Celecoxib

Product NDC: 45865-840
11-digit product format: 458650840
Labeler code: 45865
Product ID: 45865-840_9ab47faa-a90e-a695-e053-2a95a90a270e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: NDA020998
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2014-12-10
Marketing end: 0000-00-00
Substance: CELECOXIB
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: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9a	Product name	1	20200925
827beb42-45f2-95b8-6aa3-f35174375422	Product name	9	20160429

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-840-30	2023-01-30	C162847	48780-1	f386c649-a749-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib Capsules Initial U.S. Approval: 1998
45865-840-60	2023-01-30	C162847	48780-1	f386c649-a749-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for celecoxib. Celecoxib Capsules Initial U.S. Approval: 1998

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-840-30	Celecoxib	30 in 1 BOTTLE	CAPSULE	30		2
45865-840-60	Celecoxib	60 in 1 BOTTLE	CAPSULE	60		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-840	CELECOXIB CAPSULE [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 2 package rows	20191228_2087ead6-69b3-5f5a-e054-00144ff8d46c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JCX84Q7J1L	CELECOXIB	169590-42-5	CELECOXIB

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205323	celecoxib 200 MG Oral Capsule	PSN	2087ead6-69b3-5f5a-e054-00144ff8d46c	2
205323	celecoxib 200 MG Oral Capsule	SCD	2087ead6-69b3-5f5a-e054-00144ff8d46c	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-840-30	45865084030	30 CAPSULE in 1 BOTTLE (45865-840-30)	30 capsule	2015-09-24	0000-00-00	No	No	Current
45865-840-60	45865084060	60 CAPSULE in 1 BOTTLE (45865-840-60)	60 capsule	2015-09-24	0000-00-00	No	No	Current