Home NDC 85437-502-10 Fenoprofen Calcium
Product NDC 85437-502
Requested package NDC 85437-502-10
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.
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