FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
52565-002
11-digit product format
525650002
Labeler code
52565
Product ID
52565-002_ae10fced-afa2-4c84-808d-54e581c3ecee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA202769
Marketing category
ANDA
Marketing start
2018-07-31
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
2022-12-31
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
52565-002-052023-07-28C16284748780-10191ceaa-70bb-198a-e063-dbdaa90aec3eThese 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, USP 1.5% w/w, for topical use Initial U.S. Approval: 1988
52565-002-592023-07-28C16284748780-10191ceaa-70bb-198a-e063-dbdaa90aec3eThese 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, USP 1.5% w/w, for topical use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-002-05Diclofenac Sodium1 in 1 CARTONSOLUTION19
52565-002-05Diclofenac Sodium150 mL in 1 BOTTLESOLUTION1509
52565-002-59Diclofenac Sodium1 in 1 CARTONSOLUTION19
52565-002-59Diclofenac Sodium60 mL in 1 BOTTLESOLUTION609
52565-002-05Diclovix M150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-002-05ML - Milliliter52565-0023b9f0491-bdbd-4074-800b-83a1e6f2cb3f12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [TELIGENT PHARMA, INC.]3
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [TELIGENT PHARMA, INC.]3
alcoholINACTIVE INGREDIENT3K9958V90MDICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [TELIGENT PHARMA, INC.]3
dimethyl sulfoxideINACTIVE INGREDIENTYOW8V9698HDICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [TELIGENT PHARMA, INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXDICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [TELIGENT PHARMA, INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [TELIGENT PHARMA, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [TELIGENT PHARMA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-002DICLOFENAC SODIUM SOLUTION [TELIGENT PHARMA, INC.]9Legacy NDC, 4 package rows20210603_5960adae-9ed2-469a-b092-ac977d260222.zip
52565-002DICLOVIX M (DICLOFENAC SODIUM, WITH CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE PATCH) KIT [PRIMARY PHARMACEUTICALS, INC]1Legacy NDC20200126_9d0012ed-a50a-a936-e053-2995a90a6100.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN5960adae-9ed2-469a-b092-ac977d2602229
857700diclofenac sodium 15 MG/ML Topical SolutionSCD5960adae-9ed2-469a-b092-ac977d2602229
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY5960adae-9ed2-469a-b092-ac977d2602229
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY5960adae-9ed2-469a-b092-ac977d2602229
2119857ActivICE 8 % Topical GelPSN9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 1.5 % Topical SolutionPSN7bc185e2-e749-4a24-8550-c2f6d39222d21
857700diclofenac sodium 1.5 % Topical SolutionPSN9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 1.5 % Topical SolutionPSN8c0327d4-c0f3-418d-abbe-bf0007e063231
283257menthol 8 % Topical GelPSN9d0012ed-a50a-a936-e053-2995a90a61001
2119857menthol 0.08 MG/MG Topical Gel [ActivICE]SBD9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 15 MG/ML Topical SolutionSCD7bc185e2-e749-4a24-8550-c2f6d39222d21
857700diclofenac sodium 15 MG/ML Topical SolutionSCD9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 15 MG/ML Topical SolutionSCD8c0327d4-c0f3-418d-abbe-bf0007e063231
283257menthol 0.08 MG/MG Topical GelSCD9d0012ed-a50a-a936-e053-2995a90a61001
2119857ActivICE 0.08 MG/MG Topical GelSY9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY8c0327d4-c0f3-418d-abbe-bf0007e063231
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY9d0012ed-a50a-a936-e053-2995a90a61001
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY7bc185e2-e749-4a24-8550-c2f6d39222d21
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY8c0327d4-c0f3-418d-abbe-bf0007e063231
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY7bc185e2-e749-4a24-8550-c2f6d39222d21
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY9d0012ed-a50a-a936-e053-2995a90a61001
283257menthol 8 % Topical GelSY9d0012ed-a50a-a936-e053-2995a90a61001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-002-05525650002051 BOTTLE in 1 CARTON (52565-002-05) > 150 mL in 1 BOTTLE1 bottle2018-07-310000-00-00NoNoCurrent
52565-002-59525650002591 BOTTLE in 1 CARTON (52565-002-59) > 60 mL in 1 BOTTLE1 bottle2018-07-310000-00-00NoNoCurrent