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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215548-001FENOPROFEN CALCIUMFENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-16
A215548-002FENOPROFEN CALCIUMFENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-16
A215548-003FENOPROFEN CALCIUMFENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORAL2023-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORALAB2023-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORALAB2023-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL2023-05-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215548-002FENOPROFEN CALCIUMEQ 300MG BASECAPSULE / ORAL2023-05-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215548-003FENOPROFEN CALCIUMEQ 400MG BASECAPSULE / ORALAB2023-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215548-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORALAB2023-05-168072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215548-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215548-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215548-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215548-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215548-003AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215548-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215548-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215548-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215548-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215548-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215548-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215548-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215548-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215548-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215548-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215548-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215548-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215548-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215548-003AB13f0d92c62455…

Additional Listing Data#

Finished product
Yes
Brand name base
Fenoprofen Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOPROFEN CALCIUM300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0X2CW1QABJInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
56b07659-1fd8-4c3e-e063-6294a90a8908Available on FDA.report

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 CALCIUMCoral Way Pharma, LLC56b07659-1fd8-4c3e-e063-6294a90a89082026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215548
application number: ANDA215548
ndc (product): 85437-502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
85437-502-1085437050210100 CAPSULE in 1 BOTTLE (85437-502-10)100 capsule2026-07-150Current