FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
71335-0648
11-digit product format
713350648
Labeler code
71335
Product ID
71335-0648_cfa0cb80-a307-440c-99c4-88576c0c8bdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
71335-0648-1Diclofenac Sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE606
71335-0648-2Diclofenac Sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306
71335-0648-3Diclofenac Sodium15 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE156
71335-0648-4Diclofenac Sodium14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE146
71335-0648-5Diclofenac Sodium10 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE106
71335-0648-6Diclofenac Sodium21 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE216
71335-0648-7Diclofenac Sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE906
71335-0648-8Diclofenac Sodium120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1206
71335-0648-9Diclofenac Sodium7 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE76

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0648-1EA - Each71335-06486a114c70-83f6-45e1-bf89-209b82b8f92d12018-09-05
71335-0648-2EA - Each71335-0648ad053f86-384e-4c2c-b653-4a68fdd921df12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0648DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 9 package rows20250221_49013aad-475c-4efb-84c6-15a5d4664fbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSN49013aad-475c-4efb-84c6-15a5d4664fbf6
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCD49013aad-475c-4efb-84c6-15a5d4664fbf6
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSY49013aad-475c-4efb-84c6-15a5d4664fbf6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0648-17133506480160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-1) 2018-05-220000-00-00NoNoCurrent
71335-0648-27133506480230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-2) 2018-04-130000-00-00NoNoCurrent
71335-0648-37133506480315 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-3) 2025-01-290000-00-00NoNoCurrent
71335-0648-47133506480414 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-4) 2018-07-230000-00-00NoNoCurrent
71335-0648-57133506480510 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-5) 2022-10-130000-00-00NoNoCurrent
71335-0648-67133506480621 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-6) 2018-07-030000-00-00NoNoCurrent
71335-0648-77133506480790 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-7) 2019-04-160000-00-00NoNoCurrent
71335-0648-871335064808120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-8) 2025-01-290000-00-00NoNoCurrent
71335-0648-9713350648097 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-9) 2025-01-29NoNoHistorical