olanzapine

Generic: olanzapine

Labeler: jubilant cadista pharmacuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler jubilant cadista pharmacuticals inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Jubilant Cadista Pharmacuticals Inc.

Identifiers & Regulatory

Product NDC 59746-306
Product ID 59746-306_fddf60eb-156f-4e8c-9bad-3942d714fdce
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200221
Listing Expiration 2026-12-31
Marketing Start 2012-09-13

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59746306
Hyphenated Format 59746-306

Supplemental Identifiers

RxCUI
312076 314155 351107 351108
UPC
0359746307325 0359746306328 0359746309329 0359746308322
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 ANDA200221 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (59746-306-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-306-12)
source: ndc

Packages (1)

59746-306-32 3 BLISTER PACK in 1 CARTON (59746-306-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-306-12)

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": "fddf60eb-156f-4e8c-9bad-3942d714fdce", "openfda": {"nui": ["N0000175430"], "upc": ["0359746307325", "0359746306328", "0359746309329", "0359746308322"], "unii": ["N7U69T4SZR"], "rxcui": ["312076", "314155", "351107", "351108"], "spl_set_id": ["028aa88e-fa50-7aa8-cc0b-97c0c9a0357c"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Jubilant Cadista Pharmacuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (59746-306-32)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-306-12)", "package_ndc": "59746-306-32", "marketing_start_date": "20120913"}], "brand_name": "Olanzapine", "product_id": "59746-306_fddf60eb-156f-4e8c-9bad-3942d714fdce", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "59746-306", "generic_name": "Olanzapine", "labeler_name": "Jubilant Cadista Pharmacuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA200221", "marketing_category": "ANDA", "marketing_start_date": "20120913", "listing_expiration_date": "20261231"}