Celecoxib

Product NDC: 53217-157
11-digit product format: 532170157
Labeler code: 53217
Product ID: 53217-157_b1418125-e23b-471e-acae-0295519300a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
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: 2019-12-31
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
53217-157-01	2020-01-31	C162847	48780-1	9d75b9d1-0a2c-f424-e053-dadaa90a57ce	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
53217-157-30	2020-01-31	C162847	48780-1	9d75b9d1-0a2c-f424-e053-dadaa90a57ce	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
53217-157-55	2020-01-31	C162847	48780-1	9d75b9d1-0a2c-f424-e053-dadaa90a57ce	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
53217-157-60	2020-01-31	C162847	48780-1	9d75b9d1-0a2c-f424-e053-dadaa90a57ce	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	SPL version
53217-157-01	Celecoxib	100 in 1 BOTTLE	CAPSULE	100	1
53217-157-30	Celecoxib	30 in 1 BOTTLE	CAPSULE	30	1
53217-157-55	Celecoxib	500 in 1 BOTTLE	CAPSULE	500	1
53217-157-60	Celecoxib	60 in 1 BOTTLE	CAPSULE	60	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-157	CELECOXIB CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 4 package rows	20150329_41b4dd3f-844c-4f98-8a1c-6df13436b712.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
205322	celecoxib 100 MG Oral Capsule	PSN	41b4dd3f-844c-4f98-8a1c-6df13436b712	1
205323	celecoxib 200 MG Oral Capsule	PSN	41b4dd3f-844c-4f98-8a1c-6df13436b712	1
205322	celecoxib 100 MG Oral Capsule	SCD	41b4dd3f-844c-4f98-8a1c-6df13436b712	1
205323	celecoxib 200 MG Oral Capsule	SCD	41b4dd3f-844c-4f98-8a1c-6df13436b712	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-157-01	53217015701	100 in 1 BOTTLE	Historical
53217-157-30	53217015730	30 in 1 BOTTLE	Historical
53217-157-55	53217015755	500 in 1 BOTTLE	Historical
53217-157-60	53217015760	60 in 1 BOTTLE	Historical