Diclofenac Sodium 1.5%

Product NDC
68788-7701
11-digit product format
687887701
Labeler code
68788
Product ID
68788-7701_07070433-8f49-4870-975a-6c34051b5943
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical Solution
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202769
Marketing category
ANDA
Marketing start
2020-08-14
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
16 mg/mL
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7701-12022-02-16C16284748780-1d6a99b39-e113-a426-e053-dadaa90af4c200e44f77-170b-42d8-ae03-768d7c9f9c34
68788-7701-12022-01-28C16284748780-1d6a99b39-e113-a426-e053-dadaa90af4c200e44f77-170b-42d8-ae03-768d7c9f9c34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7701-1EA - Each68788-7701ccdd0de7-5725-4ca2-a751-7dff71920f0a12020-09-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7701-168788770101150 mL in 1 BOTTLE (68788-7701-1) 150 ml2020-08-140000-00-00NoNoCurrent