Celecoxib 400 mg

Product NDC: 69399-185
11-digit product format: 693990185
Labeler code: 69399
Product ID: 69399-185_693a271d-9908-4fdc-bccf-15465bdd8b02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CELECOXIB
Dosage form: CAPSULE
Route: ORAL
Labeler: SYDON LABS LLC
Application: ANDA204519
Marketing category: ANDA
Marketing start: 2015-11-24
Marketing end: 0000-00-00
Substance: CELECOXIB
Active strength: 400 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
69399-185-81	2020-01-31	C162847	48780-1	9d75b9d0-7f6c-f424-e053-dadaa90a57ce	Celecoxib 400 mg These highlights do not include all the information needed to use celecoxib safely and effectively. See full prescribing information for Celecoxib. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69399-185-81	Celecoxib 400 mg	100 in 1 BOTTLE	CAPSULE	100		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69399-185-81	EA - Each	69399-185	807c8e53-cddc-441d-bc5e-b7dfc8010a5d	1	2016-01-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69399-185	CELECOXIB 400 MG (CELECOXIB) CAPSULE [SYDON LABS LLC]	1	Legacy NDC, 1 package rows	20151208_a2d75d7d-a6d0-4489-85f7-a57c237ba5e2.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
349514	celecoxib 400 MG Oral Capsule	PSN	a2d75d7d-a6d0-4489-85f7-a57c237ba5e2	1
349514	celecoxib 400 MG Oral Capsule	SCD	a2d75d7d-a6d0-4489-85f7-a57c237ba5e2	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69399-185-81	69399018581	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib 400 mg	SYDON LABS LLC \| Alembic Pharmaceuticals Limited	2015-11-27	HUMAN PRESCRIPTION DRUG LABEL	1