FDA.reportPublic FDA data

Diclofenac Sodium Misoprostol

Product NDC
71335-2441
11-digit product format
713352441
Labeler code
71335
Product ID
71335-2441_09aef351-9355-4eee-afc9-4c80b5ebf39f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium and misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205143
Marketing category
ANDA
Marketing start
2021-07-15
Substance
DICLOFENAC SODIUM; MISOPROSTOL
Active strength
75; 200 mg/1; ug/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium Misoprostol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1
MISOPROSTOL200 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q, 0E43V0BB57
Rxcui1359105

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2441-1Diclofenac Sodium Misoprostol20 in 1 BOTTLETABLET, DELAYED RELEASE202
71335-2441-2Diclofenac Sodium Misoprostol14 in 1 BOTTLETABLET, DELAYED RELEASE142
71335-2441-3Diclofenac Sodium Misoprostol60 in 1 BOTTLETABLET, DELAYED RELEASE602
71335-2441-4Diclofenac Sodium Misoprostol30 in 1 BOTTLETABLET, DELAYED RELEASE302
71335-2441-5Diclofenac Sodium Misoprostol10 in 1 BOTTLETABLET, DELAYED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2441DICLOFENAC SODIUM MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20240921_6865a5cf-3263-44b5-96d9-7a7a4c6e1c05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN6865a5cf-3263-44b5-96d9-7a7a4c6e1c052
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD6865a5cf-3263-44b5-96d9-7a7a4c6e1c052
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY6865a5cf-3263-44b5-96d9-7a7a4c6e1c052
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY6865a5cf-3263-44b5-96d9-7a7a4c6e1c052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2441-17133524410120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-1) 2024-09-18NoNoHistorical
71335-2441-27133524410214 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-2) 2024-09-18NoNoHistorical
71335-2441-37133524410360 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-3) 2024-09-18NoNoHistorical
71335-2441-47133524410430 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-4) 2024-09-18NoNoHistorical
71335-2441-57133524410510 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2441-5) 2024-09-18NoNoHistorical