misoprostol

Generic: misoprostol

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 200 ug/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-300
Product ID 72789-300_4bae2c7c-35bd-ec85-e063-6394a90a5412
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076095
Listing Expiration 2027-12-31
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 72789300
Hyphenated Format 72789-300

Supplemental Identifiers

RxCUI
317128
UPC
0372789300047
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
  • 4 TABLET in 1 BOTTLE, PLASTIC (72789-300-04)
  • 8 TABLET in 1 BOTTLE, PLASTIC (72789-300-08)
  • 20 TABLET in 1 BOTTLE, PLASTIC (72789-300-20)
source: ndc

Packages (3)

72789-300-04 4 TABLET in 1 BOTTLE, PLASTIC (72789-300-04) 72789-300-08 8 TABLET in 1 BOTTLE, PLASTIC (72789-300-08) 72789-300-20 20 TABLET in 1 BOTTLE, PLASTIC (72789-300-20)

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": "4bae2c7c-35bd-ec85-e063-6394a90a5412", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0372789300047"], "unii": ["0E43V0BB57"], "rxcui": ["317128"], "spl_set_id": ["51b0bac5-19e3-4547-ba1f-01494fda7687"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE, PLASTIC (72789-300-04)", "package_ndc": "72789-300-04", "marketing_start_date": "20230216"}, {"sample": false, "description": "8 TABLET in 1 BOTTLE, PLASTIC (72789-300-08)", "package_ndc": "72789-300-08", "marketing_start_date": "20230216"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (72789-300-20)", "package_ndc": "72789-300-20", "marketing_start_date": "20230308"}], "brand_name": "Misoprostol", "product_id": "72789-300_4bae2c7c-35bd-ec85-e063-6394a90a5412", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "72789-300", "generic_name": "Misoprostol", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20271231"}