Diclofenac Sodium

Product NDC
50090-7838
11-digit product format
500907838
Labeler code
50090
Product ID
50090-7838_8a5992ce-44cc-460a-970e-4d7b5ac068e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075185
Marketing category
ANDA
Marketing start
2025-03-28
Substance
DICLOFENAC SODIUM
Active strength
75 mg/1
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 formatDescriptionMarketing startSampleExclude flagStatus
50090-7838-050090783800100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-0) 2025-12-29NoNoHistorical
50090-7838-15009078380120 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-1) 2025-12-29NoNoHistorical
50090-7838-25009078380230 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-2) 2025-12-29NoNoHistorical
50090-7838-35009078380314 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-3) 2025-12-29NoNoHistorical
50090-7838-45009078380460 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-4) 2025-12-29NoNoHistorical
50090-7838-85009078380890 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-8) 2025-12-29NoNoHistorical
50090-7838-950090783809180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-9) 2025-12-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac SodiumA-S Medication Solutions2025-12-30HUMAN PRESCRIPTION DRUG LABEL1