Home NDC 85477-111 Ketoprofen
Product NDC 85477-111
11-digit product format 854770111
Labeler code 85477
Product ID 85477-111_0b2637a6-551b-4be3-8d1a-dad8fbf764b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketoprofen
Dosage form CAPSULE
Route ORAL
Labeler Oncora Pharma, LLC
Application ANDA074014
Marketing category ANDA
Marketing start 2026-03-01
Substance KETOPROFEN
Active strength 50 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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074014-001 KETOPROFEN KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 A074014-002 KETOPROFEN KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 A074014-003 KETOPROFEN KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074014-002 AB
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 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074014-002 KETOPROFEN 50MG CAPSULE / ORAL AB 1993-01-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074014-003 KETOPROFEN 75MG CAPSULE / ORAL RS 1993-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074014-001 KETOPROFEN 25MG CAPSULE / ORAL 1993-01-29 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 49 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ketoprofen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOPROFEN 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 90Y4QC304K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197855 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85477-111-01 Ketoprofen 100 in 1 BOTTLE CAPSULE 100 2
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 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ketoprofen KETOPROFEN Marnel Pharmaceuticals, Inc. 4e7bceb6-dcb5-c5e0-e063-6294a90a101e 2026-04-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074014 application number: ANDA074014 Ketoprofen KETOPROFEN Oncora Pharma, LLC 492de5dc-7c1b-47be-8510-43be4e1fd4ed 2026-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074014 application number: ANDA074014 ndc (product): 85477-111 Ketoprofen KETOPROFEN Misemer Pharmaceuticals, Inc. d0f47ab6-29ff-df07-e053-2a95a90a2b51 2026-02-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074014 application number: ANDA074014 Orudis KETOPROFEN Allegis Pharmaceuticals, Inc. 47d0b808-7142-c7a9-e063-6394a90a6e0d 2026-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074014 application number: ANDA074014
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85477-111-01 85477011101 100 CAPSULE in 1 BOTTLE (85477-111-01) 100 capsule 2026-03-01 No No Current