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 5 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-460
Product ID 72789-460_3840298a-c3c2-01b5-e063-6394a90a0a60
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076255
Listing Expiration 2026-12-31
Marketing Start 2013-12-10

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789460
Hyphenated Format 72789-460

Supplemental Identifiers

RxCUI
312078
UPC
0372789460147
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 ANDA076255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-460-14)
source: ndc

Packages (1)

72789-460-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-460-14)

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": "3840298a-c3c2-01b5-e063-6394a90a0a60", "openfda": {"nui": ["N0000175430"], "upc": ["0372789460147"], "unii": ["N7U69T4SZR"], "rxcui": ["312078"], "spl_set_id": ["10043041-a632-4e57-bc08-37216dea8546"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-460-14)", "package_ndc": "72789-460-14", "marketing_start_date": "20241220"}], "brand_name": "Olanzapine", "product_id": "72789-460_3840298a-c3c2-01b5-e063-6394a90a0a60", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72789-460", "generic_name": "Olanzapine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA076255", "marketing_category": "ANDA", "marketing_start_date": "20131210", "listing_expiration_date": "20261231"}