olanzapine

Generic: olanzapine

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler cadila pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

olanzapine 15 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-077
Product ID 71209-077_a7f753c2-1d2b-4b4f-b0e5-250bf951e7c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210022
Listing Expiration 2026-12-31
Marketing Start 2019-02-13

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209077
Hyphenated Format 71209-077

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
UPC
0371209073011 0371209076012 0371209078115 0371209077019 0371209074018 0371209075114 0371209073110 0371209076111 0371209074117
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 ANDA210022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71209-077-01)
  • 100 TABLET in 1 BOTTLE (71209-077-05)
  • 500 TABLET in 1 BOTTLE (71209-077-10)
  • 1000 TABLET in 1 BOTTLE (71209-077-11)
source: ndc

Packages (4)

71209-077-01 30 TABLET in 1 BOTTLE (71209-077-01) 71209-077-05 100 TABLET in 1 BOTTLE (71209-077-05) 71209-077-10 500 TABLET in 1 BOTTLE (71209-077-10) 71209-077-11 1000 TABLET in 1 BOTTLE (71209-077-11)

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": "a7f753c2-1d2b-4b4f-b0e5-250bf951e7c6", "openfda": {"nui": ["N0000175430"], "upc": ["0371209073011", "0371209076012", "0371209078115", "0371209077019", "0371209074018", "0371209075114", "0371209073110", "0371209076111", "0371209074117"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["2ae07ad4-4e58-4740-9f02-035ec061fefc"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71209-077-01)", "package_ndc": "71209-077-01", "marketing_start_date": "20190213"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71209-077-05)", "package_ndc": "71209-077-05", "marketing_start_date": "20231004"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (71209-077-10)", "package_ndc": "71209-077-10", "marketing_start_date": "20231004"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (71209-077-11)", "package_ndc": "71209-077-11", "marketing_start_date": "20190213"}], "brand_name": "Olanzapine", "product_id": "71209-077_a7f753c2-1d2b-4b4f-b0e5-250bf951e7c6", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71209-077", "generic_name": "Olanzapine", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA210022", "marketing_category": "ANDA", "marketing_start_date": "20190213", "listing_expiration_date": "20261231"}