Diclofenac Sodium

Product NDC
55700-604
11-digit product format
557000604
Labeler code
55700
Product ID
55700-604_7e5d5fa9-5e51-4ea6-a9a8-05765862ca49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA076152
Marketing category
ANDA
Marketing start
2018-04-13
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
100 mg/1
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-604-30EA - Each55700-604f29b246f-7078-4698-a057-faf8d388516412018-05-09
55700-604-60EA - Each55700-604a5114711-f45c-4f8b-ac7e-2f43290412c512018-05-09