FDA.reportPublic FDA data

Diclofenac Sodium and Misoprostol

Product NDC
0591-0398
11-digit product format
005910398
Labeler code
0591
Product ID
0591-0398_9d8d5f09-7764-4e55-87c6-d2fead0e6e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium and Misoprostol
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA201089
Marketing category
ANDA
Marketing start
2012-11-01
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
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
0591-0398-60Diclofenac Sodium and Misoprostol60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0398-19EA - Each0591-03980eaeac17-2a32-4a6a-8b03-6ff081f39ba712015-11-12
0591-0398-60EA - Each0591-03987042a39c-38de-4b68-8def-bbf56e2db47a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
MISOPROSTOLACTIVE MOIETY0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
MISOPROSTOLACTIVE MOIETY0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0398DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]35Current NDC, Legacy NDC, 1 package rows20250110_df8b8660-0c24-4848-8bea-c1b935090c66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSNdf8b8660-0c24-4848-8bea-c1b935090c6637
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSNdf8b8660-0c24-4848-8bea-c1b935090c6637
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDdf8b8660-0c24-4848-8bea-c1b935090c6637
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDdf8b8660-0c24-4848-8bea-c1b935090c6637
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYdf8b8660-0c24-4848-8bea-c1b935090c6637
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYdf8b8660-0c24-4848-8bea-c1b935090c6637
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSYdf8b8660-0c24-4848-8bea-c1b935090c6637
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSYdf8b8660-0c24-4848-8bea-c1b935090c6637
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSY3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY3643ab1b-9f8f-b2f4-e02d-950d0a02e5879
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN219caa9b-96f2-643e-e054-00144ff88e881
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD219caa9b-96f2-643e-e054-00144ff88e881
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY219caa9b-96f2-643e-e054-00144ff88e881
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY219caa9b-96f2-643e-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-0398-600059103986060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0398-60) 2012-11-010000-00-00NoNoCurrent