prochlorperazine maleate

Generic: prochlorperazine maleate

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine maleate
Generic Name prochlorperazine maleate
Labeler leading pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prochlorperazine maleate 5 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-265
Product ID 69315-265_e9585ce8-2433-4d85-ab3a-c544d7cb1532
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218912
Listing Expiration 2026-12-31
Marketing Start 2025-06-25

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315265
Hyphenated Format 69315-265

Supplemental Identifiers

RxCUI
198365 312635
UPC
0369315265017 0369315266014
UNII
I1T8O1JTL6

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 prochlorperazine maleate (source: ndc)
Generic Name prochlorperazine maleate (source: ndc)
Application Number ANDA218912 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69315-265-01)
source: ndc

Packages (1)

69315-265-01 100 TABLET, FILM COATED in 1 BOTTLE (69315-265-01)

Ingredients (1)

prochlorperazine maleate (5 mg/1)

Linked Drug Pages (1)

PROCHLORPERAZINE MALEATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e9585ce8-2433-4d85-ab3a-c544d7cb1532", "openfda": {"upc": ["0369315265017", "0369315266014"], "unii": ["I1T8O1JTL6"], "rxcui": ["198365", "312635"], "spl_set_id": ["c93494ef-c510-4e46-a1b1-362624200223"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69315-265-01)", "package_ndc": "69315-265-01", "marketing_start_date": "20250625"}], "brand_name": "PROCHLORPERAZINE MALEATE", "product_id": "69315-265_e9585ce8-2433-4d85-ab3a-c544d7cb1532", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "69315-265", "generic_name": "PROCHLORPERAZINE MALEATE", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROCHLORPERAZINE MALEATE", "active_ingredients": [{"name": "PROCHLORPERAZINE MALEATE", "strength": "5 mg/1"}], "application_number": "ANDA218912", "marketing_category": "ANDA", "marketing_start_date": "20250625", "listing_expiration_date": "20261231"}