FENORTHO

Product NDC
69336-113
11-digit product format
693360113
Labeler code
69336
Product ID
69336-113_bedf1661-b811-3d85-e053-2995a90acd59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENORTHO
Dosage form
CAPSULE
Route
ORAL
Labeler
Sterling Knight Pharmaceuticals LLC
Application
NDA017604
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-03-21
Marketing end
0000-00-00
Substance
FENOPROFEN CALCIUM
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69336-113DDiscontinued by firm2026-08-10
excluded packagepackage69336-11369336-113-10DDiscontinued by firm2026-08-10
excluded packagepackage69336-11369336-113-90DDiscontinued 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 · 42 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 packagepackage69336-113-10DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69336-113-90DDiscontinued 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 packagepackage69336-113-10DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69336-113-90DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69336-113-10DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69336-113-90DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69336-113-10DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69336-113-90DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69336-113-10DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69336-113-90DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69336-113-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69336-113-90DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69336-113-10DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69336-113-90DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69336-113-10DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69336-113-90DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69336-113-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69336-113-90DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69336-113-10DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69336-113-90DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69336-113-10DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69336-113-90DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69336-113-10DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69336-113-90DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69336-113-90IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69336-113-10IInactivated 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 packagepackage69336-113-90IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69336-113-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
69336-113-10EA - Each69336-11340b47007-01b6-43af-9034-aa9406d37b2a12017-04-05

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69336-113-1069336011310100 CAPSULE in 1 BOTTLE (69336-113-10) 100 capsule2017-03-210000-00-00NoNoCurrent
69336-113-906933601139090 CAPSULE in 1 BOTTLE (69336-113-90) 90 capsule2017-03-210000-00-00NoNoCurrent