Diclofenac Sodium Topical Solution

Product NDC
72189-546
11-digit product format
721890546
Labeler code
72189
Product ID
72189-546_15c2cd6d-b7c3-d927-e063-6394a90aa63e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical Solution
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Direct_Rx
Application
ANDA213040
Marketing category
ANDA
Marketing start
2024-04-10
Substance
DICLOFENAC SODIUM
Active strength
20 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
QTG126297QDICLOFENAC SODIUM15307-79-6DICLOFENAC SODIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-546-0472189054604112 g in 1 BOTTLE (72189-546-04) 112 g2024-04-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac Sodium Topical SolutionDirect_Rx2024-04-10HUMAN PRESCRIPTION DRUG LABEL1