FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
71335-9665
11-digit product format
713359665
Labeler code
71335
Product ID
71335-9665_744e72d3-6d43-47d1-9dff-47f4b833e6f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216275
Marketing category
ANDA
Marketing start
2022-09-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac sodium
Listing expiration
2027-12-31

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
71335-9665-0Diclofenac sodium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED100105
71335-9665-1Diclofenac sodium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED60105
71335-9665-2Diclofenac sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED30105
71335-9665-3Diclofenac sodium15 in 1 BOTTLE, PLASTICTABLET, FILM COATED15105
71335-9665-4Diclofenac sodium14 in 1 BOTTLE, PLASTICTABLET, FILM COATED14105
71335-9665-5Diclofenac sodium10 in 1 BOTTLE, PLASTICTABLET, FILM COATED10105
71335-9665-6Diclofenac sodium21 in 1 BOTTLE, PLASTICTABLET, FILM COATED21105
71335-9665-7Diclofenac sodium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED90105
71335-9665-8Diclofenac sodium120 in 1 BOTTLE, PLASTICTABLET, FILM COATED120105
71335-9665-9Diclofenac sodium7 in 1 BOTTLE, PLASTICTABLET, FILM COATED7105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9665-1EA - Each71335-96651fb02b2c-dd2b-44ed-bee8-56a9207c9f0e12023-12-05
71335-9665-2EA - Each71335-96654e388441-3cce-4adc-a4a0-42136c5685c612023-12-05
71335-9665-4EA - Each71335-966502921d6e-4f65-49e6-99f1-e16a1444ae6f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9665DICLOFENAC SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, 10 package rows20241122_b28e4a68-f396-4c1a-ba38-6a972906b4d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855657diclofenac sodium 100 MG 24HR Extended Release Oral TabletPSNb28e4a68-f396-4c1a-ba38-6a972906b4d0105
85565724 HR diclofenac sodium 100 MG Extended Release Oral TabletSCDb28e4a68-f396-4c1a-ba38-6a972906b4d0105
855657diclofenac sodium 100 MG 24 HR Extended Release Oral TabletSYb28e4a68-f396-4c1a-ba38-6a972906b4d0105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9665-071335966500100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-0) 2026-04-13NoNoHistorical
71335-9665-17133596650160 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-1) 2023-03-22NoNoHistorical
71335-9665-27133596650230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-2) 2023-03-23NoNoHistorical
71335-9665-37133596650315 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-3) 2026-04-13NoNoHistorical
71335-9665-47133596650414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-4) 2023-03-20NoNoHistorical
71335-9665-57133596650510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-5) 2024-09-24NoNoHistorical
71335-9665-67133596650621 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-6) 2024-01-24NoNoHistorical
71335-9665-77133596650790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-7) 2026-04-13NoNoHistorical
71335-9665-871335966508120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-8) 2026-04-13NoNoHistorical
71335-9665-9713359665097 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-9) 2026-04-13NoNoHistorical