FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
60760-090
11-digit product format
607600090
Labeler code
60760
Product ID
60760-090_45af5a0c-6bfa-3960-e063-6294a90ab922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA077863
Marketing category
ANDA
Marketing start
2017-11-21
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
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
60760-090-15Diclofenac Sodium15 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE158
60760-090-20Diclofenac Sodium20 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE208
60760-090-30Diclofenac Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE308
60760-090-60Diclofenac Sodium60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE608
60760-090-90Diclofenac Sodium90 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-090DICLOFENAC SODIUM TABLET, DELAYED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]6Current NDC, Legacy NDC, 5 package rows20250523_5f4b69de-8ddd-26c5-e053-2a91aa0ab326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN5f4b69de-8ddd-26c5-e053-2a91aa0ab3268
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD5f4b69de-8ddd-26c5-e053-2a91aa0ab3268

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-090-156076000901515 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-15) 2022-07-050000-00-00NoNoCurrent
60760-090-206076000902020 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-20) 2022-06-030000-00-00NoNoCurrent
60760-090-306076000903030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-30) 2025-05-13NoNoCurrent
60760-090-606076000906060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-60) 2022-07-070000-00-00NoNoCurrent
60760-090-906076000909090 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-90) 2025-06-25NoNoCurrent