Celecoxib

Product NDC: 10544-918
11-digit product format: 105440918
Labeler code: 10544
Product ID: 10544-918_17395669-5982-4536-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmcal, Inc
Application: NDA020998
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-05-27
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
10544-918-14	2020-01-31	C162847	48780-1	9d75b9d0-9da2-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
10544-918-30	2020-01-31	C162847	48780-1	9d75b9d0-9da2-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
10544-918-14	Celecoxib	14 in 1 BOTTLE	CAPSULE	14		2
10544-918-30	Celecoxib	30 in 1 BOTTLE	CAPSULE	30		2

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-918	CELECOXIB CAPSULE [BLENHEIM PHARMCAL, INC]	2	Legacy NDC, 2 package rows	20150529_1716195a-4c64-3612-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	1716195a-4c64-3612-e054-00144ff88e88	2
205323	celecoxib 200 MG Oral Capsule	SCD	1716195a-4c64-3612-e054-00144ff88e88	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-918-14	10544091814	14 in 1 BOTTLE	Historical
10544-918-30	10544091830	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	Blenheim Pharmcal, Inc \| Blenheim Pharmacal, Inc.	2015-05-29	HUMAN PRESCRIPTION DRUG LABEL	2