Diclofenac Sodium

Product NDC
63629-2012
11-digit product format
636292012
Labeler code
63629
Product ID
63629-2012_9f005ea7-9f4a-4c7f-8e21-74de2dc49ece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
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
63629-2012-16362920120112 BOTTLE, PLASTIC in 1 BOX (63629-2012-1) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC1998-11-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac SodiumBryant Ranch Prepack2024-01-09HUMAN PRESCRIPTION DRUG LABEL102