lybalvi

Generic: olanzapine and samidorphan l-malate

Labeler: alkermes, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lybalvi
Generic Name olanzapine and samidorphan l-malate
Labeler alkermes, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1, samidorphan l-malate 10 mg/1

Manufacturer
Alkermes, Inc.

Identifiers & Regulatory

Product NDC 65757-651
Product ID 65757-651_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213378
Listing Expiration 2027-12-31
Marketing Start 2021-09-20

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65757651
Hyphenated Format 65757-651

Supplemental Identifiers

RxCUI
2570392 2570398 2570399 2570401 2570402 2570404 2570405 2570407
UNII
0AJQ5N56E0 N7U69T4SZR
NUI
N0000175430

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 lybalvi (source: ndc)
Generic Name olanzapine and samidorphan l-malate (source: ndc)
Application Number NDA213378 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65757-651-42) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

65757-651-41 1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE 65757-651-42 1 BOTTLE in 1 CARTON (65757-651-42) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

olanzapine (5 mg/1) samidorphan l-malate (10 mg/1)

Linked Drug Pages (1)

LYBALVI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44ae69cc-b9a6-4658-90fa-1dbef1e97eb4", "openfda": {"nui": ["N0000175430"], "unii": ["0AJQ5N56E0", "N7U69T4SZR"], "rxcui": ["2570392", "2570398", "2570399", "2570401", "2570402", "2570404", "2570405", "2570407"], "spl_set_id": ["32ffddd1-4e2b-45d9-9b36-bb730167ec80"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Alkermes, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (65757-651-41)  / 7 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "65757-651-41", "marketing_start_date": "20210920"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65757-651-42)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "65757-651-42", "marketing_start_date": "20210920"}], "brand_name": "LYBALVI", "product_id": "65757-651_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]", "Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "65757-651", "generic_name": "olanzapine and samidorphan L-malate", "labeler_name": "Alkermes, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LYBALVI", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}, {"name": "SAMIDORPHAN L-MALATE", "strength": "10 mg/1"}], "application_number": "NDA213378", "marketing_category": "NDA", "marketing_start_date": "20210920", "listing_expiration_date": "20271231"}