diclofenac sodium misoprostol

Generic: diclofenac sodium and misoprostol

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

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

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2518
Product ID 72162-2518_377c0f85-1a9b-fd44-e063-6394a90a8e1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205143
Listing Expiration 2026-12-31
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 721622518
Hyphenated Format 72162-2518

Supplemental Identifiers

RxCUI
857706
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 misoprostol (source: ndc)
Generic Name diclofenac sodium and misoprostol (source: ndc)
Application Number ANDA205143 (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 (72162-2518-6)
source: ndc

Packages (1)

72162-2518-6 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2518-6)

Ingredients (2)

diclofenac sodium (50 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": "377c0f85-1a9b-fd44-e063-6394a90a8e1e", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706"], "spl_set_id": ["de4c02a5-87e8-42f5-a9ff-f409ff9e6d62"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2518-6)", "package_ndc": "72162-2518-6", "marketing_start_date": "20250613"}], "brand_name": "Diclofenac Sodium Misoprostol", "product_id": "72162-2518_377c0f85-1a9b-fd44-e063-6394a90a8e1e", "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": "72162-2518", "generic_name": "diclofenac sodium and misoprostol", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium Misoprostol", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA205143", "marketing_category": "ANDA", "marketing_start_date": "20210715", "listing_expiration_date": "20261231"}