Diclofenac sodium

Product NDC
55700-980
11-digit product format
557000980
Labeler code
55700
Product ID
55700-980_c809c81f-d7c7-4bc1-8c08-b5905afa97d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Quality Care Products, LLC
Application
ANDA206298
Marketing category
ANDA
Marketing start
2022-07-21
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-980-00557000980001 TUBE in 1 CARTON (55700-980-00) > 100 g in 1 TUBE1 tube2022-07-210000-00-00NoNoCurrent