FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
53149-4902
11-digit product format
531494902
Labeler code
53149
Product ID
53149-4902_b13d20a0-fd57-4427-a925-fee62e2d997e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac
Dosage form
SOLUTION
Route
TOPICAL
Labeler
All Pharma, LLC
Application
ANDA206116
Marketing category
ANDA
Marketing start
2016-09-02
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
53149-4902-12022-01-28C16284748780-1d6a99b39-520a-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution 1.5% w/w, for topical use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-4902-1Diclofenac Sodium1 in 1 CARTONSOLUTION15
53149-4902-1Diclofenac Sodium150 mL in 1 BOTTLESOLUTION1505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53149-4902-1ML - Milliliter53149-4902333e8c24-e011-4517-848e-ef460f1aa1ea12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-4902DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [ALL PHARMA, LLC]5Legacy NDC, 2 package rows20200120_26a58eef-f968-4781-93eb-0b3c71825f45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN26a58eef-f968-4781-93eb-0b3c71825f455
857700diclofenac sodium 15 MG/ML Topical SolutionSCD26a58eef-f968-4781-93eb-0b3c71825f455
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY26a58eef-f968-4781-93eb-0b3c71825f455
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY26a58eef-f968-4781-93eb-0b3c71825f455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53149-4902-1531494902011 BOTTLE in 1 CARTON (53149-4902-1) > 150 mL in 1 BOTTLE1 bottle2018-09-060000-00-00NoNoCurrent