Diclofenac Sodium

Product NDC
55700-735
11-digit product format
557000735
Labeler code
55700
Product ID
55700-735_9cda37d7-14d0-451c-a980-f8872a90d465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Quality Care Products, LLC
Application
ANDA206116
Marketing category
ANDA
Marketing start
2019-03-22
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
16 mg/mL
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-735-15ML - Milliliter55700-7351db06651-c38c-42b3-b9c0-8ec3c8fc8bbb12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-735DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [QUALITY CARE PRODUCTS, LLC]4Legacy NDC20241220_27c3b050-ba58-47ca-9b8c-e04998b50bb3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-735-15557000735151 BOTTLE in 1 CARTON (55700-735-15) > 150 mL in 1 BOTTLE1 bottle2019-03-220000-00-00NoNoCurrent