FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
61919-675
11-digit product format
619190675
Labeler code
61919
Product ID
61919-675_94e0cb71-8733-d8a5-e053-2995a90a6792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC SODIUM
Dosage form
SOLUTION
Route
TOPICAL
Labeler
DIRECT RX
Application
ANDA202769
Marketing category
ANDA
Marketing start
2019-04-04
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-675-052023-01-30C16284748780-1f386c649-9ce8-0266-e053-dadaa90a7c1aDICLOFENAC SODIUM TOPICAL SOLUTION
61919-675-332023-01-30C16284748780-1f386c649-9ce8-0266-e053-dadaa90a7c1aDICLOFENAC SODIUM TOPICAL SOLUTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-675-05DICLOFENAC SODIUM1 mL in 1 BOTTLESOLUTION13
61919-675-33DICLOFENAC SODIUM150 mL in 1 BOTTLESOLUTION1503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-675-05ML - Milliliter61919-675f5803336-5420-4a90-b5b7-8ca54f74a73a12019-11-12
61919-675-33ML - Milliliter61919-675a9922ac7-25db-4067-b047-78cb2e9174b712019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-675DICLOFENAC SODIUM SOLUTION/ DROPS DICLOFENAC SODIUM SOLUTION [DIRECT RX]3Legacy NDC, 2 package rows20191015_3d976518-60d2-478a-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN3d976518-60d2-478a-e054-00144ff88e883
857700diclofenac sodium 15 MG/ML Topical SolutionSCD3d976518-60d2-478a-e054-00144ff88e883
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY3d976518-60d2-478a-e054-00144ff88e883
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY3d976518-60d2-478a-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-675-05619190675051 mL in 1 BOTTLE (61919-675-05) 1 ml2019-04-040000-00-00NoNoCurrent
61919-675-3361919067533150 mL in 1 BOTTLE (61919-675-33) 150 ml2019-04-040000-00-00NoNoCurrent