loxapine

Generic: loxapine

Labeler: elite laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loxapine
Generic Name loxapine
Labeler elite laboratories, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

loxapine succinate 10 mg/1

Manufacturer
Elite Laboratories, Inc.

Identifiers & Regulatory

Product NDC 64850-891
Product ID 64850-891_538b7d03-c464-465d-b690-9701c14cf580
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076868
Listing Expiration 2026-12-31
Marketing Start 2020-01-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64850891
Hyphenated Format 64850-891

Supplemental Identifiers

RxCUI
311385 311386 314075 314078
UPC
0364850890014 0364850893015 0364850892018 0364850891011
UNII
X59SG0MRYU

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 loxapine (source: ndc)
Generic Name loxapine (source: ndc)
Application Number ANDA076868 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (64850-891-01)
source: ndc

Packages (1)

Ingredients (1)

loxapine succinate (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "538b7d03-c464-465d-b690-9701c14cf580", "openfda": {"upc": ["0364850890014", "0364850893015", "0364850892018", "0364850891011"], "unii": ["X59SG0MRYU"], "rxcui": ["311385", "311386", "314075", "314078"], "spl_set_id": ["a0cc7bb6-075f-47d1-8935-eb77a29d8c45"], "manufacturer_name": ["Elite Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (64850-891-01)", "package_ndc": "64850-891-01", "marketing_start_date": "20200127"}], "brand_name": "Loxapine", "product_id": "64850-891_538b7d03-c464-465d-b690-9701c14cf580", "dosage_form": "CAPSULE", "product_ndc": "64850-891", "generic_name": "Loxapine", "labeler_name": "Elite Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loxapine", "active_ingredients": [{"name": "LOXAPINE SUCCINATE", "strength": "10 mg/1"}], "application_number": "ANDA076868", "marketing_category": "ANDA", "marketing_start_date": "20200127", "listing_expiration_date": "20261231"}