FDA.reportPublic FDA data

DICLOFENAC SODIUM

Product NDC
69837-399
11-digit product format
698370399
Labeler code
69837
Product ID
69837-399_64428c78-3a2b-4e81-a1a2-b411c485ebe3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOFENAC SODIUM
Dosage form
SOLUTION
Route
TOPICAL
Labeler
International Brand Management, LLC
Application
ANDA202027
Marketing category
ANDA
Marketing start
2016-02-04
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
E
Listing certified through
2017-12-31
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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
69837-399-052020-01-31C16284748780-19d75b9d0-fb5f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69837-399-05Sure Result DSS Premium Pak150 mL in 1 TUBESOLUTION150 mL16.05 mg in 1mL4
69837-399-05Sure Result DSS Premium Pak1 in 1 KITSOLUTION16.05 mg in 1mL4
69837-399-05DICLOFENAC SODIUM150 mL in 1 TUBESOLUTION1501
69837-399-05DICLOFENAC SODIUM1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69837-399-05ML - Milliliter69837-39932089547-82e1-429b-aaef-0d52d1052afb12016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69837-399SURE RESULT DSS PREMIUM PAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]4Legacy NDC20160804_ee2743ed-8002-435b-bbbc-ea8824880f62.zip
69837-399DICLOFENAC SODIUM SOLUTION [INTERNATIONAL BRAND MANAGEMENT, LLC]1Legacy NDC, 2 package rows20160208_aca9ebff-a437-48d9-8baf-06b9021a4740.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNee2743ed-8002-435b-bbbc-ea8824880f624
857700diclofenac sodium 15 MG/ML Topical SolutionSCDee2743ed-8002-435b-bbbc-ea8824880f624
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYee2743ed-8002-435b-bbbc-ea8824880f624
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYee2743ed-8002-435b-bbbc-ea8824880f624
857700diclofenac sodium 1.5 % Topical SolutionPSNaca9ebff-a437-48d9-8baf-06b9021a47401
857700diclofenac sodium 15 MG/ML Topical SolutionSCDaca9ebff-a437-48d9-8baf-06b9021a47401
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYaca9ebff-a437-48d9-8baf-06b9021a47401
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYaca9ebff-a437-48d9-8baf-06b9021a47401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69837-399-0569837039905150 mL in 1 TUBE150 mlHistorical