diclofenac sodium/misoprostol diclofenac-sodium-misoprostol

Generic: diclofenac sodium/misoprostol

Labeler: preferred pharmaceuticals inc.
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 preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8214
Product ID 68788-8214_04d373d5-4825-49dc-89a4-65dc2dd6e498
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204355
Listing Expiration 2026-12-31
Marketing Start 2022-09-08

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 687888214
Hyphenated Format 68788-8214

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
  • 30 TABLET in 1 BOTTLE (68788-8214-3)
  • 60 TABLET in 1 BOTTLE (68788-8214-6)
source: ndc

Packages (2)

68788-8214-3 30 TABLET in 1 BOTTLE (68788-8214-3) 68788-8214-6 60 TABLET in 1 BOTTLE (68788-8214-6)

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": "04d373d5-4825-49dc-89a4-65dc2dd6e498", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["1359105"], "spl_set_id": ["869878e8-7391-4206-8b83-3e06fc5a4d2a"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8214-3)", "package_ndc": "68788-8214-3", "marketing_start_date": "20220908"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8214-6)", "package_ndc": "68788-8214-6", "marketing_start_date": "20220908"}], "brand_name": "Diclofenac Sodium/Misoprostol diclofenac-sodium-misoprostol", "product_id": "68788-8214_04d373d5-4825-49dc-89a4-65dc2dd6e498", "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": "68788-8214", "generic_name": "Diclofenac Sodium/Misoprostol", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20220908", "listing_expiration_date": "20261231"}