Fenoprofen Calcium

Product NDC: 0276-0502
11-digit product format: 002760502
Labeler code: 0276
Product ID: 0276-0502_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: 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

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0276-0502-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0276-0502-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0276-0502-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0276-0502-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0276-0502-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0276-0502-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215548-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215548-002	AB	1	`caaa826d4ba7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215548-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215548-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215548-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215548-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215548-003	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215548-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215548-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215548-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215548-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215548-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215548-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215548-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215548-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215548-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215548-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215548-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215548-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215548-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215548-003	AB	1	`3f0d92c62455…`

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	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 · 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d33ad329-1ca6-ac2e-e053-2995a90a15c5	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
0276-0502-10	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
0276-0502	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenoprofen Calcium	FENOPROFEN CALCIUM	Misemer Pharmaceuticals, Inc.	d33ad329-1ca6-ac2e-e053-2995a90a15c5	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215548 application number: ANDA215548 ndc (product): 0276-0502
Fenoprofen Calcium	FENOPROFEN CALCIUM	Coral Way Pharma, LLC	56b07659-1fd8-4c3e-e063-6294a90a8908	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215548 application number: ANDA215548

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
197694	fenoprofen calcium 200 MG Oral Capsule	PSN	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5
197695	fenoprofen calcium 300 MG Oral Capsule	PSN	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5
858116	fenoprofen calcium 400 MG Oral Capsule	PSN	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5
197694	fenoprofen 200 MG Oral Capsule	SCD	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5
197695	fenoprofen 300 MG Oral Capsule	SCD	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5
858116	fenoprofen 400 MG Oral Capsule	SCD	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5
197694	fenoprofen (as fenoprofen calcium) 200 MG Oral Capsule	SY	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5
197695	fenoprofen (as fenoprofen calcium) 300 MG Oral Capsule	SY	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5
858116	fenoprofen (as fenoprofen calcium) 400 MG Oral Capsule	SY	d33ad329-1ca6-ac2e-e053-2995a90a15c5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0276-0502-10	00276050210	100 CAPSULE in 1 BOTTLE (0276-0502-10)	100 capsule	2023-11-01	0000-00-00	No	No	Current