olanzapine

Generic: olanzapine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 20 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-341
Product ID 72789-341_31f578dc-776c-d6fa-e063-6394a90a0b26
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 72789341
Hyphenated Format 72789-341

Supplemental Identifiers

RxCUI
283639
UPC
0372789341903
UNII
N7U69T4SZR
NUI
N0000175430

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
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-341-90)
source: ndc

Packages (1)

Ingredients (1)

olanzapine (20 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "31f578dc-776c-d6fa-e063-6394a90a0b26", "openfda": {"nui": ["N0000175430"], "upc": ["0372789341903"], "unii": ["N7U69T4SZR"], "rxcui": ["283639"], "spl_set_id": ["b6f0b2e2-3cbd-4564-8b3e-f811589af275"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-341-90)", "package_ndc": "72789-341-90", "marketing_start_date": "20230801"}], "brand_name": "Olanzapine", "product_id": "72789-341_31f578dc-776c-d6fa-e063-6394a90a0b26", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72789-341", "generic_name": "Olanzapine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "20 mg/1"}], "application_number": "ANDA202862", "marketing_category": "ANDA", "marketing_start_date": "20140822", "listing_expiration_date": "20261231"}