misoprostol

Generic: misoprostol

Labeler: novel laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name misoprostol
Generic Name misoprostol
Labeler novel laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

misoprostol 100 ug/1

Manufacturer
Novel Laboratories, Inc.

Identifiers & Regulatory

Product NDC 40032-160
Product ID 40032-160_b702ac6b-e9de-04a9-e053-2995a90a908d
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 40032160
Hyphenated Format 40032-160

Supplemental Identifiers

RxCUI
311727 317128
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
  • 100 ug/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (40032-160-06)
  • 120 TABLET in 1 BOTTLE (40032-160-12)
source: ndc

Packages (2)

40032-160-06 60 TABLET in 1 BOTTLE (40032-160-06) 40032-160-12 120 TABLET in 1 BOTTLE (40032-160-12)

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": "b702ac6b-e9de-04a9-e053-2995a90a908d", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["0E43V0BB57"], "rxcui": ["311727", "317128"], "spl_set_id": ["a46d05a2-5014-40ff-8f1b-9eca1b0aff3a"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["Novel Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (40032-160-06)", "package_ndc": "40032-160-06", "marketing_start_date": "20120725"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE (40032-160-12)", "package_ndc": "40032-160-12", "marketing_start_date": "20120725"}], "brand_name": "Misoprostol", "product_id": "40032-160_b702ac6b-e9de-04a9-e053-2995a90a908d", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "40032-160", "generic_name": "Misoprostol", "labeler_name": "Novel Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Misoprostol", "active_ingredients": [{"name": "MISOPROSTOL", "strength": "100 ug/1"}], "application_number": "ANDA091667", "marketing_category": "ANDA", "marketing_start_date": "20120725", "listing_expiration_date": "20261231"}