diclofenac sodium and misoprostol

Generic: diclofenac sodium and misoprostol

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium and misoprostol
Generic Name diclofenac sodium and misoprostol
Labeler avkare
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 50 mg/1, misoprostol 200 ug/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-232
Product ID 42291-232_4458d931-cb59-7a13-e063-6294a90ad97e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201089
Listing Expiration 2026-12-31
Marketing Start 2012-12-14

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 42291232
Hyphenated Format 42291-232

Supplemental Identifiers

RxCUI
857706 1359105
UNII
QTG126297Q 0E43V0BB57
NUI
N0000175785 M0017811

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 ANDA201089 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 200 ug/1
source: ndc
Packaging
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-232-60)
source: ndc

Packages (1)

42291-232-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-232-60)

Ingredients (2)

diclofenac sodium (50 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": "4458d931-cb59-7a13-e063-6294a90ad97e", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105"], "spl_set_id": ["3643ab1b-9f8f-b2f4-e02d-950d0a02e587"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-232-60)", "package_ndc": "42291-232-60", "marketing_start_date": "20160926"}], "brand_name": "Diclofenac Sodium and Misoprostol", "product_id": "42291-232_4458d931-cb59-7a13-e063-6294a90ad97e", "dosage_form": "TABLET, DELAYED RELEASE", "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": "42291-232", "generic_name": "Diclofenac Sodium and Misoprostol", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium and Misoprostol", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA201089", "marketing_category": "ANDA", "marketing_start_date": "20121214", "listing_expiration_date": "20261231"}