Celecoxib

Product NDC
43353-257
11-digit product format
433530257
Labeler code
43353
Product ID
43353-257_e3381eee-5310-4f22-ae15-a059905f2c83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078857
Marketing category
ANDA
Marketing start
2015-11-09
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-257-30EA - Each43353-257cf295bd0-9869-43e1-88cc-26900a88548b12017-10-13
43353-257-53EA - Each43353-25739f9fc03-d645-4de4-a8b1-7a592232237d12017-10-13
43353-257-60EA - Each43353-257d41bc4ef-0dfd-4326-878c-ee85a7e60a3612017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-257CELECOXIB CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171003_c5f4c4bf-f665-4b07-825a-51cc0ffb1788.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-257-304335302573030 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-30) 30 capsule2016-11-150000-00-00NoNoCurrent
43353-257-534335302575360 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-53) 60 capsule2017-06-130000-00-00NoNoCurrent
43353-257-604335302576090 CAPSULE in 1 BOTTLE, PLASTIC (43353-257-60) 90 capsule2017-06-130000-00-00NoNoCurrent