olanzapine

Generic: olanzapine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-173
Product ID 67877-173_b4d4d6f0-2b78-4882-add2-7c6218270b7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202295
Listing Expiration 2026-12-31
Marketing Start 2012-01-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877173
Hyphenated Format 67877-173

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
UPC
0367877176321 0367877172323 0367877173306 0367877177304 0367877174013
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 ANDA202295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-173-01)
  • 1000 TABLET in 1 BOTTLE (67877-173-10)
  • 30 TABLET in 1 BOTTLE (67877-173-30)
  • 7 TABLET in 1 BOTTLE (67877-173-32)
  • 10 BLISTER PACK in 1 CARTON (67877-173-35) / 10 TABLET in 1 BLISTER PACK (67877-173-33)
  • 3 BLISTER PACK in 1 CARTON (67877-173-85) / 10 TABLET in 1 BLISTER PACK (67877-173-33)
source: ndc

Packages (6)

67877-173-01 100 TABLET in 1 BOTTLE (67877-173-01) 67877-173-10 1000 TABLET in 1 BOTTLE (67877-173-10) 67877-173-30 30 TABLET in 1 BOTTLE (67877-173-30) 67877-173-32 7 TABLET in 1 BOTTLE (67877-173-32) 67877-173-35 10 BLISTER PACK in 1 CARTON (67877-173-35) / 10 TABLET in 1 BLISTER PACK (67877-173-33) 67877-173-85 3 BLISTER PACK in 1 CARTON (67877-173-85) / 10 TABLET in 1 BLISTER PACK (67877-173-33)

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": "b4d4d6f0-2b78-4882-add2-7c6218270b7f", "openfda": {"nui": ["N0000175430"], "upc": ["0367877176321", "0367877172323", "0367877173306", "0367877177304", "0367877174013"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["e8626e68-088d-47ff-bf06-489a778815aa"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-173-01)", "package_ndc": "67877-173-01", "marketing_start_date": "20120101"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (67877-173-10)", "package_ndc": "67877-173-10", "marketing_start_date": "20120101"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-173-30)", "package_ndc": "67877-173-30", "marketing_start_date": "20120101"}, {"sample": false, "description": "7 TABLET in 1 BOTTLE (67877-173-32)", "package_ndc": "67877-173-32", "marketing_start_date": "20120101"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-173-35)  / 10 TABLET in 1 BLISTER PACK (67877-173-33)", "package_ndc": "67877-173-35", "marketing_start_date": "20120101"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (67877-173-85)  / 10 TABLET in 1 BLISTER PACK (67877-173-33)", "package_ndc": "67877-173-85", "marketing_start_date": "20120101"}], "brand_name": "Olanzapine", "product_id": "67877-173_b4d4d6f0-2b78-4882-add2-7c6218270b7f", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67877-173", "generic_name": "Olanzapine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA202295", "marketing_category": "ANDA", "marketing_start_date": "20120101", "listing_expiration_date": "20261231"}