FENOPRON

Product NDC: 61825-311
11-digit product format: 618250311
Labeler code: 61825
Product ID: 61825-311_1ad61a67-8758-4f2f-b7d5-f00f62ea69aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOPROFEN CALCIUM
Dosage form: CAPSULE
Route: ORAL
Labeler: Galt Pharmaceuticals, LLC
Application: ANDA214475
Marketing category: ANDA
Marketing start: 2024-12-10
Substance: FENOPROFEN CALCIUM
Active strength: 300 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

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	RLD / RS	Approval date
A214475-001	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	RS	2022-07-18
A214475-002	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL		2024-07-26
A214475-003	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL		2024-07-26

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 · 47 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	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL		RS	2022-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214475-002	FENOPROFEN CALCIUM	EQ 200MG BASE	CAPSULE / ORAL			2024-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214475-003	FENOPROFEN CALCIUM	EQ 300MG BASE	CAPSULE / ORAL			2024-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	2022-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	2022-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB	RS	2022-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214475-001	FENOPROFEN CALCIUM	EQ 400MG BASE	CAPSULE / ORAL	AB		2022-07-18	`053a50430f4f…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214475-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214475-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214475-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214475-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214475-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214475-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214475-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214475-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214475-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214475-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214475-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214475-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214475-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214475-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214475-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214475-001	AB	1	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A214475-001	CGT	2023-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214475-001	CGT	2023-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214475-001	CGT	2023-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214475-001	CGT	2023-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214475-001	CGT	2023-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214475-001	CGT	2023-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214475-001	CGT	2023-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214475-001	CGT	2023-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214475-001	CGT	2023-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214475-001	CGT	2023-02-11	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: FENOPRON
Brand name suffix: TM
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197695	Internal RxNorm lookup
2699827	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0916fe0d-58e1-5e07-2471-9a804a1b0628	Product name	3	20240514
090af53b-bc54-1ac8-5eee-2f06b5d9cff9	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61825-311-10	FENOPRONTM	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61825-311-10	EA - Each	61825-311	1f7abda3-7527-48da-8709-87be68ee961c	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61825-311	FENOPRON TM (FENOPROFEN CALCIUM) CAPSULE [GALT PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20241220_2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenoprofen calcium	FENOPROFEN CALCIUM	Atland Pharmaceuticals, LLC	b26c8351-a955-4685-adad-a7233db39d92	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214475 application number: ANDA214475
FENOPRON TM	FENOPROFEN CALCIUM	Galt Pharmaceuticals, LLC	2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214475 application number: ANDA214475 ndc (product): 61825-311
FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	Rising Pharma Holdings, Inc.	4aa38cca-9f8f-4ab6-8103-4f1f48801a43	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214475 application number: ANDA214475
FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	Atland Pharmaceuticals, LLC	3daa336f-2acf-4109-a360-b1d30b192d41	2024-03-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214475 application number: ANDA214475
FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	Proficient Rx LP	1d438989-6431-4c62-8f24-444475d423a3	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214475 application number: ANDA214475

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0X2CW1QABJ	FENOPROFEN CALCIUM	53746-45-5	FENOPROFEN CALCIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197695	fenoprofen calcium 300 MG Oral Capsule	PSN	2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0	3
2699827	Fenopron 300 MG Oral Capsule	PSN	2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0	3
2699827	fenoprofen 300 MG Oral Capsule [Fenopron]	SBD	2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0	3
197695	fenoprofen 300 MG Oral Capsule	SCD	2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0	3
197695	fenoprofen (as fenoprofen calcium) 300 MG Oral Capsule	SY	2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0	3
2699827	Fenopron (as fenoprofen calcium) 300 MG Oral Capsule	SY	2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61825-311-10	61825031110	100 CAPSULE in 1 BOTTLE (61825-311-10)	100 capsule	2024-12-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENOPRON TM	Galt Pharmaceuticals, LLC \| Rising Pharma Holdings, Inc. \| Cohance LifesciencesLimited	2026-02-16	HUMAN PRESCRIPTION DRUG LABEL	3