Diclofenac Sodium

Product NDC
58602-603
11-digit product format
586020603
Labeler code
58602
Product ID
58602-603_a95a203b-13fa-4185-9c2a-e9048a4bda64
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac
Dosage form
GEL
Route
TOPICAL
Labeler
Aurohealth LLC
Application
ANDA204306
Marketing category
ANDA
Marketing start
2022-03-07
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58602-603-072023-11-22C16284748780-10191ceaa-6ad4-198a-e063-dbdaa90aec3ea95a203b-13fa-4185-9c2a-e9048a4bda64
58602-603-072023-07-28C16284748780-10191ceaa-6ad4-198a-e063-dbdaa90aec3ea95a203b-13fa-4185-9c2a-e9048a4bda64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-603-07586020603071 TUBE in 1 CARTON (58602-603-07) > 100 g in 1 TUBE1 tube2022-03-070000-00-00NoNoCurrent