celecoxib

Product NDC: 55700-613
11-digit product format: 557000613
Labeler code: 55700
Product ID: 55700-613_52d20bdb-15ee-4058-81cb-be3f0f1ddfc3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Quality Care Products LLC
Application: ANDA204590
Marketing category: ANDA
Marketing start: 2018-05-04
Marketing end: 2026-12-31
Substance: CELECOXIB
Active strength: 100 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	100 mg/1

Field, Values table
Field	Values
Unii	JCX84Q7J1L
Rxcui	205322

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55700-613-30	celecoxib	30 in 1 BOTTLE	CAPSULE	30		7
55700-613-60	celecoxib	60 in 1 BOTTLE	CAPSULE	60		7

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-613-30	EA - Each	55700-613	77f32146-7389-4682-8536-17c22df3e54c	1	2018-06-11
55700-613-60	EA - Each	55700-613	d72fe023-86b6-412c-8739-0c58ea2f9045	1	2018-06-11

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-613	CELECOXIB CAPSULE [QUALITY CARE PRODUCTS LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250101_f0df546e-17c9-4e85-839d-336612d7b9e5.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
205322	celecoxib 100 MG Oral Capsule	PSN	f0df546e-17c9-4e85-839d-336612d7b9e5	7
205322	celecoxib 100 MG Oral Capsule	SCD	f0df546e-17c9-4e85-839d-336612d7b9e5	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-613-30	55700061330	30 CAPSULE in 1 BOTTLE (55700-613-30)	30 capsule	2018-05-04	2026-12-31	No	No	Current
55700-613-60	55700061360	60 CAPSULE in 1 BOTTLE (55700-613-60)	60 capsule	2018-05-04	2026-12-31	No	No	Current