diclofenac sodium/misoprostol diclofenac-sodium-misoprostol

Generic: diclofenac sodium/misoprostol

Labeler: micro labs limited
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 micro labs limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-133
Product ID 42571-133_3afc5367-562f-b4a0-e063-6294a90a2560
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 42571133
Hyphenated Format 42571-133

Supplemental Identifiers

RxCUI
857706 1359105
UPC
0342571133603 0342571134600
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 diclofenac-sodium-misoprostol (source: ndc)
Generic Name diclofenac sodium/misoprostol (source: ndc)
Application Number ANDA204355 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 200 ug/1
source: ndc
Packaging
  • 60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (42571-133-30)
  • 60 TABLET in 1 BOTTLE (42571-133-60)
  • 90 TABLET in 1 BOTTLE (42571-133-90)
source: ndc

Packages (4)

42571-133-29 60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK 42571-133-30 30 TABLET in 1 BOTTLE (42571-133-30) 42571-133-60 60 TABLET in 1 BOTTLE (42571-133-60) 42571-133-90 90 TABLET in 1 BOTTLE (42571-133-90)

Ingredients (2)

diclofenac sodium (50 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": "3afc5367-562f-b4a0-e063-6294a90a2560", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0342571133603", "0342571134600"], "unii": ["QTG126297Q", "0E43V0BB57"], "rxcui": ["857706", "1359105"], "spl_set_id": ["c61df58d-d6bb-4d3e-9ef8-60caa7d4e762"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 BLISTER PACK in 1 CARTON (42571-133-29)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "42571-133-29", "marketing_start_date": "20210901"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (42571-133-30)", "package_ndc": "42571-133-30", "marketing_start_date": "20210901"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (42571-133-60)", "package_ndc": "42571-133-60", "marketing_start_date": "20210901"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (42571-133-90)", "package_ndc": "42571-133-90", "marketing_start_date": "20210901"}], "brand_name": "Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL", "product_id": "42571-133_3afc5367-562f-b4a0-e063-6294a90a2560", "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": "42571-133", "generic_name": "Diclofenac Sodium/Misoprostol", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium/Misoprostol", "brand_name_suffix": "DICLOFENAC-SODIUM-MISOPROSTOL", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}, {"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA204355", "marketing_category": "ANDA", "marketing_start_date": "20210901", "listing_expiration_date": "20261231"}