alvimopan

Generic: alvimopan

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

Drug Facts

Product Profile

Brand Name alvimopan
Generic Name alvimopan
Labeler actavis pharma, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

alvimopan 12 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2312
Product ID 0591-2312_ef9ffdef-f019-4329-b6a4-658fa872d3b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208295
Listing Expiration 2026-12-31
Marketing Start 2020-12-01

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05912312
Hyphenated Format 0591-2312

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 ANDA208295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0591-2312-15) / 1 CAPSULE in 1 BLISTER PACK (0591-2312-45)
source: ndc

Packages (1)

0591-2312-15 30 BLISTER PACK in 1 CARTON (0591-2312-15) / 1 CAPSULE in 1 BLISTER PACK (0591-2312-45)

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": "ef9ffdef-f019-4329-b6a4-658fa872d3b8", "openfda": {"unii": ["677C126AET"], "rxcui": ["799835"], "spl_set_id": ["2a0645b4-daf8-421f-b987-a4e478843c5d"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0591-2312-15)  / 1 CAPSULE in 1 BLISTER PACK (0591-2312-45)", "package_ndc": "0591-2312-15", "marketing_start_date": "20201201"}], "brand_name": "Alvimopan", "product_id": "0591-2312_ef9ffdef-f019-4329-b6a4-658fa872d3b8", "dosage_form": "CAPSULE", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "0591-2312", "generic_name": "Alvimopan", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alvimopan", "active_ingredients": [{"name": "ALVIMOPAN", "strength": "12 mg/1"}], "application_number": "ANDA208295", "marketing_category": "ANDA", "marketing_start_date": "20201201", "listing_expiration_date": "20261231"}