Diclofenac Sodium

Product NDC
46122-711
11-digit product format
461220711
Labeler code
46122
Product ID
46122-711_11e975a3-d93b-4f60-91b7-826bee8e47c6
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac
Dosage form
GEL
Route
TOPICAL
Labeler
Amerisource Bergen
Application
ANDA204306
Marketing category
ANDA
Marketing start
2022-06-27
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
46122-711-542023-11-22C16284748780-10191ceaa-698d-198a-e063-dbdaa90aec3e11e975a3-d93b-4f60-91b7-826bee8e47c6
46122-711-542023-07-28C16284748780-10191ceaa-698d-198a-e063-dbdaa90aec3e11e975a3-d93b-4f60-91b7-826bee8e47c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-711-54461220711541 TUBE in 1 CARTON (46122-711-54) > 100 g in 1 TUBE1 tube2022-06-270000-00-00NoNoCurrent