zyprexa zydis

Generic: olanzapine

Labeler: h2-pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zyprexa zydis
Generic Name olanzapine
Labeler h2-pharma llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 15 mg/1

Manufacturer
H2-Pharma LLC

Identifiers & Regulatory

Product NDC 61269-652
Product ID 61269-652_40d4ed67-c51d-40d0-8a32-ecfdbf069f9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021086
Listing Expiration 2027-12-31
Marketing Start 2001-09-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61269652
Hyphenated Format 61269-652

Supplemental Identifiers

RxCUI
153046 153047 153048 200034 212405 261337 283639 284514 312076 312077 312078 312079 314154 314155 351107 351108 485968 545353 754503 754504 754505 754506
UPC
0361269633300 0361269635304 0361269634307 0361269630309 0361269632303 0361269631306
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 zyprexa zydis (source: ndc)
Generic Name olanzapine (source: ndc)
Application Number NDA021086 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 DOSE PACK in 1 CARTON (61269-652-35) / 1 BLISTER PACK in 1 DOSE PACK (61269-652-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (1)

61269-652-35 30 DOSE PACK in 1 CARTON (61269-652-35) / 1 BLISTER PACK in 1 DOSE PACK (61269-652-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

olanzapine (15 mg/1)

Linked Drug Pages (1)

Zyprexa, ZYPREXA Intramuscular, ZYPREXA Zydis ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40d4ed67-c51d-40d0-8a32-ecfdbf069f9a", "openfda": {"nui": ["N0000175430"], "upc": ["0361269633300", "0361269635304", "0361269634307", "0361269630309", "0361269632303", "0361269631306"], "unii": ["N7U69T4SZR"], "rxcui": ["153046", "153047", "153048", "200034", "212405", "261337", "283639", "284514", "312076", "312077", "312078", "312079", "314154", "314155", "351107", "351108", "485968", "545353", "754503", "754504", "754505", "754506"], "spl_set_id": ["b418946a-1ab4-4d89-a012-d94fc361a3c4"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["H2-Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 DOSE PACK in 1 CARTON (61269-652-35)  / 1 BLISTER PACK in 1 DOSE PACK (61269-652-01)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "61269-652-35", "marketing_start_date": "20010901"}], "brand_name": "ZYPREXA Zydis", "product_id": "61269-652_40d4ed67-c51d-40d0-8a32-ecfdbf069f9a", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "61269-652", "generic_name": "Olanzapine", "labeler_name": "H2-Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYPREXA", "brand_name_suffix": "Zydis", "active_ingredients": [{"name": "OLANZAPINE", "strength": "15 mg/1"}], "application_number": "NDA021086", "marketing_category": "NDA", "marketing_start_date": "20010901", "listing_expiration_date": "20271231"}