Diclofenac Sodium

Product NDC
63187-822
11-digit product format
631870822
Labeler code
63187
Product ID
63187-822_2e24c976-daee-435d-8e1a-ae8297b26ad5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074394
Marketing category
ANDA
Marketing start
1995-11-30
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
75 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],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
63187-822-15EA - Each63187-822461fba05-0c35-4e13-97a0-23b83c42165012017-04-05
63187-822-30EA - Each63187-82285d379ac-ffe3-4e40-a931-826a707424be12017-06-15
63187-822-60EA - Each63187-822299eaa76-2403-40b8-be7e-d48578436d9812017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-822DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]2Legacy NDC20191113_c1446ba4-82e8-4f5e-9f1e-c8a75dd536c7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-822-156318708221515 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-822-15) 1995-11-300000-00-00NoNoCurrent
63187-822-206318708222020 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-822-20) 1995-11-300000-00-00NoNoCurrent
63187-822-306318708223030 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-822-30) 1995-11-300000-00-00NoNoCurrent
63187-822-606318708226060 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-822-60) 1995-11-300000-00-00NoNoCurrent