alvimopan

Generic: alvimopan

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alvimopan
Generic Name alvimopan
Labeler hikma pharmaceuticals usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

alvimopan 12 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0668
Product ID 0054-0668_89b02f3c-d8da-4b1f-9847-859c4efffabb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217753
Listing Expiration 2026-12-31
Marketing Start 2024-02-06

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540668
Hyphenated Format 0054-0668

Supplemental Identifiers

RxCUI
799835
UNII
677C126AET

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 alvimopan (source: ndc)
Generic Name alvimopan (source: ndc)
Application Number ANDA217753 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0054-0668-82 6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACK

Ingredients (1)

alvimopan (12 mg/1)

Linked Drug Pages (1)

Alvimopan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "89b02f3c-d8da-4b1f-9847-859c4efffabb", "openfda": {"unii": ["677C126AET"], "rxcui": ["799835"], "spl_set_id": ["59ef406b-79db-4efd-b993-08b937ac682b"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (0054-0668-82)  / 5 CAPSULE in 1 BLISTER PACK", "package_ndc": "0054-0668-82", "marketing_start_date": "20240206"}], "brand_name": "Alvimopan", "product_id": "0054-0668_89b02f3c-d8da-4b1f-9847-859c4efffabb", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "0054-0668", "generic_name": "Alvimopan", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alvimopan", "active_ingredients": [{"name": "ALVIMOPAN", "strength": "12 mg/1"}], "application_number": "ANDA217753", "marketing_category": "ANDA", "marketing_start_date": "20240206", "listing_expiration_date": "20261231"}