olanzapine

Generic: olanzapine

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

Drug Facts

Product Profile

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

olanzapine 5 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-164
Product ID 43598-164_9f9b5830-1420-24fc-73be-4a040ccb22db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076255
Listing Expiration 2026-12-31
Marketing Start 2013-12-10

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598164
Hyphenated Format 43598-164

Supplemental Identifiers

RxCUI
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 ANDA076255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (43598-164-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (43598-164-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (43598-164-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (43598-164-30)
  • 10 BLISTER PACK in 1 CARTON (43598-164-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-164-79)
source: ndc

Packages (5)

43598-164-01 100 TABLET, FILM COATED in 1 BOTTLE (43598-164-01) 43598-164-05 500 TABLET, FILM COATED in 1 BOTTLE (43598-164-05) 43598-164-10 1000 TABLET, FILM COATED in 1 BOTTLE (43598-164-10) 43598-164-30 30 TABLET, FILM COATED in 1 BOTTLE (43598-164-30) 43598-164-78 10 BLISTER PACK in 1 CARTON (43598-164-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-164-79)

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": "9f9b5830-1420-24fc-73be-4a040ccb22db", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312078", "312079", "314154"], "spl_set_id": ["d474d5a9-d338-511d-5823-567c0a1bbf4d"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (43598-164-01)", "package_ndc": "43598-164-01", "marketing_start_date": "20131210"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43598-164-05)", "package_ndc": "43598-164-05", "marketing_start_date": "20131210"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (43598-164-10)", "package_ndc": "43598-164-10", "marketing_start_date": "20131210"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (43598-164-30)", "package_ndc": "43598-164-30", "marketing_start_date": "20131210"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (43598-164-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-164-79)", "package_ndc": "43598-164-78", "marketing_start_date": "20131210"}], "brand_name": "Olanzapine", "product_id": "43598-164_9f9b5830-1420-24fc-73be-4a040ccb22db", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "43598-164", "generic_name": "Olanzapine", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA076255", "marketing_category": "ANDA", "marketing_start_date": "20131210", "listing_expiration_date": "20261231"}