Celecoxib

Product NDC
0378-7160
11-digit product format
003787160
Labeler code
0378
Product ID
0378-7160_bf30a30a-9307-4319-a5c2-d0f59dfc546e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA078857
Marketing category
ANDA
Marketing start
2014-05-30
Marketing end
2023-02-28
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
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7160-01EA - Each0378-7160da09ce09-91e2-4757-a21f-6208f0aa052812016-01-13
0378-7160-05EA - Each0378-7160b5258cf5-6ba5-42b8-97a1-44db32e4af6612015-12-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7160-0100378716001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-7160-01) 100 capsule2014-05-300000-00-00NoNoCurrent
0378-7160-0500378716005500 CAPSULE in 1 BOTTLE, PLASTIC (0378-7160-05) 500 capsule2014-05-300000-00-00NoNoCurrent