CELECOXIB

Product NDC: 68071-2626
11-digit product format: 680712626
Labeler code: 68071
Product ID: 68071-2626_d61d3545-f90a-85c1-e053-2995a90aff61
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CELECOXIB
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA210628
Marketing category: ANDA
Marketing start: 2020-09-03
Marketing end: 0000-00-00
Substance: CELECOXIB
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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
68071-2626-3	2024-01-30	C162847	48780-1	1030e365-2374-111a-e063-dadaa90a10e2	HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2626-3	CELECOXIB	30 in 1 BOTTLE	CAPSULE	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2626	CELECOXIB CAPSULE [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220123_d61d3658-5138-4fba-e053-2995a90ae525.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	d61d3658-5138-4fba-e053-2995a90ae525	1
205323	celecoxib 200 MG Oral Capsule	SCD	d61d3658-5138-4fba-e053-2995a90ae525	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2626-3	68071262603	30 CAPSULE in 1 BOTTLE (68071-2626-3)	30 capsule	2022-01-21	0000-00-00	No	No	Current