misoprostol

Generic: misoprostol

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 200 ug/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-037
Product ID 82804-037_85410e16-d164-4666-9539-778e2b4dd138
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076095
Listing Expiration 2026-12-31
Marketing Start 2022-04-11

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 82804037
Hyphenated Format 82804-037

Supplemental Identifiers

RxCUI
317128
UPC
0382804037100
UNII
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 misoprostol (source: ndc)
Generic Name misoprostol (source: ndc)
Application Number ANDA076095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (82804-037-10)
  • 20 TABLET in 1 BOTTLE (82804-037-20)
  • 30 TABLET in 1 BOTTLE (82804-037-30)
  • 60 TABLET in 1 BOTTLE (82804-037-60)
  • 90 TABLET in 1 BOTTLE (82804-037-90)
source: ndc

Packages (5)

82804-037-10 10 TABLET in 1 BOTTLE (82804-037-10) 82804-037-20 20 TABLET in 1 BOTTLE (82804-037-20) 82804-037-30 30 TABLET in 1 BOTTLE (82804-037-30) 82804-037-60 60 TABLET in 1 BOTTLE (82804-037-60) 82804-037-90 90 TABLET in 1 BOTTLE (82804-037-90)

Ingredients (1)

misoprostol (200 ug/1)

Linked Drug Pages (1)

Misoprostol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "85410e16-d164-4666-9539-778e2b4dd138", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0382804037100"], "unii": ["0E43V0BB57"], "rxcui": ["317128"], "spl_set_id": ["85410e16-d164-4666-9539-778e2b4dd138"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (82804-037-10)", "package_ndc": "82804-037-10", "marketing_start_date": "20231107"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (82804-037-20)", "package_ndc": "82804-037-20", "marketing_start_date": "20231107"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-037-30)", "package_ndc": "82804-037-30", "marketing_start_date": "20231107"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (82804-037-60)", "package_ndc": "82804-037-60", "marketing_start_date": "20231107"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (82804-037-90)", "package_ndc": "82804-037-90", "marketing_start_date": "20231107"}], "brand_name": "Misoprostol", "product_id": "82804-037_85410e16-d164-4666-9539-778e2b4dd138", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "82804-037", "generic_name": "Misoprostol", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Misoprostol", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA076095", "marketing_category": "ANDA", "marketing_start_date": "20220411", "listing_expiration_date": "20261231"}