Diclofenac Sodium

Product NDC
63187-994
11-digit product format
631870994
Labeler code
63187
Product ID
63187-994_f65ac1f3-6065-44e4-ae2b-da5e52c81157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075492
Marketing category
ANDA
Marketing start
2000-02-28
Substance
DICLOFENAC SODIUM
Active strength
100 mg/1
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855657

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
63187-994-15Diclofenac Sodium15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE154
63187-994-20Diclofenac Sodium20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE204
63187-994-30Diclofenac Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
63187-994-60Diclofenac Sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604
63187-994-90Diclofenac Sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-994-30EA - Each63187-994090cf2ed-1d83-440a-a7c6-f66da34095b712018-08-13
63187-994-60EA - Each63187-9949939c3b2-78ed-4b64-9adc-74ae7c9699fd12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-994DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20250221_d70fcd8e-a72b-41ef-ac26-e0f2f279f062.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNd70fcd8e-a72b-41ef-ac26-e0f2f279f0624
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDd70fcd8e-a72b-41ef-ac26-e0f2f279f0624
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYd70fcd8e-a72b-41ef-ac26-e0f2f279f0624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-994-156318709941515 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-15) 2018-03-010000-00-00NoNoCurrent
63187-994-206318709942020 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-20) 2018-03-010000-00-00NoNoCurrent
63187-994-306318709943030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-30) 2018-03-010000-00-00NoNoCurrent
63187-994-606318709946060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-60) 2018-03-010000-00-00NoNoCurrent
63187-994-906318709949090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-90) 2018-03-010000-00-00NoNoCurrent