Diclofenac Sodium

Product NDC
57896-147
11-digit product format
578960147
Labeler code
57896
Product ID
57896-147_7a3eb2ec-b80e-4482-98ba-e1d1a75844ea
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
GERI-CARE PHARMACEUTICAL CORP
Application
ANDA204306
Marketing category
ANDA
Marketing start
2023-08-11
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
57896-147-01578960147011 TUBE in 1 CARTON (57896-147-01) / 100 g in 1 TUBE1 tube2023-08-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac Sodium - GERI-CARE PHARMACEUTICAL CORP | Aurohealth LLC | APL HEALTHCARE LIMITEDGERI-CARE PHARMACEUTICAL CORP | Aurohealth LLC | APL HEALTHCARE LIMITED2025-04-21Human OTC Drug Label4