FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
35356-714
11-digit product format
353560714
Labeler code
35356
Product ID
35356-714_7c056476-691c-45b0-91dd-3086105c1122
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA077863
Marketing category
ANDA
Marketing start
2008-08-19
Marketing end
2026-07-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906, 855926

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
35356-714-14Diclofenac Sodium14 in 1 BOTTLETABLET, DELAYED RELEASE143981
35356-714-15Diclofenac Sodium15 in 1 BOTTLETABLET, DELAYED RELEASE153981
35356-714-20Diclofenac Sodium20 in 1 BOTTLETABLET, DELAYED RELEASE203981
35356-714-28Diclofenac Sodium28 in 1 BOTTLETABLET, DELAYED RELEASE283981
35356-714-30Diclofenac Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE303981
35356-714-60Diclofenac Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE603981
35356-714-90Diclofenac Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE903981

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35356-714DICLOFENAC SODIUM TABLET, DELAYED RELEASE [QUALITY CARE PRODUCTS LLC]3981Current NDC, Legacy NDC, 7 package rows20241213_bfa8cb40-3528-4d41-ae77-444e521e30c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNbfa8cb40-3528-4d41-ae77-444e521e30c03981
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNbfa8cb40-3528-4d41-ae77-444e521e30c03981
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDbfa8cb40-3528-4d41-ae77-444e521e30c03981
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDbfa8cb40-3528-4d41-ae77-444e521e30c03981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
35356-714-143535607141414 in 1 BOTTLEHistorical
35356-714-153535607141515 in 1 BOTTLEHistorical
35356-714-203535607142020 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-714-20) 2013-02-070000-00-00NoNoCurrent
35356-714-283535607142828 in 1 BOTTLEHistorical
35356-714-303535607143030 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-714-30) 2013-02-070000-00-00NoNoCurrent
35356-714-603535607146060 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-714-60) 2013-02-072026-07-31NoNoCurrent
35356-714-903535607149090 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-714-90) 2013-02-070000-00-00NoNoCurrent