Diclofenac Sodium

Product NDC
71205-552
11-digit product format
712050552
Labeler code
71205
Product ID
71205-552_7e98952e-9b95-4296-9c23-c0ff4b82b2b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical Gel, 1%,
Dosage form
GEL
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA210986
Marketing category
ANDA
Marketing start
2020-01-30
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
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
71205-552-00712050552001 TUBE in 1 CARTON (71205-552-00) / 100 g in 1 TUBE1 tube2021-04-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac Sodium Topical Gel, 1%,Proficient Rx LP2021-04-01HUMAN PRESCRIPTION DRUG LABEL1