diclofenac sodium and misoprostol (0591-0397)

Drug Facts

Product Profile

Brand Name diclofenac sodium and misoprostol

Generic Name diclofenac sodium and misoprostol

Labeler actavis pharma, inc.

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-0397

Product ID 0591-0397_03f24a4c-0fe7-446a-b64d-a7c6b12cae0f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA201089

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 05910397

Hyphenated Format 0591-0397

Supplemental Identifiers

RxCUI

857706 1359105

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 ANDA201089 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

50 mg/1
200 ug/1

source: ndc

Packaging

90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19)
60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)

source: ndc

Packages (2)

0591-0397-19 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19) 0591-0397-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)

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": "03f24a4c-0fe7-446a-b64d-a7c6b12cae0f", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105"], "spl_set_id": ["df8b8660-0c24-4848-8bea-c1b935090c66"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-19)", "package_ndc": "0591-0397-19", "marketing_start_date": "20121101"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60)", "package_ndc": "0591-0397-60", "marketing_start_date": "20121101"}], "brand_name": "Diclofenac Sodium and Misoprostol", "product_id": "0591-0397_03f24a4c-0fe7-446a-b64d-a7c6b12cae0f", "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": "0591-0397", "generic_name": "Diclofenac Sodium and Misoprostol", "labeler_name": "Actavis Pharma, Inc.", "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": "20121101", "listing_expiration_date": "20261231"}