olanzapine

Generic: olanzapine

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

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler dr.reddy's laboratories limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 10 mg/1

Manufacturer
Dr.Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-263
Product ID 55111-263_ae2395b5-0918-65db-7001-41d52f121be7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076534
Listing Expiration 2026-12-31
Marketing Start 2011-10-24

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111263
Hyphenated Format 55111-263

Supplemental Identifiers

RxCUI
312076 314155 351107 351108
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 ANDA076534 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-263-79)
  • 3 BLISTER PACK in 1 CARTON (55111-263-81) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (2)

55111-263-79 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-263-79) 55111-263-81 3 BLISTER PACK in 1 CARTON (55111-263-81) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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": "ae2395b5-0918-65db-7001-41d52f121be7", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312076", "314155", "351107", "351108"], "spl_set_id": ["aff02cff-d079-bc82-6182-a24c4c6e09a6"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Dr.Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-263-79)", "package_ndc": "55111-263-79", "marketing_start_date": "20111024"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (55111-263-81)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "55111-263-81", "marketing_start_date": "20111024"}], "brand_name": "Olanzapine", "product_id": "55111-263_ae2395b5-0918-65db-7001-41d52f121be7", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "55111-263", "generic_name": "Olanzapine", "labeler_name": "Dr.Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/1"}], "application_number": "ANDA076534", "marketing_category": "ANDA", "marketing_start_date": "20111024", "listing_expiration_date": "20261231"}