misoprostol

Generic: misoprostol

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

Drug Facts

Product Profile

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

misoprostol 200 ug/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-161
Product ID 43386-161_b702aa1b-6c21-e44f-e053-2995a90a16f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091667
Listing Expiration 2026-12-31
Marketing Start 2012-07-25

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 43386161
Hyphenated Format 43386-161

Supplemental Identifiers

RxCUI
311727 317128
UPC
0343386160068
UNII
0E43V0BB57
NUI
N0000175785 M0017811

Packaging Origin

Original Packager
true

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 ANDA091667 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43386-161-01)
  • 60 TABLET in 1 BOTTLE (43386-161-06)
source: ndc

Packages (2)

43386-161-01 100 TABLET in 1 BOTTLE (43386-161-01) 43386-161-06 60 TABLET in 1 BOTTLE (43386-161-06)

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": "b702aa1b-6c21-e44f-e053-2995a90a16f2", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0343386160068"], "unii": ["0E43V0BB57"], "rxcui": ["311727", "317128"], "spl_set_id": ["14f73ae3-7d8d-4d10-b668-8bd5adf8032c"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (43386-161-01)", "package_ndc": "43386-161-01", "marketing_start_date": "20120725"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43386-161-06)", "package_ndc": "43386-161-06", "marketing_start_date": "20120725"}], "brand_name": "Misoprostol", "product_id": "43386-161_b702aa1b-6c21-e44f-e053-2995a90a16f2", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "43386-161", "generic_name": "Misoprostol", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Misoprostol", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "200 ug/1"}], "application_number": "ANDA091667", "marketing_category": "ANDA", "marketing_start_date": "20120725", "listing_expiration_date": "20261231"}