olanzapine

Generic: olanzapine

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler northstar rxllc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 15 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-158
Product ID 72603-158_bfaf4fef-69a8-40e1-b995-899044ad4a39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202862
Listing Expiration 2026-12-31
Marketing Start 2014-08-22

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603158
Hyphenated Format 72603-158

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
UPC
0372603155013 0372603157024 0372603159035 0372603155037 0372603157031 0372603157017 0372603159011 0372603158014 0372603156010 0372603154023 0372603155020 0372603159028
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 ANDA202862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72603-158-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72603-158-02)
source: ndc

Packages (2)

72603-158-01 30 TABLET, FILM COATED in 1 BOTTLE (72603-158-01) 72603-158-02 1000 TABLET, FILM COATED in 1 BOTTLE (72603-158-02)

Ingredients (1)

olanzapine (15 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": "bfaf4fef-69a8-40e1-b995-899044ad4a39", "openfda": {"nui": ["N0000175430"], "upc": ["0372603155013", "0372603157024", "0372603159035", "0372603155037", "0372603157031", "0372603157017", "0372603159011", "0372603158014", "0372603156010", "0372603154023", "0372603155020", "0372603159028"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["ea3259d5-36ee-4ac9-b849-9625626e2187"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72603-158-01)", "package_ndc": "72603-158-01", "marketing_start_date": "20230705"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72603-158-02)", "package_ndc": "72603-158-02", "marketing_start_date": "20230705"}], "brand_name": "Olanzapine", "product_id": "72603-158_bfaf4fef-69a8-40e1-b995-899044ad4a39", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72603-158", "generic_name": "Olanzapine", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA202862", "marketing_category": "ANDA", "marketing_start_date": "20140822", "listing_expiration_date": "20261231"}