diclofenac sodium misoprostol (75834-265)

Drug Facts

Product Profile

Brand Name diclofenac sodium misoprostol

Generic Name diclofenac sodium and misoprostol

Labeler nivagen pharmaceuticals, inc.

Dosage Form TABLET, DELAYED RELEASE

Routes

ORAL

Active Ingredients

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

Manufacturer

Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-265

Product ID 75834-265_542fd9dd-a6d3-4432-9e7a-2ca5bce12956

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205143

Listing Expiration 2027-12-31

Marketing Start 2021-07-15

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 75834265

Hyphenated Format 75834-265

Supplemental Identifiers

RxCUI

857706 1359105

UPC

0375834264608 0375834265605

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 misoprostol (source: ndc)

Generic Name diclofenac sodium and misoprostol (source: ndc)

Application Number ANDA205143 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

75 mg/1
200 ug/1

source: ndc

Packaging

60 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-265-60)

source: ndc

Packages (1)

75834-265-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-265-60)

Ingredients (2)

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

Linked Drug Pages (1)

Diclofenac Sodium Misoprostol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "542fd9dd-a6d3-4432-9e7a-2ca5bce12956", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0375834264608", "0375834265605"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105"], "spl_set_id": ["2acf46ac-8ba8-444d-b421-19d5ad49644c"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (75834-265-60)", "package_ndc": "75834-265-60", "marketing_start_date": "20210715"}], "brand_name": "Diclofenac Sodium Misoprostol", "product_id": "75834-265_542fd9dd-a6d3-4432-9e7a-2ca5bce12956", "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": "75834-265", "generic_name": "diclofenac sodium and misoprostol", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium Misoprostol", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA205143", "marketing_category": "ANDA", "marketing_start_date": "20210715", "listing_expiration_date": "20271231"}