olanzapine

Generic: olanzapine

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler strides pharma science limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-172
Product ID 64380-172_4b3cec46-acb7-4072-b226-d5c7c06b33b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078109
Listing Expiration 2026-12-31
Marketing Start 2022-04-11

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380172
Hyphenated Format 64380-172

Supplemental Identifiers

RxCUI
312076 314155 351107 351108
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 ANDA078109 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (64380-172-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (64380-172-01)
source: ndc

Packages (1)

64380-172-02 3 BLISTER PACK in 1 CARTON (64380-172-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (64380-172-01)

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": "4b3cec46-acb7-4072-b226-d5c7c06b33b8", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312076", "314155", "351107", "351108"], "spl_set_id": ["979c3212-36e8-4287-aace-bef0875188d7"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (64380-172-02)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (64380-172-01)", "package_ndc": "64380-172-02", "marketing_start_date": "20220411"}], "brand_name": "Olanzapine", "product_id": "64380-172_4b3cec46-acb7-4072-b226-d5c7c06b33b8", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "64380-172", "generic_name": "olanzapine", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA078109", "marketing_category": "ANDA", "marketing_start_date": "20220411", "listing_expiration_date": "20261231"}