Celecoxib

Product NDC: 10544-929
11-digit product format: 105440929
Labeler code: 10544
Product ID: 10544-929_1b53f099-4eaf-2ee2-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: NDA020998
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-07-20
Marketing end: 0000-00-00
Substance: CELECOXIB
Active strength: 200 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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
10544-929-14	2020-01-31	C162847	48780-1	9d75b9d0-ca42-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
10544-929-30	2020-01-31	C162847	48780-1	9d75b9d0-ca42-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	Strength	SPL version
10544-929-14	Celecoxib	14 in 1 BOTTLE	CAPSULE	14		1
10544-929-30	Celecoxib	30 in 1 BOTTLE	CAPSULE	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-929	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1	Legacy NDC, 2 package rows	20150721_1b53f099-4eae-2ee2-e054-00144ff88e88.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	1b53f099-4eae-2ee2-e054-00144ff88e88	1
205323	celecoxib 200 MG Oral Capsule	SCD	1b53f099-4eae-2ee2-e054-00144ff88e88	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-929-14	10544092914	14 in 1 BOTTLE	Historical
10544-929-30	10544092930	30 in 1 BOTTLE	Historical