Diclofenac Sodium

Product NDC
68788-6388
11-digit product format
687886388
Labeler code
68788
Product ID
68788-6388_490b4c79-a3e2-4587-a0c0-8f78d524c90a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075492
Marketing category
ANDA
Marketing start
2016-05-05
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
100 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-6388-168788638801100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-6388-1) 2016-05-050000-00-00NoNoCurrent
68788-6388-36878863880330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-6388-3) 2016-05-050000-00-00NoNoCurrent
68788-6388-66878863880660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-6388-6) 2016-05-050000-00-00NoNoCurrent
68788-6388-868788638808120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-6388-8) 2016-05-050000-00-00NoNoCurrent
68788-6388-96878863880990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-6388-9) 2016-05-050000-00-00NoNoCurrent