DICLOFENAC SODIUM

Product NDC
55700-511
11-digit product format
557000511
Labeler code
55700
Product ID
55700-511_eae830f1-c824-4135-87e5-7601a6237e10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA208301
Marketing category
ANDA
Marketing start
2016-09-13
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
30 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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-511-002025-01-09C16284748780-11030e365-0588-111a-e063-dadaa90a10e260c0e86c-dcff-4d31-a456-5fc17b502ed1
55700-511-002024-01-30C16284748780-11030e365-0588-111a-e063-dadaa90a10e260c0e86c-dcff-4d31-a456-5fc17b502ed1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-511-00GM - Gram55700-511a5f2e106-09ea-4ae9-a402-e36fec74b0d012017-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-511-00557000511001 TUBE in 1 CARTON (55700-511-00) > 100 g in 1 TUBE1 tube2016-09-130000-00-00NoNoCurrent