CELEBREX

Product NDC: 61919-046
11-digit product format: 619190046
Labeler code: 61919
Product ID: 61919-046_94e096d2-5478-4e7c-e053-2a95a90a221c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CELEBREX
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct Rx
Application: NDA020998
Marketing category: NDA
Marketing start: 2014-01-01
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
61919-046-15	2023-01-30	C162847	48780-1	f386c649-ca28-0266-e053-dadaa90a7c1a	CELEBREX
61919-046-30	2023-01-30	C162847	48780-1	f386c649-ca28-0266-e053-dadaa90a7c1a	CELEBREX
61919-046-60	2023-01-30	C162847	48780-1	f386c649-ca28-0266-e053-dadaa90a7c1a	CELEBREX
61919-046-90	2023-01-30	C162847	48780-1	f386c649-ca28-0266-e053-dadaa90a7c1a	CELEBREX

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-046-15	CELEBREX	15 in 1 BOTTLE	CAPSULE	15	5
61919-046-30	CELEBREX	30 in 1 BOTTLE	CAPSULE	30	5
61919-046-60	CELEBREX	60 in 1 BOTTLE	CAPSULE	60	5
61919-046-90	CELEBREX	90 in 1 BOTTLE	CAPSULE	90	5

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-046-30	EA - Each	61919-046	bab4d4ae-84bb-4757-90df-42575e833528	1	2014-12-01
61919-046-60	EA - Each	61919-046	9e4b1bcb-6db0-45bc-9d45-d2f2b0dba061	1	2014-12-01

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELEBREX CAPSULE [DIRECT RX]	1
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELEBREX CAPSULE [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CELEBREX CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELEBREX CAPSULE [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CELEBREX CAPSULE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELEBREX CAPSULE [DIRECT RX]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELEBREX CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELEBREX CAPSULE [DIRECT RX]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-046	CELEBREX CAPSULE [DIRECT RX]	5	Legacy NDC, 4 package rows	20191017_a645dfcd-7343-4c79-af8b-1117e4a5b113.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	a645dfcd-7343-4c79-af8b-1117e4a5b113	5
205323	celecoxib 200 MG Oral Capsule	SCD	a645dfcd-7343-4c79-af8b-1117e4a5b113	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-046-15	61919004615	15 CAPSULE in 1 BOTTLE (61919-046-15)	15 capsule	2014-01-01	0000-00-00	No	No	Current
61919-046-30	61919004630	30 CAPSULE in 1 BOTTLE (61919-046-30)	30 capsule	2014-01-01	0000-00-00	No	No	Current
61919-046-60	61919004660	60 CAPSULE in 1 BOTTLE (61919-046-60)	60 capsule	2014-01-01	0000-00-00	No	No	Current
61919-046-90	61919004690	90 CAPSULE in 1 BOTTLE (61919-046-90)	90 capsule	2014-01-01	0000-00-00	No	No	Current