FDA.reportPublic FDA data

Diclofenac Sodium and Misoprostol

Product NDC
50090-4618
11-digit product format
500904618
Labeler code
50090
Product ID
50090-4618_f03b3383-19af-4b8f-a544-d476186549c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium and Misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203995
Marketing category
ANDA
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM; MISOPROSTOL
Active strength
75 mg/1; ug/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9Product name320231221
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4618-02023-01-30C16284748780-1f386c649-f3c4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS. DICLOFENAC SODIUM and MISOPROSTOL delayed-release tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4618-0Diclofenac Sodium and Misoprostol60 in 1 BOTTLETABLET, DELAYED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4618DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]4Legacy NDC, 1 package rows20210615_90d48047-37d0-4418-86b9-b7283cf46d72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN90d48047-37d0-4418-86b9-b7283cf46d724
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD90d48047-37d0-4418-86b9-b7283cf46d724
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY90d48047-37d0-4418-86b9-b7283cf46d724
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY90d48047-37d0-4418-86b9-b7283cf46d724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4618-05009046180060 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4618-0) 2019-10-170000-00-00NoNoCurrent