FDA.reportPublic FDA data

Diclofenac sodium and Misoprostol

Product NDC
59762-0029
11-digit product format
597620029
Labeler code
59762
Product ID
59762-0029_540456cf-d8d4-4c2f-883d-933c5d0b862b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac sodium and Misoprostol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020607
Marketing category
NDA AUTHORIZED GENERIC
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
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
59762-0029-1Diclofenac sodium and Misoprostol60 in 1 BOTTLETABLET, FILM COATED6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0029-1EA - Each59762-0029e27d956d-74fa-4915-b86b-a8c15258594012013-02-13
59762-0029-3EA - Each59762-002986229ea9-6038-40eb-a93c-02c79e8fcc0412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
MISOPROSTOLACTIVE MOIETY0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0029DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]22Current NDC, Legacy NDC, 1 package rows20250524_a7701e8c-4e16-4165-8b83-de2c08d5ded3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857706diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSNa7701e8c-4e16-4165-8b83-de2c08d5ded323
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSNa7701e8c-4e16-4165-8b83-de2c08d5ded323
857706diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDa7701e8c-4e16-4165-8b83-de2c08d5ded323
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCDa7701e8c-4e16-4165-8b83-de2c08d5ded323
857706diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYa7701e8c-4e16-4165-8b83-de2c08d5ded323
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSYa7701e8c-4e16-4165-8b83-de2c08d5ded323
857706diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral TabletSYa7701e8c-4e16-4165-8b83-de2c08d5ded323
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSYa7701e8c-4e16-4165-8b83-de2c08d5ded323
1359105diclofenac sodium 75 MG / miSOPROStol 0.2 MG Delayed Release Oral TabletPSN253ee985-e0a0-4674-a114-cfea96304c795
1359105diclofenac sodium 75 MG / misoprostol 0.2 MG Delayed Release Oral TabletSCD253ee985-e0a0-4674-a114-cfea96304c795
1359105diclofenac sodium (enteric coated core) 75 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral TabletSY253ee985-e0a0-4674-a114-cfea96304c795
1359105diclofenac sodium 75 MG / misoprostol 200 MCG Delayed Release Oral TabletSY253ee985-e0a0-4674-a114-cfea96304c795
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 startMarketing endSampleExclude flagStatus
59762-0029-15976200290160 TABLET, FILM COATED in 1 BOTTLE (59762-0029-1) 2012-11-010000-00-00NoNoCurrent