Ketoprofen

Product NDC
21695-341
11-digit product format
216950341
Labeler code
21695
Product ID
21695-341_9bc31f67-cfce-4ad6-9c07-3845ead3542c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074035
Marketing category
ANDA
Marketing start
2010-04-20
Marketing end
0000-00-00
Substance
KETOPROFEN
Active strength
75 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-341IInactivated by FDA2026-08-07
excluded packagepackage21695-34121695-341-21IInactivated by FDA2026-08-07
excluded packagepackage21695-34121695-341-30IInactivated by FDA2026-08-07
excluded packagepackage21695-34121695-341-42IInactivated by FDA2026-08-07
excluded packagepackage21695-34121695-341-60IInactivated 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 · 110 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 packagepackage21695-341-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-341-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-341-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-341-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-341-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-341-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-341-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-341-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-341-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-341-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-341-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-341-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-341-42a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-341-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-341-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-341-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-341-42cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-341-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-341-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-341-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-341-42cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-341-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-341-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-341-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-341-42302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-341-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-341-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-341-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-341-42ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-341-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-341-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-341-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-341-420efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-341-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-341-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-341-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-341-42ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-341-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-341-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-341-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-341-42367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-341-21367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-341-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-341-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-341-42557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-341-21557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-341-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-341-60557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074035-002KETOPROFENKETOPROFEN50MGCAPSULE / ORAL1996-12-31
A074035-003KETOPROFENKETOPROFEN75MGCAPSULE / ORAL1996-12-31

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074035-002KETOPROFEN50MGCAPSULE / ORAL1996-12-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A074035-003KETOPROFEN75MGCAPSULE / ORAL1996-12-31782e0a99824c…

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
21695-341-21Ketoprofen21 in 1 BOTTLECAPSULE211
21695-341-30Ketoprofen30 in 1 BOTTLECAPSULE301
21695-341-42Ketoprofen42 in 1 BOTTLECAPSULE421
21695-341-60Ketoprofen60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-341-21EA - Each21695-3414a298dbe-6507-4abb-82a1-49e88dd7242712012-07-24
21695-341-30EA - Each21695-341b3ee56bc-3522-46cd-97b0-59fb14362b0312012-07-24
21695-341-42EA - Each21695-341e5d66984-66ee-42fb-917d-cfb69c5f3c9612012-07-24
21695-341-60EA - Each21695-341a53fb53b-c7b3-485f-aaf4-cd42ca91cb7612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOPROFENACTIVE INGREDIENT90Y4QC304KKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
KETOPROFENACTIVE MOIETY90Y4QC304KKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-341KETOPROFEN CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20110104_9bc31f67-cfce-4ad6-9c07-3845ead3542c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197855ketoprofen 50 MG Oral CapsulePSN9bc31f67-cfce-4ad6-9c07-3845ead3542c1
197856ketoprofen 75 MG Oral CapsulePSN9bc31f67-cfce-4ad6-9c07-3845ead3542c1
197855ketoprofen 50 MG Oral CapsuleSCD9bc31f67-cfce-4ad6-9c07-3845ead3542c1
197856ketoprofen 75 MG Oral CapsuleSCD9bc31f67-cfce-4ad6-9c07-3845ead3542c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-341-212169503412121 in 1 BOTTLEHistorical
21695-341-302169503413030 in 1 BOTTLEHistorical
21695-341-422169503414242 in 1 BOTTLEHistorical
21695-341-602169503416060 in 1 BOTTLEHistorical