FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
72162-1733
11-digit product format
721621733
Labeler code
72162
Product ID
72162-1733_32b578e0-6567-473c-894a-b8ba9d59b4b5
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
50 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 SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72162-1733-0Diclofenac Sodium Delayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1000104
72162-1733-1Diclofenac Sodium Delayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100104
72162-1733-2Diclofenac Sodium Delayed Release120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE120104
72162-1733-3Diclofenac Sodium Delayed Release30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30104
72162-1733-6Diclofenac Sodium Delayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE60104
72162-1733-7Diclofenac Sodium Delayed Release14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE14104
72162-1733-8Diclofenac Sodium Delayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1000104
72162-1733-9Diclofenac Sodium Delayed Release90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1733-0EA - Each72162-1733aa04f0bd-5c06-4deb-a27c-2b318f1558f912024-09-09
72162-1733-1EA - Each72162-1733f2aa2943-d588-488d-9659-86b39602e46212023-12-05
72162-1733-2EA - Each72162-1733ff0744fe-e6b3-45ab-8c87-e80318c5181012023-10-16
72162-1733-3EA - Each72162-17332f9daf7f-5df7-4d45-be8e-2174b4121fb212023-10-16
72162-1733-6EA - Each72162-17332d6c588d-9fb4-4716-84e6-9708ed71e3ef12023-10-16
72162-1733-7EA - Each72162-17336b0217fb-d65e-4410-bf23-d6ee95a5e8ac12023-10-16
72162-1733-8EA - Each72162-17336524868f-b35e-4c1a-ac9f-330496d2746612024-09-09
72162-1733-9EA - Each72162-17338a3b48b6-9810-4447-9646-8e7e0a10345e12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1733DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]104Current NDC, 8 package rows20240829_12cce748-a7de-4b1e-9603-b5c2ce12d531.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN12cce748-a7de-4b1e-9603-b5c2ce12d531104
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD12cce748-a7de-4b1e-9603-b5c2ce12d531104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1733-0721621733001000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-0) 2024-08-12NoNoHistorical
72162-1733-172162173301100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-1) 2024-08-12NoNoHistorical
72162-1733-272162173302120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-2) 2024-08-12NoNoHistorical
72162-1733-37216217330330 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-3) 2024-08-12NoNoHistorical
72162-1733-67216217330660 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-6) 2024-08-12NoNoHistorical
72162-1733-77216217330714 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-7) 2024-08-12NoNoHistorical
72162-1733-8721621733081000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-8) 2024-08-12NoNoHistorical
72162-1733-97216217330990 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-9) 2024-08-12NoNoHistorical