Diclofenac Sodium

Product NDC
53002-5361
11-digit product format
530025361
Labeler code
53002
Product ID
53002-5361_8b89d61e-35eb-402a-a977-43386fa099df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074514
Marketing category
ANDA
Marketing start
1996-03-26
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-5361-15300253610110 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5361-1) 2019-01-010000-00-00NoNoCurrent
53002-5361-25300253610220 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5361-2) 2019-01-010000-00-00NoNoCurrent
53002-5361-35300253610330 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5361-3) 2019-01-010000-00-00NoNoCurrent
53002-5361-55300253610515 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5361-5) 2019-01-010000-00-00NoNoCurrent