Celecoxib

Product NDC
0378-7165
11-digit product format
003787165
Labeler code
0378
Product ID
0378-7165_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
2023-06-30
Substance
CELECOXIB
Active strength
50 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
0378-7165-01EA - Each0378-71653d8cf326-de56-4943-a816-6b2cb9e9e09312015-05-05
0378-7165-91EA - Each0378-71651744ffe8-95d1-424d-9438-5c4e2113715012015-07-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7165-910037871659160 CAPSULE in 1 BOTTLE, PLASTIC (0378-7165-91) 60 capsule2014-05-300000-00-00NoNoCurrent