olanzapine

Generic: olanzapine

Labeler: modavar pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler modavar pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

olanzapine 10 mg/1

Manufacturer
Modavar Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72241-054
Product ID 72241-054_46c3d805-c651-4086-ae20-b6ef6788b840
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210022
Listing Expiration 2026-12-31
Marketing Start 2023-02-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72241054
Hyphenated Format 72241-054

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
UPC
0372241055225 0372241056222 0372241056116 0372241054112 0372241052118 0372241051111 0372241053115
UNII
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 olanzapine (source: ndc)
Generic Name olanzapine (source: ndc)
Application Number ANDA210022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72241-054-05)
  • 500 TABLET in 1 BOTTLE (72241-054-10)
  • 1000 TABLET in 1 BOTTLE (72241-054-11)
  • 30 TABLET in 1 BOTTLE (72241-054-22)
source: ndc

Packages (4)

72241-054-05 100 TABLET in 1 BOTTLE (72241-054-05) 72241-054-10 500 TABLET in 1 BOTTLE (72241-054-10) 72241-054-11 1000 TABLET in 1 BOTTLE (72241-054-11) 72241-054-22 30 TABLET in 1 BOTTLE (72241-054-22)

Ingredients (1)

olanzapine (10 mg/1)

Linked Drug Pages (1)

Olanzapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46c3d805-c651-4086-ae20-b6ef6788b840", "openfda": {"nui": ["N0000175430"], "upc": ["0372241055225", "0372241056222", "0372241056116", "0372241054112", "0372241052118", "0372241051111", "0372241053115"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["f0943b4e-6bdc-48c1-8ecd-39cf732e16f5"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Modavar Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72241-054-05)", "package_ndc": "72241-054-05", "marketing_start_date": "20240117"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72241-054-10)", "package_ndc": "72241-054-10", "marketing_start_date": "20240117"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (72241-054-11)", "package_ndc": "72241-054-11", "marketing_start_date": "20240117"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72241-054-22)", "package_ndc": "72241-054-22", "marketing_start_date": "20240117"}], "brand_name": "Olanzapine", "product_id": "72241-054_46c3d805-c651-4086-ae20-b6ef6788b840", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72241-054", "generic_name": "Olanzapine", "labeler_name": "Modavar Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/1"}], "application_number": "ANDA210022", "marketing_category": "ANDA", "marketing_start_date": "20230227", "listing_expiration_date": "20261231"}