olanzapine

Generic: olanzapine

Labeler: dr. reddy's laboratories ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler dr. reddy's laboratories ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 20 mg/1

Manufacturer
Dr. Reddy's Laboratories Ltd.

Identifiers & Regulatory

Product NDC 55111-168
Product ID 55111-168_e0d25a13-d2e2-0299-98bb-4d523d75cb76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076133
Listing Expiration 2026-12-31
Marketing Start 2012-04-23

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111168
Hyphenated Format 55111-168

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (55111-168-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (55111-168-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-168-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (55111-168-60)
  • 10 BLISTER PACK in 1 CARTON (55111-168-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-168-79)
source: ndc

Packages (5)

55111-168-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-168-01) 55111-168-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-168-05) 55111-168-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-168-30) 55111-168-60 60 TABLET, FILM COATED in 1 BOTTLE (55111-168-60) 55111-168-78 10 BLISTER PACK in 1 CARTON (55111-168-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-168-79)

Ingredients (1)

olanzapine (20 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": "e0d25a13-d2e2-0299-98bb-4d523d75cb76", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["283639", "312077"], "spl_set_id": ["a4c525da-c2f6-b804-af49-601295922254"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (55111-168-01)", "package_ndc": "55111-168-01", "marketing_start_date": "20120423"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-168-05)", "package_ndc": "55111-168-05", "marketing_start_date": "20120423"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-168-30)", "package_ndc": "55111-168-30", "marketing_start_date": "20120423"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (55111-168-60)", "package_ndc": "55111-168-60", "marketing_start_date": "20120423"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-168-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-168-79)", "package_ndc": "55111-168-78", "marketing_start_date": "20120423"}], "brand_name": "Olanzapine", "product_id": "55111-168_e0d25a13-d2e2-0299-98bb-4d523d75cb76", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "55111-168", "generic_name": "Olanzapine", "labeler_name": "Dr. Reddy's Laboratories Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "20 mg/1"}], "application_number": "ANDA076133", "marketing_category": "ANDA", "marketing_start_date": "20120423", "listing_expiration_date": "20261231"}