Home NDC 85437-502 Fenoprofen Calcium
Product NDC 85437-502
11-digit product format 854370502
Labeler code 85437
Product ID 85437-502_56b075a0-c313-b6cb-e063-6394a90a72fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenoprofen Calcium
Dosage form CAPSULE
Route ORAL
Labeler Coral Way Pharma, LLC
Application ANDA215548
Marketing category ANDA
Marketing start 2026-07-15
Substance FENOPROFEN CALCIUM
Active strength 300 mg/1
Pharmacologic classes Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
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 A215548-001 FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 A215548-002 FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 A215548-003 FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16
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 · 66 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 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL AB 2023-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL AB 2023-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL 2023-05-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL AB 2023-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL AB 2023-05-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fenoprofen Calcium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENOPROFEN CALCIUM 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0X2CW1QABJ Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 85437-502-10 85437050210 100 CAPSULE in 1 BOTTLE (85437-502-10) 100 capsule 2026-07-15 0 Current