olanzapine

Generic: olanzapine

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

olanzapine 10 mg/1

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-308
Product ID 55150-308_3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210968
Listing Expiration 2027-12-31
Marketing Start 2020-10-22

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150308
Hyphenated Format 55150-308

Supplemental Identifiers

RxCUI
485968
UPC
0355150308101 0355150308019
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 ANDA210968 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55150-308-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 55150-308-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

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": ["INTRAMUSCULAR"], "spl_id": "3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6", "openfda": {"nui": ["N0000175430"], "upc": ["0355150308101", "0355150308019"], "unii": ["N7U69T4SZR"], "rxcui": ["485968"], "spl_set_id": ["9c745e2e-89d3-44d4-906e-704705c33310"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-308-01", "marketing_start_date": "20201022"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-308-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-308-10", "marketing_start_date": "20201022"}], "brand_name": "OLANZAPINE", "product_id": "55150-308_3f2bc4a3-93fe-42c3-aa91-0d1b337b81a6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "55150-308", "generic_name": "OLANZAPINE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OLANZAPINE", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/1"}], "application_number": "ANDA210968", "marketing_category": "ANDA", "marketing_start_date": "20201022", "listing_expiration_date": "20271231"}