misoprostol

Generic: misoprostol

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

misoprostol 100 ug/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3762
Product ID 68071-3762_2bae87bf-4da1-e8b7-e063-6394a90a2f90
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 680713762
Hyphenated Format 68071-3762

Supplemental Identifiers

RxCUI
311727
UPC
0368071376234
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
  • 30 TABLET in 1 BOTTLE (68071-3762-3)
  • 90 TABLET in 1 BOTTLE (68071-3762-9)
source: ndc

Packages (2)

68071-3762-3 30 TABLET in 1 BOTTLE (68071-3762-3) 68071-3762-9 90 TABLET in 1 BOTTLE (68071-3762-9)

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": "2bae87bf-4da1-e8b7-e063-6394a90a2f90", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0368071376234"], "unii": ["0E43V0BB57"], "rxcui": ["311727"], "spl_set_id": ["2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c8"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-3762-3)", "package_ndc": "68071-3762-3", "marketing_start_date": "20250110"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3762-9)", "package_ndc": "68071-3762-9", "marketing_start_date": "20250114"}], "brand_name": "Misoprostol", "product_id": "68071-3762_2bae87bf-4da1-e8b7-e063-6394a90a2f90", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "68071-3762", "generic_name": "Misoprostol", "labeler_name": "NuCare Pharmaceuticals, Inc.", "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"}