diclofenac sodium/misoprostol diclofenac-sodium-misoprostol

Generic: diclofenac sodium/misoprostol

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

Drug Facts

Product Profile

Brand Name diclofenac sodium/misoprostol diclofenac-sodium-misoprostol
Generic Name diclofenac sodium/misoprostol
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2603
Product ID 71335-2603_3ee6724b-9623-434d-ac18-f5d5f55b456b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204355
Listing Expiration 2026-12-31
Marketing Start 2021-09-01

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 713352603
Hyphenated Format 71335-2603

Supplemental Identifiers

RxCUI
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/misoprostol diclofenac-sodium-misoprostol (source: ndc)
Generic Name diclofenac sodium/misoprostol (source: ndc)
Application Number ANDA204355 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
  • 200 ug/1
source: ndc
Packaging
  • 20 TABLET in 1 BOTTLE (71335-2603-1)
  • 14 TABLET in 1 BOTTLE (71335-2603-2)
  • 60 TABLET in 1 BOTTLE (71335-2603-3)
  • 30 TABLET in 1 BOTTLE (71335-2603-4)
  • 10 TABLET in 1 BOTTLE (71335-2603-5)
source: ndc

Packages (5)

71335-2603-1 20 TABLET in 1 BOTTLE (71335-2603-1) 71335-2603-2 14 TABLET in 1 BOTTLE (71335-2603-2) 71335-2603-3 60 TABLET in 1 BOTTLE (71335-2603-3) 71335-2603-4 30 TABLET in 1 BOTTLE (71335-2603-4) 71335-2603-5 10 TABLET in 1 BOTTLE (71335-2603-5)

Ingredients (2)

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

Linked Drug Pages (1)

Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ee6724b-9623-434d-ac18-f5d5f55b456b", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["1359105"], "spl_set_id": ["7225385c-501c-4e90-8948-8617d583108c"], "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": "20 TABLET in 1 BOTTLE (71335-2603-1)", "package_ndc": "71335-2603-1", "marketing_start_date": "20250604"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (71335-2603-2)", "package_ndc": "71335-2603-2", "marketing_start_date": "20250604"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-2603-3)", "package_ndc": "71335-2603-3", "marketing_start_date": "20250604"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-2603-4)", "package_ndc": "71335-2603-4", "marketing_start_date": "20250604"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE (71335-2603-5)", "package_ndc": "71335-2603-5", "marketing_start_date": "20250604"}], "brand_name": "Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL", "product_id": "71335-2603_3ee6724b-9623-434d-ac18-f5d5f55b456b", "dosage_form": "TABLET", "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": "71335-2603", "generic_name": "Diclofenac Sodium/Misoprostol", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium/Misoprostol", "brand_name_suffix": "DICLOFENAC-SODIUM-MISOPROSTOL", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA204355", "marketing_category": "ANDA", "marketing_start_date": "20210901", "listing_expiration_date": "20261231"}