FDA.reportPublic FDA data

Diclofenac Sodium and Misoprostol

Product NDC
68001-232
11-digit product format
680010232
Labeler code
68001
Product ID
68001-232_3e847cfc-d342-3a15-e063-6394a90aeb46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium and Misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA201089
Marketing category
ANDA
Marketing start
2014-02-26
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 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
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
68001-232-06Diclofenac Sodium and Misoprostol60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-232-06EA - Each68001-232fe27c429-a1e9-400e-9971-7424da92147e12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
MISOPROSTOLACTIVE MOIETY0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-232DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]11Current NDC, Legacy NDC, 1 package rows20250315_9a22cb4b-e49a-4bd7-b235-47405c302658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN9a22cb4b-e49a-4bd7-b235-47405c30265812
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN9a22cb4b-e49a-4bd7-b235-47405c30265812
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD9a22cb4b-e49a-4bd7-b235-47405c30265812
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD9a22cb4b-e49a-4bd7-b235-47405c30265812
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY9a22cb4b-e49a-4bd7-b235-47405c30265812
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY9a22cb4b-e49a-4bd7-b235-47405c30265812
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSY9a22cb4b-e49a-4bd7-b235-47405c30265812
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY9a22cb4b-e49a-4bd7-b235-47405c30265812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-232-066800102320660 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-232-06) 2014-02-260000-00-00NoNoCurrent