Diclofenac Sodium 1.5%

Product NDC
55700-878
11-digit product format
557000878
Labeler code
55700
Product ID
55700-878_c1710b8d-f9de-405f-b495-0042077892e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical Solution
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Quality Care Products, LLC
Application
ANDA202769
Marketing category
ANDA
Marketing start
2020-08-25
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-878-15ML - Milliliter55700-87883b59497-1e4e-4671-b1dc-b2773ec97eab12021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-878-1555700087815150 mL in 1 BOTTLE (55700-878-15) 150 ml2020-08-250000-00-00NoNoCurrent