FENOPROFEN

Product NDC
62250-691
11-digit product format
622500691
Labeler code
62250
Product ID
62250-691_e2def58f-218d-4de9-bb88-c03cec0aef0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENOPROFEN CALCIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Belcher Pharmaceuticals,LLC
Application
NDA017604
Marketing category
NDA
Marketing start
2017-04-19
Marketing end
0000-00-00
Substance
FENOPROFEN CALCIUM
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct62250-691DDiscontinued by firm2026-08-10
excluded packagepackage62250-69162250-691-02DDiscontinued by firm2026-08-10

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62250-691-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62250-691-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62250-691-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62250-691-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62250-691-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62250-691-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62250-691-02IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62250-691-02IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62250-691-02IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62250-691-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62250-691-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62250-691-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage62250-691-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage62250-691-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage62250-691-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage62250-691-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage62250-691-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage62250-691-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage62250-691-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage62250-691-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage62250-691-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage62250-691-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017604-002NALFONFENOPROFEN CALCIUMEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982
N017604-003NALFONFENOPROFEN CALCIUMEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N017604-004NALFONFENOPROFEN CALCIUMEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2009-07-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017604-003NALFONEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017604-004NALFONEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2009-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017604-003NALFONEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017604-004NALFONEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2009-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017604-003NALFONEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017604-004NALFONEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2009-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD2009-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05N017604-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017604-004AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017604-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017604-004AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017604-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N017604-004AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017604-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N017604-004AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017604-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017604-004AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017604-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017604-004AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017604-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017604-004AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017604-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017604-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017604-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017604-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017604-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017604-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017604-004AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62250-691-02EA - Each62250-6915ad2a9d8-6805-41ef-9f81-b3d261ae93ce12017-05-04

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fenoprofen CalciumFENOPROFEN CALCIUMMisemer Pharmaceuticals, Inc.d33ad329-1ca6-ac2e-e053-2995a90a15c52026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 017604
application number: NDA017604