olanzapine

Generic: olanzapine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 15 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-528
Product ID 68084-528_186bfffc-1308-b7be-e063-6394a90a0d6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076133
Listing Expiration 2026-12-31
Marketing Start 2012-05-07

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084528
Hyphenated Format 68084-528

Supplemental Identifiers

RxCUI
283639 312077
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 ANDA076133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-528-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-528-11)
source: ndc

Packages (1)

68084-528-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-528-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-528-11)

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": "186bfffc-1308-b7be-e063-6394a90a0d6b", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["283639", "312077"], "spl_set_id": ["c0d705bf-b719-4c7b-b83d-c17d41cbbfad"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-528-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-528-11)", "package_ndc": "68084-528-01", "marketing_start_date": "20120507"}], "brand_name": "Olanzapine", "product_id": "68084-528_186bfffc-1308-b7be-e063-6394a90a0d6b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68084-528", "generic_name": "Olanzapine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA076133", "marketing_category": "ANDA", "marketing_start_date": "20120507", "listing_expiration_date": "20261231"}