Fenoprofen Calcium

Product NDC: 50090-3572
11-digit product format: 500903572
Labeler code: 50090
Product ID: 50090-3572_209bc361-7d05-426f-9c63-5f8f92153664
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenoprofen calcium
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA017604
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-05-19
Marketing end: 0000-00-00
Substance: FENOPROFEN CALCIUM
Active strength: 400 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: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0916fe0d-58e1-5e07-2471-9a804a1b0628	Product name	3	20240514
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
090af53b-bc54-1ac8-5eee-2f06b5d9cff9	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3572-0	2023-01-30	C162847	48780-1	f386c64a-3f7e-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Fenoprofen Calcium Capsules, USP safely and effectively. See full prescribing information for Fenoprofen Calcium Capsules, USP. Fenoprofen Calcium Capsules, USP for oral use Initial U.S. Approval: 1982

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3572-0	Fenoprofen Calcium	90 in 1 BOTTLE	CAPSULE	90		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3572	FENOPROFEN CALCIUM CAPSULE [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 1 package rows	20200121_1a6aeca8-82c9-4bf7-99ad-6d065032762b.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858116	fenoprofen calcium 400 MG Oral Capsule	PSN	1a6aeca8-82c9-4bf7-99ad-6d065032762b	4
858116	fenoprofen 400 MG Oral Capsule	SCD	1a6aeca8-82c9-4bf7-99ad-6d065032762b	4
858116	fenoprofen (as fenoprofen calcium) 400 MG Oral Capsule	SY	1a6aeca8-82c9-4bf7-99ad-6d065032762b	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3572-0	50090357200	90 CAPSULE in 1 BOTTLE (50090-3572-0)	90 capsule	2018-09-06	0000-00-00	No	No	Current