Celecoxib

Product NDC
81288-021
11-digit product format
812880021
Labeler code
81288
Product ID
81288-021_9dca0e35-a3f7-499a-a256-ad4de9a78812
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
EMC PHARMA, LLC
Application
ANDA211412
Marketing category
ANDA
Marketing start
2022-07-18
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81288-021-20EA - Each81288-021441d4548-21c7-4167-80a9-d807700dd2d412022-10-06
81288-021-30EA - Each81288-021b42dfb07-0d78-4b11-bad7-a6d724eed4ca12022-10-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81288-021-2081288002120100 CAPSULE in 1 BOTTLE (81288-021-20) 100 capsule2022-07-180000-00-00NoNoCurrent
81288-021-3081288002130500 CAPSULE in 1 BOTTLE (81288-021-30) 500 capsule2022-07-180000-00-00NoNoCurrent