Ketoprofen

Product NDC
63187-018
11-digit product format
631870018
Labeler code
63187
Product ID
63187-018_98c69d2c-3898-4400-aae0-cc8d17587384
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketoprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-018DDiscontinued by firm2026-08-07
excluded packagepackage63187-01863187-018-30DDiscontinued by firm2026-08-07

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 1 · 4 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 packagepackage63187-018-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-018-30f5e01cc5f278…a2eaf40c39c3…

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 Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-018KETOPROFEN CAPSULE [PROFICIENT RX LP]3Legacy NDC20191121_5b9c497c-5e32-4c77-82ab-fe6abdd9cf57.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-018-306318700183030 CAPSULE in 1 BOTTLE (63187-018-30) 30 capsule2018-11-010000-00-00NoNoCurrent