FDA.reportPublic FDA data

berkley and jensen arthritis pain

Product NDC
68391-205
11-digit product format
683910205
Labeler code
68391
Product ID
68391-205_f8497dc3-9d28-4ad9-8770-eb36ed0563cb
Type
HUMAN OTC DRUG
Nonproprietary name
diclofenac sodium
Dosage form
KIT
Labeler
BJWC
Application
ANDA211253
Marketing category
ANDA
Marketing start
2021-11-10
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
berkley and jensen arthritis pain
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui855633

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
68391-205-00berkley and jensen arthritis pain1 in 1 PACKAGEKIT13
68391-871-00berkley and jensen arthritis pain2 in 1 CARTONGEL10 mg in 1g3
68391-871-02berkley and jensen arthritis pain1 in 1 CARTONGEL10 mg in 1g3
68391-871-02berkley and jensen arthritis pain50 g in 1 TUBEGEL50 g10 mg in 1g3
68391-871-03berkley and jensen arthritis pain150 g in 1 TUBEGEL300 g10 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-205BERKLEY AND JENSEN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [BJWC]3Current NDC, Legacy NDC, 5 package rows20231130_441cf367-b293-47e8-a8fb-32e3314be7de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN441cf367-b293-47e8-a8fb-32e3314be7de3
855633diclofenac sodium 0.01 MG/MG Topical GelSCD441cf367-b293-47e8-a8fb-32e3314be7de3
855633diclofenac sodium 1 % Topical GelSY441cf367-b293-47e8-a8fb-32e3314be7de3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-205-00683910205001 KIT in 1 PACKAGE (68391-205-00) * 1 TUBE in 1 CARTON (68391-871-02) / 50 g in 1 TUBE * 2 TUBE in 1 CARTON (68391-871-00) / 150 g in 1 TUBE (68391-871-03) 1 kit2021-11-100000-00-00NoNoCurrent
68391-871-00683910871002 in 1 CARTONHistorical
68391-871-02683910871021 in 1 CARTONHistorical
68391-871-0368391087103150 g in 1 TUBE150 gHistorical