FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
61919-343
11-digit product format
619190343
Labeler code
61919
Product ID
61919-343_9c93a960-4afa-5105-e053-2a95a90a90b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC SODIUM
Dosage form
SOLUTION
Route
TOPICAL
Labeler
DIRECT RX
Application
ANDA202027
Marketing category
ANDA
Marketing start
2017-10-31
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
2021-12-31
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
61919-343-052023-01-30C16284748780-1f386c64a-3b19-0266-e053-dadaa90a7c1aDICLOFENAC SODIUM TOPICAL SOLUTION 1.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-343-05DICLOFENAC SODIUM150 mL in 1 CARTONSOLUTION1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-343-05ML - Milliliter61919-343d8e0ca41-9c9e-48fa-a5f4-f8c43ab7cffd12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-343DICLOFENAC SODIUM SOLUTION [DIRECT RX]2Legacy NDC, 1 package rows20200121_5cd96e45-e027-3c9a-e053-2a91aa0a807e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN5cd96e45-e027-3c9a-e053-2a91aa0a807e2
857700diclofenac sodium 15 MG/ML Topical SolutionSCD5cd96e45-e027-3c9a-e053-2a91aa0a807e2
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY5cd96e45-e027-3c9a-e053-2a91aa0a807e2
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY5cd96e45-e027-3c9a-e053-2a91aa0a807e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-343-0561919034305150 mL in 1 CARTON (61919-343-05) 150 ml2017-10-310000-00-00NoNoCurrent