misoprostol

Generic: misoprostol

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

Drug Facts

Product Profile

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

misoprostol 200 ug/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-444
Product ID 70954-444_f271c446-37dd-4a1f-8664-c8ccea4ab1ce
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 70954444
Hyphenated Format 70954-444

Supplemental Identifiers

RxCUI
311727 317128
UPC
0370954444107 0370954444206 0370954443100 0370954443209
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 ANDA076095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (70954-444-10)
  • 100 TABLET in 1 BOTTLE (70954-444-20)
source: ndc

Packages (2)

70954-444-10 60 TABLET in 1 BOTTLE (70954-444-10) 70954-444-20 100 TABLET in 1 BOTTLE (70954-444-20)

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": "f271c446-37dd-4a1f-8664-c8ccea4ab1ce", "openfda": {"nui": ["N0000175785", "M0017811"], "upc": ["0370954444107", "0370954444206", "0370954443100", "0370954443209"], "unii": ["0E43V0BB57"], "rxcui": ["311727", "317128"], "spl_set_id": ["21386aa1-dc51-41c9-8872-dec4c71ebb46"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (70954-444-10)", "package_ndc": "70954-444-10", "marketing_start_date": "20220411"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-444-20)", "package_ndc": "70954-444-20", "marketing_start_date": "20220411"}], "brand_name": "Misoprostol", "product_id": "70954-444_f271c446-37dd-4a1f-8664-c8ccea4ab1ce", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "70954-444", "generic_name": "Misoprostol", "labeler_name": "ANI Pharmaceuticals, Inc.", "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": "20220411", "listing_expiration_date": "20261231"}