FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
72162-1734
11-digit product format
721621734
Labeler code
72162
Product ID
72162-1734_daaf314b-5e73-4b47-895a-19f37bea7a0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
Substance
DICLOFENAC SODIUM
Active strength
75 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
Brand name suffix
Delayed Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855926

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
72162-1734-0Diclofenac Sodium Delayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1000103
72162-1734-1Diclofenac Sodium Delayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100103
72162-1734-3Diclofenac Sodium Delayed Release30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30103
72162-1734-4Diclofenac Sodium Delayed Release20 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE20103
72162-1734-5Diclofenac Sodium Delayed Release500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE500103
72162-1734-6Diclofenac Sodium Delayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE60103
72162-1734-7Diclofenac Sodium Delayed Release14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE14103
72162-1734-8Diclofenac Sodium Delayed Release15 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE15103
72162-1734-9Diclofenac Sodium Delayed Release90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1734-1EA - Each72162-1734746f107c-f75a-4654-bb17-1bb3d73af14a12023-12-05
72162-1734-3EA - Each72162-173446b75da2-7ea6-49ae-96a3-2771ac5261c112023-10-16
72162-1734-4EA - Each72162-17349d64d354-5822-4c53-a1cd-038373ce53f212023-10-16
72162-1734-6EA - Each72162-17344375e3db-d2d9-4e87-bbe4-fad560b57c7c12023-10-16
72162-1734-7EA - Each72162-1734b76fb1ec-63d9-4fc1-adc1-b1b5a74775bf12023-10-16
72162-1734-8EA - Each72162-17348cc6b915-6ac8-4b8a-b18e-786f564ba1d612023-10-16
72162-1734-9EA - Each72162-1734bc394c15-2ec6-4da5-889f-d126deff26b512023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1734DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]103Current NDC, 9 package rows20250215_df5bb0e7-a3a9-4650-aae7-9a11ce615d5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNdf5bb0e7-a3a9-4650-aae7-9a11ce615d5d103
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDdf5bb0e7-a3a9-4650-aae7-9a11ce615d5d103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1734-0721621734001000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-0) 2023-05-08NoNoHistorical
72162-1734-172162173401100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-1) 2023-05-08NoNoHistorical
72162-1734-37216217340330 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-3) 2023-05-08NoNoHistorical
72162-1734-47216217340420 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-4) 2023-05-08NoNoHistorical
72162-1734-572162173405500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-5) 2023-05-08NoNoHistorical
72162-1734-67216217340660 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-6) 2023-05-08NoNoHistorical
72162-1734-77216217340714 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-7) 2023-05-08NoNoHistorical
72162-1734-87216217340815 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-8) 2023-05-08NoNoHistorical
72162-1734-97216217340990 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-9) 2023-05-08NoNoHistorical