DICLOFENAC SODIUM

Product NDC
82804-052
11-digit product format
828040052
Labeler code
82804
Product ID
82804-052_f19bf286-f4dd-4491-90c3-9f8713071903
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA208301
Marketing category
ANDA
Marketing start
2016-09-13
Substance
DICLOFENAC SODIUM
Active strength
30 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
82804-052-00828040052001 TUBE in 1 CARTON (82804-052-00) / 100 g in 1 TUBE1 tube2023-12-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DICLOFENAC SODIUMProficient Rx LP2023-12-01HUMAN PRESCRIPTION DRUG LABEL1