FDA.reportPublic FDA data

Diclofenac Sodium Misoprostol

Product NDC
75834-264
11-digit product format
758340264
Labeler code
75834
Product ID
75834-264_542fd9dd-a6d3-4432-9e7a-2ca5bce12956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium and misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA205143
Marketing category
ANDA
Marketing start
2021-07-15
Substance
DICLOFENAC SODIUM; MISOPROSTOL
Active strength
50; 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 SODIUM50 mg/1
MISOPROSTOL200 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0E43V0BB57, QTG126297Q
Rxcui857706, 1359105

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ee46d8-7228-4160-88ad-868cc5abf72fProduct name520260223
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
75834-264-60Diclofenac Sodium Misoprostol60 in 1 BOTTLETABLET, DELAYED RELEASE605
75834-264-90Diclofenac Sodium Misoprostol90 in 1 BOTTLETABLET, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-264-60EA - Each75834-2640ef1d895-fb12-418f-a382-d58c343be50712021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-264DICLOFENAC SODIUM MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [NIVAGEN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20250507_2acf46ac-8ba8-444d-b421-19d5ad49644c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSNde4c02a5-87e8-42f5-a9ff-f409ff9e6d62101
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDde4c02a5-87e8-42f5-a9ff-f409ff9e6d62101
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYde4c02a5-87e8-42f5-a9ff-f409ff9e6d62101
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSYde4c02a5-87e8-42f5-a9ff-f409ff9e6d62101
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN2acf46ac-8ba8-444d-b421-19d5ad49644c5
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN2acf46ac-8ba8-444d-b421-19d5ad49644c5
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD2acf46ac-8ba8-444d-b421-19d5ad49644c5
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD2acf46ac-8ba8-444d-b421-19d5ad49644c5
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY2acf46ac-8ba8-444d-b421-19d5ad49644c5
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY2acf46ac-8ba8-444d-b421-19d5ad49644c5
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSY2acf46ac-8ba8-444d-b421-19d5ad49644c5
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY2acf46ac-8ba8-444d-b421-19d5ad49644c5
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN33f7db0b-f049-4d2e-abf5-4db97222e1753
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN33f7db0b-f049-4d2e-abf5-4db97222e1753
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD33f7db0b-f049-4d2e-abf5-4db97222e1753
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD33f7db0b-f049-4d2e-abf5-4db97222e1753
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY33f7db0b-f049-4d2e-abf5-4db97222e1753
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY33f7db0b-f049-4d2e-abf5-4db97222e1753
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSY33f7db0b-f049-4d2e-abf5-4db97222e1753
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY33f7db0b-f049-4d2e-abf5-4db97222e1753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
75834-264-607583402646060 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-60) 2021-07-150000-00-00NoNoCurrent
75834-264-907583402649090 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-264-90) 2021-07-150000-00-00NoNoCurrent