Diclofenac Sodium

Product NDC
76420-134
11-digit product format
764200134
Labeler code
76420
Product ID
76420-134_b965985a-9568-58f3-e053-2995a90a008c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION/ DROPS
Route
TRANSDERMAL
Labeler
Asclemed USA, Inc.
Application
ANDA204132
Marketing category
ANDA
Marketing start
2015-08-20
Substance
DICLOFENAC SODIUM
Active strength
16.05 mg/mL
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
76420-134-0576420013405150 mL in 1 BOTTLE (76420-134-05) 150 ml2021-01-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac SodiumAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2021-01-21HUMAN PRESCRIPTION DRUG LABEL1