Diclofenac Sodium

Product NDC
58602-602
11-digit product format
586020602
Labeler code
58602
Product ID
58602-602_49961909-3aca-40b3-8424-668c1791c01d
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
58602-602-072023-11-22C16284748780-10191ceaa-6b2a-198a-e063-dbdaa90aec3e49961909-3aca-40b3-8424-668c1791c01d
58602-602-072023-07-28C16284748780-10191ceaa-6b2a-198a-e063-dbdaa90aec3e49961909-3aca-40b3-8424-668c1791c01d

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-602-07586020602071 TUBE in 1 CARTON (58602-602-07) > 100 g in 1 TUBE1 tube2022-03-070000-00-00NoNoCurrent