FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
71335-1238
11-digit product format
713351238
Labeler code
71335
Product ID
71335-1238_72d96aa7-bd3d-44e0-98cf-b65a738221d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076201
Marketing category
ANDA
Marketing start
2002-11-06
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
71335-1238-1Diclofenac Sodium60 in 1 BOTTLETABLET, EXTENDED RELEASE605
71335-1238-2Diclofenac Sodium30 in 1 BOTTLETABLET, EXTENDED RELEASE305
71335-1238-3Diclofenac Sodium15 in 1 BOTTLETABLET, EXTENDED RELEASE155
71335-1238-4Diclofenac Sodium14 in 1 BOTTLETABLET, EXTENDED RELEASE145
71335-1238-5Diclofenac Sodium10 in 1 BOTTLETABLET, EXTENDED RELEASE105
71335-1238-6Diclofenac Sodium21 in 1 BOTTLETABLET, EXTENDED RELEASE215
71335-1238-7Diclofenac Sodium90 in 1 BOTTLETABLET, EXTENDED RELEASE905
71335-1238-8Diclofenac Sodium120 in 1 BOTTLETABLET, EXTENDED RELEASE1205
71335-1238-9Diclofenac Sodium7 in 1 BOTTLETABLET, EXTENDED RELEASE75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1238-1EA - Each71335-12385a3c9457-cfc0-458b-b007-0392d1ef0dea12019-11-12
71335-1238-2EA - Each71335-123841d8792e-83ba-4cd8-a074-a9f7832aaab612023-12-05
71335-1238-4EA - Each71335-123810e03210-f8bb-4b12-af7c-ba4528cfbd0c12023-12-05
71335-1238-5EA - Each71335-123869e6c5a4-7172-4e6e-b1bc-cc123fb56a0d12023-12-05
71335-1238-6EA - Each71335-12380492b843-12ec-492a-8e93-29104003423412020-09-14
71335-1238-9EA - Each71335-1238094e29d9-ad19-44a7-b33f-74c00d4d720b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1238DICLOFENAC SODIUM TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 9 package rows20231108_e9ece848-3cd3-4a75-be88-d131775016a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNe9ece848-3cd3-4a75-be88-d131775016a75
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDe9ece848-3cd3-4a75-be88-d131775016a75
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYe9ece848-3cd3-4a75-be88-d131775016a75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1238-17133512380160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-1) 2019-06-030000-00-00NoNoCurrent
71335-1238-27133512380230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-2) 2021-04-280000-00-00NoNoCurrent
71335-1238-37133512380315 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-3) 2022-06-290000-00-00NoNoCurrent
71335-1238-47133512380414 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-4) 2021-07-120000-00-00NoNoCurrent
71335-1238-57133512380510 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-5) 2021-08-300000-00-00NoNoCurrent
71335-1238-67133512380621 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-6) 2019-09-030000-00-00NoNoCurrent
71335-1238-77133512380790 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-7) 2022-06-290000-00-00NoNoCurrent
71335-1238-871335123808120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-8) 2022-06-290000-00-00NoNoCurrent
71335-1238-9713351238097 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1238-9) 2022-05-270000-00-00NoNoCurrent