FDA.reportPublic FDA data

Diclofenac Sodium 1.5%

Product NDC
70512-038
11-digit product format
705120038
Labeler code
70512
Product ID
70512-038_457256fd-2abe-2c5a-e063-6394a90a84c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium Topical
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SOLA Pharmaceuticals
Application
ANDA204132
Marketing category
ANDA
Marketing start
2021-06-04
Substance
DICLOFENAC SODIUM
Active strength
16.05 mg/mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium 1.5%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM16.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui857700

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-038-05Diclofenac Sodium 1.5%150 mL in 1 BOTTLESOLUTION1506
70512-038-05Diclofenac Sodium 1.5%1 in 1 CARTONSOLUTION16
70512-038-05Profinac150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL1
70512-038-05Profinac1 in 1 CARTONSOLUTION16.05 mg in 1mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-038-05ML - Milliliter70512-038616dd2d3-b1a9-4c80-831e-f68246681aef12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-038DICLOFENAC SODIUM 1.5% (DICLOFENAC SODIUM TOPICAL) SOLUTION [SOLA PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240522_c3f33952-44a8-71b2-e053-2a95a90abda2.zip
70512-038PROFINAC (DICLOFENAC SODIUM) KIT [ASHOKA HEALTH]1Current NDC, Legacy NDC20220218_e1dce228-1b5b-4350-b1d1-c2960a9b4273.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNc3f33952-44a8-71b2-e053-2a95a90abda26
857700diclofenac sodium 15 MG/ML Topical SolutionSCDc3f33952-44a8-71b2-e053-2a95a90abda26
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYc3f33952-44a8-71b2-e053-2a95a90abda26
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYc3f33952-44a8-71b2-e053-2a95a90abda26
857700diclofenac sodium 1.5 % Topical SolutionPSNf18a4691-93a1-01e6-e053-2995a90a00694
857700diclofenac sodium 1.5 % Topical SolutionPSNa5b33bf7-8113-9c54-e053-2995a90a79d84
857700diclofenac sodium 15 MG/ML Topical SolutionSCDa5b33bf7-8113-9c54-e053-2995a90a79d84
857700diclofenac sodium 15 MG/ML Topical SolutionSCDf18a4691-93a1-01e6-e053-2995a90a00694
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYf18a4691-93a1-01e6-e053-2995a90a00694
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYa5b33bf7-8113-9c54-e053-2995a90a79d84
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYa5b33bf7-8113-9c54-e053-2995a90a79d84
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYf18a4691-93a1-01e6-e053-2995a90a00694
857700diclofenac sodium 1.5 % Topical SolutionPSN90b25b9b-3930-48af-b139-d24f2fccfcdc2
857700diclofenac sodium 1.5 % Topical SolutionPSN1f12948a-a52b-4a71-b555-edd98cc5a3732
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1f12948a-a52b-4a71-b555-edd98cc5a3732
857700diclofenac sodium 15 MG/ML Topical SolutionSCD90b25b9b-3930-48af-b139-d24f2fccfcdc2
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1f12948a-a52b-4a71-b555-edd98cc5a3732
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY90b25b9b-3930-48af-b139-d24f2fccfcdc2
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY90b25b9b-3930-48af-b139-d24f2fccfcdc2
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1f12948a-a52b-4a71-b555-edd98cc5a3732
857700diclofenac sodium 1.5 % Topical SolutionPSNe1dce228-1b5b-4350-b1d1-c2960a9b42731
857700diclofenac sodium 15 MG/ML Topical SolutionSCDe1dce228-1b5b-4350-b1d1-c2960a9b42731
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYe1dce228-1b5b-4350-b1d1-c2960a9b42731
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYe1dce228-1b5b-4350-b1d1-c2960a9b42731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70512-038-05705120038051 BOTTLE in 1 CARTON (70512-038-05) / 150 mL in 1 BOTTLE1 bottle2021-06-040000-00-00NoNoCurrent