Home NDC 0276-0501 Fenoprofen Calcium
Product NDC 0276-0501
11-digit product format 002760501
Labeler code 0276
Product ID 0276-0501_597fecff-90ac-274c-e063-6294a90a1609
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenoprofen Calcium
Dosage form CAPSULE
Route ORAL
Labeler Misemer Pharmaceuticals, Inc.
Application ANDA215548
Marketing category ANDA
Marketing start 2023-11-01
Substance FENOPROFEN CALCIUM
Active strength 200 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 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0276-0501-10 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0276-0501-10 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0276-0501-10 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0276-0501-10 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0276-0501-10 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0276-0501-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0276-0501-10 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0276-0501-10 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0276-0501-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0276-0501-10 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0276-0501-10 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0276-0501-10 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 0276-0501-10 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 0276-0501-10 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 0276-0501-10 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 AB 2023-05-16 A215548-003 FENOPROFEN CALCIUM FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215548-002 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 2 · 72 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 2026-09-14 22:38:34 2026-08 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL AB 2023-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215548-001 FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE / ORAL 2023-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215548-002 FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE / ORAL AB 2023-05-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215548-003 FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE / ORAL 2023-05-16 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 200 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197694 Internal RxNorm lookup 197695 Internal RxNorm lookup 858116 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2025-02-04 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2025-02-04 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2025-02-04 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2025-02-04 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2025-02-04 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2024-01-30 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2024-01-30 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2024-01-30 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2024-01-30 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982 2024-01-30 These highlights do not include all the information needed to use Fenoprofen Calcium safely and effectively. See full prescribing information for Fenoprofen Calcium. Fenoprofen Calcium, capsules, for oral use Initial U.S. Approval: 1982
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0276-0501-10 Fenoprofen Calcium 100 in 1 BOTTLE CAPSULE 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0276-0501 FENOPROFEN CALCIUM CAPSULE [MISEMER PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250206_d33ad329-1ca6-ac2e-e053-2995a90a15c5.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0276-0501-10 00276050110 100 CAPSULE in 1 BOTTLE (0276-0501-10) 100 capsule 2023-11-01 0000-00-00 No No Current