FDA.reportPublic FDA data

Diclofenac Sodium/Misoprostol

Product NDC
71335-2603
11-digit product format
713352603
Labeler code
71335
Product ID
71335-2603_3ee6724b-9623-434d-ac18-f5d5f55b456b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium/Misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204355
Marketing category
ANDA
Marketing start
2021-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium/Misoprostol
Brand name suffix
DICLOFENAC-SODIUM-MISOPROSTOL
Listing expiration
2026-12-31

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
71335-2603-1Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL20 in 1 BOTTLETABLET201
71335-2603-2Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL14 in 1 BOTTLETABLET141
71335-2603-3Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL60 in 1 BOTTLETABLET601
71335-2603-4Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL30 in 1 BOTTLETABLET301
71335-2603-5Diclofenac Sodium/MisoprostolDICLOFENAC-SODIUM-MISOPROSTOL10 in 1 BOTTLETABLET101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN7225385c-501c-4e90-8948-8617d583108c1
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD7225385c-501c-4e90-8948-8617d583108c1
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY7225385c-501c-4e90-8948-8617d583108c1
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY7225385c-501c-4e90-8948-8617d583108c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2603-17133526030120 TABLET in 1 BOTTLE (71335-2603-1) 20 tablet2025-06-04NoNoHistorical
71335-2603-27133526030214 TABLET in 1 BOTTLE (71335-2603-2) 14 tablet2025-06-04NoNoHistorical
71335-2603-37133526030360 TABLET in 1 BOTTLE (71335-2603-3) 60 tablet2025-06-04NoNoHistorical
71335-2603-47133526030430 TABLET in 1 BOTTLE (71335-2603-4) 30 tablet2025-06-04NoNoHistorical
71335-2603-57133526030510 TABLET in 1 BOTTLE (71335-2603-5) 10 tablet2025-06-04NoNoHistorical