olanzapine

Generic: olanzapine

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler qilu pharmaceutical co., ltd.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0562
Product ID 67184-0562_69558fe2-90b3-411a-89bb-2405d37d4998
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204319
Listing Expiration 2026-12-31
Marketing Start 2016-01-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 671840562
Hyphenated Format 67184-0562

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
UPC
0367184056415
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 ANDA204319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Olanzapine tablets, USP 2.5 mg, 5 mg, 7.5 mg, and 10 mg are white, round, unscored, film-coated tablets, debossed with tablet number on one side and plain on the other side. Olanzapine tablets, USP 15 mg are blue, elliptical, unscored, film-coated tablets, debossed with tablet number on one side and plain on the other side. Olanzapine tablets, USP 20 mg are pink, elliptical, unscored, film-coated tablets, debossed with tablet number on one side and plain on the other side. The tablets are available as follows: TABLET STRENGTH 2.5 mg 5 mg 7.5 mg 10 mg 10 mg 20 mg Identification 11 12 13 14 15 17 NDC codes: Bottle 30 NDC 67184-0561-1 NDC 67184-0562-1 NDC 67184-0563-1 NDC 67184-0564-1 NDC 67184-0565-1 NDC 67184-0566-1 Bottle 90 NDC 67184-0561-6 NDC 67184-0562-6 NDC 67184-0563-6 NDC 67184-0564-6 NDC 67184-0565-6 NDC 67184-0566-6 Bottle 100 NDC 67184-0561-2 NDC 67184-0562-2 NDC 67184-0563-2 NDC 67184-0564-2 NDC 67184-0565-2 NDC 67184-0566-2 Bottle 500 NDC 67184-0561-7 NDC 67184-0562-7 NDC 67184-0563-7 NDC 67184-0564-7 NDC 67184-0565-7 NDC 67184-0566-7 Bottle 600 - - - NDC 67184-0564-5 - NDC 67184-0566-5 Bottle 800 - - NDC 67184-0563-4 - NDC 67184-0565-4 - Bottle 1000 NDC 67184-0561-3 NDC 67184-0562-3 - - - - 16.2 Storage and Handling Store olanzapine tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ see USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect olanzapine tablets from light and moisture.
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2.5 mg (30 Tablets Bottle) NDC 67184- 0561 -1 30 Tablets Olanzapine Tablets, USP 2.5 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx only fig-1
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30 Tablets Bottle) NDC 67184 -0562- 1 30 Tablets Olanzapine Tablets, USP 5 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx only fig-2
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 7.5 mg (30 Tablets Bottle) NDC 67184- 0563 -1 30 Tablets Olanzapine Tablets, USP 7.5 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx only fig3
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Bottle) NDC 67184 -0564-1 30 Tablets Olanzapine Tablets, USP 10 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx only fig-4
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 mg (30 Tablets Bottle) NDC 67184 -0565-1 30 Tablets Olanzapine Tablets, USP 15 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx only fig-5
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (30 Tablets Bottle) NDC 67184 -0566- 1 30 Tablets Olanzapine Tablets, USP 20 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Rx only fig-6
source: label

Packages (0)

No package records.

Ingredients (1)

olanzapine (5 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": "69558fe2-90b3-411a-89bb-2405d37d4998", "openfda": {"nui": ["N0000175430"], "upc": ["0367184056415"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["6077f5c4-01d7-4c1d-97a0-cb859f98ce68"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Olanzapine", "product_id": "67184-0562_69558fe2-90b3-411a-89bb-2405d37d4998", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67184-0562", "generic_name": "Olanzapine", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA204319", "marketing_category": "ANDA", "marketing_start_date": "20160127", "listing_expiration_date": "20261231"}