Diclofenac sodium

Product NDC
71085-003
11-digit product format
710850003
Labeler code
71085
Product ID
71085-003_c4f130b9-1e58-4e59-a01d-65cd423645a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
IPG PHARMACEUTICALS, INC.
Application
ANDA206298
Marketing category
ANDA
Marketing start
2016-04-28
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
30 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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71085-003-002025-12-29C16284748780-13b156c62-2e54-fb37-e063-e6dba90a4e07Diclofenac Sodium Gel, 3%
71085-003-002025-07-29C16284748780-13b156c62-2e54-fb37-e063-e6dba90a4e07Diclofenac Sodium Gel, 3%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-003-00GM - Gram71085-003bc4ded08-fc7a-45be-8b97-321f205420f712017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71085-003DICLOFENAC SODIUM GEL [IPG PHARMACEUTICALS, INC.]1Legacy NDC20170227_c73b0fd0-50b9-4262-bbef-5f71eef79036.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71085-003-00710850003001 TUBE in 1 CARTON (71085-003-00) > 100 g in 1 TUBE1 tube2016-12-220000-00-00NoNoCurrent