olanzapine

Generic: olanzapine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

olanzapine 10 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-564
Product ID 65862-564_e10b90de-4a0a-413e-a5f9-6978a183b568
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202050
Listing Expiration 2027-12-31
Marketing Start 2012-04-23

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862564
Hyphenated Format 65862-564

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
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 ANDA202050 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-564-01)
  • 10 BLISTER PACK in 1 CARTON (65862-564-10) / 10 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (65862-564-30)
  • 1000 TABLET in 1 BOTTLE (65862-564-99)
source: ndc

Packages (4)

65862-564-01 100 TABLET in 1 BOTTLE (65862-564-01) 65862-564-10 10 BLISTER PACK in 1 CARTON (65862-564-10) / 10 TABLET in 1 BLISTER PACK 65862-564-30 30 TABLET in 1 BOTTLE (65862-564-30) 65862-564-99 1000 TABLET in 1 BOTTLE (65862-564-99)

Ingredients (1)

olanzapine (10 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": "e10b90de-4a0a-413e-a5f9-6978a183b568", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["636665be-9d7e-443a-8134-e8cc47e6ba24"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-564-01)", "package_ndc": "65862-564-01", "marketing_start_date": "20120423"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-564-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "65862-564-10", "marketing_start_date": "20120423"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (65862-564-30)", "package_ndc": "65862-564-30", "marketing_start_date": "20120423"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65862-564-99)", "package_ndc": "65862-564-99", "marketing_start_date": "20120423"}], "brand_name": "Olanzapine", "product_id": "65862-564_e10b90de-4a0a-413e-a5f9-6978a183b568", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65862-564", "generic_name": "Olanzapine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/1"}], "application_number": "ANDA202050", "marketing_category": "ANDA", "marketing_start_date": "20120423", "listing_expiration_date": "20271231"}