misoprostol

Generic: misoprostol

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 200 ug/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-2145
Product ID 55154-2145_d2ee7acd-0b65-4391-b2d1-397afc4da168
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076095
Listing Expiration 2026-12-31
Marketing Start 2024-12-10

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 551542145
Hyphenated Format 55154-2145

Supplemental Identifiers

RxCUI
317128
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 BLISTER PACK in 1 BAG (55154-2145-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-2145-0 10 BLISTER PACK in 1 BAG (55154-2145-0) / 1 TABLET in 1 BLISTER PACK

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": "d2ee7acd-0b65-4391-b2d1-397afc4da168", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["0E43V0BB57"], "rxcui": ["317128"], "spl_set_id": ["52a82e45-afc5-47d0-a77f-a225609e2f6b"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-2145-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-2145-0", "marketing_start_date": "20241210"}], "brand_name": "Misoprostol", "product_id": "55154-2145_d2ee7acd-0b65-4391-b2d1-397afc4da168", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "55154-2145", "generic_name": "Misoprostol", "labeler_name": "Cardinal Health 107, LLC", "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": "20241210", "listing_expiration_date": "20261231"}