prochlorperazine maleate

Generic: prochlorperazine maleate

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine maleate
Generic Name prochlorperazine maleate
Labeler bionpharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prochlorperazine maleate 5 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-471
Product ID 69452-471_2cf363d6-b9e5-2c22-e063-6394a90a7649
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217478
Listing Expiration 2026-12-31
Marketing Start 2025-01-31

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452471
Hyphenated Format 69452-471

Supplemental Identifiers

RxCUI
198365 312635
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 ANDA217478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69452-471-20)
  • 1000 TABLET in 1 BOTTLE (69452-471-32)
source: ndc

Packages (2)

69452-471-20 100 TABLET in 1 BOTTLE (69452-471-20) 69452-471-32 1000 TABLET in 1 BOTTLE (69452-471-32)

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": "2cf363d6-b9e5-2c22-e063-6394a90a7649", "openfda": {"unii": ["I1T8O1JTL6"], "rxcui": ["198365", "312635"], "spl_set_id": ["2cf363d6-b9e4-2c22-e063-6394a90a7649"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69452-471-20)", "package_ndc": "69452-471-20", "marketing_start_date": "20250131"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69452-471-32)", "package_ndc": "69452-471-32", "marketing_start_date": "20250131"}], "brand_name": "PROCHLORPERAZINE MALEATE", "product_id": "69452-471_2cf363d6-b9e5-2c22-e063-6394a90a7649", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "69452-471", "generic_name": "Prochlorperazine Maleate", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROCHLORPERAZINE MALEATE", "active_ingredients": [{"name": "PROCHLORPERAZINE MALEATE", "strength": "5 mg/1"}], "application_number": "ANDA217478", "marketing_category": "ANDA", "marketing_start_date": "20250131", "listing_expiration_date": "20261231"}