Diclofenac sodium

Product NDC
42291-256
11-digit product format
422910256
Labeler code
42291
Product ID
42291-256_d57a808f-0044-5d84-e053-2995a90a74ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac
Dosage form
GEL
Route
TOPICAL
Labeler
AvKARE
Application
ANDA208077
Marketing category
ANDA
Marketing start
2016-08-31
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-256-11GM - Gram42291-2560fc0fade-e202-42ad-951c-ccefe1ab390b12016-10-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-256-11422910256111 TUBE in 1 CARTON (42291-256-11) > 100 g in 1 TUBE1 tube2016-08-310000-00-00NoNoCurrent