FDA.reportPublic FDA data

Diclofenac Sodium and Misoprostol

Product NDC
65162-438
11-digit product format
651620438
Labeler code
65162
Product ID
65162-438_0426969f-80c3-4157-b42a-ad57d204d011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium and Misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA203995
Marketing category
ANDA
Marketing start
2016-12-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium and 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
Rxcui857706, 1359105

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
65162-438-03Diclofenac Sodium and Misoprostol30 in 1 BOTTLETABLET, DELAYED RELEASE3027
65162-438-06Diclofenac Sodium and Misoprostol60 in 1 BOTTLETABLET, DELAYED RELEASE6027
65162-438-10Diclofenac Sodium and Misoprostol100 in 1 BOTTLETABLET, DELAYED RELEASE10027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-438-06EA - Each65162-4389ad12ca3-dc25-49f7-8a02-a5306a9a8ad812017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-438DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC]26Current NDC, Legacy NDC, 3 package rows20241215_afd30051-8f59-474b-9972-962a5a871dfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSNafd30051-8f59-474b-9972-962a5a871dfb27
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSNafd30051-8f59-474b-9972-962a5a871dfb27
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDafd30051-8f59-474b-9972-962a5a871dfb27
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDafd30051-8f59-474b-9972-962a5a871dfb27
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYafd30051-8f59-474b-9972-962a5a871dfb27
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYafd30051-8f59-474b-9972-962a5a871dfb27
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSYafd30051-8f59-474b-9972-962a5a871dfb27
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSYafd30051-8f59-474b-9972-962a5a871dfb27
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 TabletPSNd6671b66-00ad-4949-b51a-36e1130b1cb54
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD90d48047-37d0-4418-86b9-b7283cf46d724
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDd6671b66-00ad-4949-b51a-36e1130b1cb54
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY90d48047-37d0-4418-86b9-b7283cf46d724
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYd6671b66-00ad-4949-b51a-36e1130b1cb54
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY90d48047-37d0-4418-86b9-b7283cf46d724
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSYd6671b66-00ad-4949-b51a-36e1130b1cb54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-438-036516204380330 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-03) 2016-12-010000-00-00NoNoCurrent
65162-438-066516204380660 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-06) 2016-12-010000-00-00NoNoCurrent
65162-438-1065162043810100 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-10) 2016-12-010000-00-00NoNoCurrent