misoprostol

Generic: misoprostol

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

Drug Facts

Product Profile

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

misoprostol 200 ug/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-148
Product ID 54348-148_ea92d79f-b58c-2ad8-e053-2a95a90acafb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091667
Listing Expiration 2026-12-31
Marketing Start 2019-07-10

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 54348148
Hyphenated Format 54348-148

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 ANDA091667 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-148-00) / 1 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-148-01) / 1 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-148-02) / 2 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-148-03) / 3 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-148-04) / 4 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-148-06) / 6 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-148-08) / 8 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-148-09) / 9 TABLET in 1 BOTTLE
source: ndc

Packages (8)

54348-148-00 1 BOTTLE in 1 BOX (54348-148-00) / 1 TABLET in 1 BOTTLE 54348-148-01 1 BOTTLE in 1 BOX (54348-148-01) / 1 TABLET in 1 BOTTLE 54348-148-02 1 BOTTLE in 1 BOX (54348-148-02) / 2 TABLET in 1 BOTTLE 54348-148-03 1 BOTTLE in 1 BOX (54348-148-03) / 3 TABLET in 1 BOTTLE 54348-148-04 1 BOTTLE in 1 BOX (54348-148-04) / 4 TABLET in 1 BOTTLE 54348-148-06 1 BOTTLE in 1 BOX (54348-148-06) / 6 TABLET in 1 BOTTLE 54348-148-08 1 BOTTLE in 1 BOX (54348-148-08) / 8 TABLET in 1 BOTTLE 54348-148-09 1 BOTTLE in 1 BOX (54348-148-09) / 9 TABLET in 1 BOTTLE

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": "ea92d79f-b58c-2ad8-e053-2a95a90acafb", "openfda": {"nui": ["N0000175785", "M0017811"], "unii": ["0E43V0BB57"], "rxcui": ["317128"], "spl_set_id": ["b07b3dfc-1cb5-484c-be11-8d14c89c794f"], "pharm_class_cs": ["Prostaglandins E, Synthetic [CS]"], "pharm_class_epc": ["Prostaglandin E1 Analog [EPC]"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-148-00)  / 1 TABLET in 1 BOTTLE", "package_ndc": "54348-148-00", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-148-01)  / 1 TABLET in 1 BOTTLE", "package_ndc": "54348-148-01", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-148-02)  / 2 TABLET in 1 BOTTLE", "package_ndc": "54348-148-02", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-148-03)  / 3 TABLET in 1 BOTTLE", "package_ndc": "54348-148-03", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-148-04)  / 4 TABLET in 1 BOTTLE", "package_ndc": "54348-148-04", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-148-06)  / 6 TABLET in 1 BOTTLE", "package_ndc": "54348-148-06", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-148-08)  / 8 TABLET in 1 BOTTLE", "package_ndc": "54348-148-08", "marketing_start_date": "20190710"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-148-09)  / 9 TABLET in 1 BOTTLE", "package_ndc": "54348-148-09", "marketing_start_date": "20190710"}], "brand_name": "Misoprostol", "product_id": "54348-148_ea92d79f-b58c-2ad8-e053-2a95a90acafb", "dosage_form": "TABLET", "pharm_class": ["Prostaglandin E1 Analog [EPC]", "Prostaglandins E", "Synthetic [CS]"], "product_ndc": "54348-148", "generic_name": "MISOPROSTOL", "labeler_name": "PharmPak, 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": "20190710", "listing_expiration_date": "20261231"}