FDA.reportPublic FDA data

Diclofenac sodium and Misoprostol

Product NDC
80425-0272
11-digit product format
804250272
Labeler code
80425
Product ID
80425-0272_1213898d-dffc-ce28-e063-6394a90a1a28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac sodium and Misoprostol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
NDA020607
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-02-23
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 and Misoprostol
Brand name suffix
DR
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
80425-0272-1Diclofenac sodium and MisoprostolDR60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0272-1EA - Each80425-027243394095-1b48-4f83-bce6-1e33acf2768f12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0272DICLOFENAC SODIUM AND MISOPROSTOL DR (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 1 package rows20240224_1213d3eb-9870-f144-e063-6394a90a6088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN1213d3eb-9870-f144-e063-6394a90a60881
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD1213d3eb-9870-f144-e063-6394a90a60881
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY1213d3eb-9870-f144-e063-6394a90a60881
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY1213d3eb-9870-f144-e063-6394a90a60881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0272-18042502720160 TABLET, FILM COATED in 1 BOTTLE (80425-0272-1) 2024-02-23NoNoHistorical