misoprostol

Generic: misoprostol

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

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 100 ug/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2455
Product ID 71335-2455_217bb889-8ae4-465c-9a61-1b6deec72131
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 713352455
Hyphenated Format 71335-2455

Supplemental Identifiers

RxCUI
311727
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
  • 100 ug/1
source: ndc
Packaging
  • 28 TABLET in 1 BOTTLE (71335-2455-1)
  • 90 TABLET in 1 BOTTLE (71335-2455-2)
  • 30 TABLET in 1 BOTTLE (71335-2455-3)
source: ndc

Packages (3)

71335-2455-1 28 TABLET in 1 BOTTLE (71335-2455-1) 71335-2455-2 90 TABLET in 1 BOTTLE (71335-2455-2) 71335-2455-3 30 TABLET in 1 BOTTLE (71335-2455-3)

Ingredients (1)

misoprostol (100 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": "217bb889-8ae4-465c-9a61-1b6deec72131", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["0E43V0BB57"], "rxcui": ["311727"], "spl_set_id": ["c4668066-3d67-487d-9071-f1e504f66499"], "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": "28 TABLET in 1 BOTTLE (71335-2455-1)", "package_ndc": "71335-2455-1", "marketing_start_date": "20240820"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-2455-2)", "package_ndc": "71335-2455-2", "marketing_start_date": "20240820"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-2455-3)", "package_ndc": "71335-2455-3", "marketing_start_date": "20240820"}], "brand_name": "Misoprostol", "product_id": "71335-2455_217bb889-8ae4-465c-9a61-1b6deec72131", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "71335-2455", "generic_name": "Misoprostol", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Misoprostol", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "100 ug/1"}], "application_number": "ANDA076095", "marketing_category": "ANDA", "marketing_start_date": "20220411", "listing_expiration_date": "20261231"}