diclofenac sodium and misoprostol

Generic: diclofenac sodium and misoprostol

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium and misoprostol
Generic Name diclofenac sodium and misoprostol
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1, misoprostol 200 ug/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-0029
Product ID 59762-0029_85899b95-661f-4027-9760-31a6fd175ff0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020607
Listing Expiration 2026-12-31
Marketing Start 2012-11-01

Pharmacologic Class

Established (EPC)
prostaglandin e1 analog [epc]
Chemical Structure
prostaglandins e, synthetic [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 597620029
Hyphenated Format 59762-0029

Supplemental Identifiers

RxCUI
857706 1359105
UPC
0359762002914 0359762002815
UNII
QTG126297Q 0E43V0BB57
NUI
N0000175785 M0017811

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diclofenac sodium and misoprostol (source: ndc)
Generic Name diclofenac sodium and misoprostol (source: ndc)
Application Number NDA020607 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
  • 200 ug/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (59762-0029-1)
source: ndc

Packages (1)

59762-0029-1 60 TABLET, FILM COATED in 1 BOTTLE (59762-0029-1)

Ingredients (2)

diclofenac sodium (75 mg/1) misoprostol (200 ug/1)

Linked Drug Pages (1)

Diclofenac sodium and Misoprostol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "85899b95-661f-4027-9760-31a6fd175ff0", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0359762002914", "0359762002815"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105"], "spl_set_id": ["a7701e8c-4e16-4165-8b83-de2c08d5ded3"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (59762-0029-1)", "package_ndc": "59762-0029-1", "marketing_start_date": "20121101"}], "brand_name": "Diclofenac sodium and Misoprostol", "product_id": "59762-0029_85899b95-661f-4027-9760-31a6fd175ff0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "59762-0029", "generic_name": "Diclofenac sodium and Misoprostol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac sodium and Misoprostol", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "NDA020607", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20121101", "listing_expiration_date": "20261231"}