_4bfd7816-73c1-49c4-833e-a8e5a6a7bd64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197856ketoprofen 75 MG Oral CapsulePSN4bfd7816-73c1-49c4-833e-a8e5a6a7bd641
197856ketoprofen 75 MG Oral CapsuleSCD4bfd7816-73c1-49c4-833e-a8e5a6a7bd641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-064-603326100646060 in 1 BOTTLE, PLASTICHistorical
33261-064-903326100649090 in 1 BOTTLE, PLASTICHistorical
33261-064-9733261006497126 in 1 BOTTLE, PLASTICHistorical