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, FILM COATED
Routes
ORAL
Active Ingredients

prochlorperazine maleate 5 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-309
Product ID 69452-309_2f9f880c-a70d-317b-e063-6294a90a2280
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217478
Listing Expiration 2026-12-31
Marketing Start 2023-09-13

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452309
Hyphenated Format 69452-309

Supplemental Identifiers

RxCUI
198365 312635
UPC
0369452310205 0369452309209
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, FILM COATED in 1 BOTTLE (69452-309-20)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69452-309-32)
source: ndc

Packages (2)

69452-309-20 100 TABLET, FILM COATED in 1 BOTTLE (69452-309-20) 69452-309-32 1000 TABLET, FILM COATED in 1 BOTTLE (69452-309-32)

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": "2f9f880c-a70d-317b-e063-6294a90a2280", "openfda": {"upc": ["0369452310205", "0369452309209"], "unii": ["I1T8O1JTL6"], "rxcui": ["198365", "312635"], "spl_set_id": ["052d351a-978b-6fc3-e063-6294a90aef55"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69452-309-20)", "package_ndc": "69452-309-20", "marketing_start_date": "20230913"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69452-309-32)", "package_ndc": "69452-309-32", "marketing_start_date": "20230913"}], "brand_name": "PROCHLORPERAZINE MALEATE", "product_id": "69452-309_2f9f880c-a70d-317b-e063-6294a90a2280", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "69452-309", "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": "20230913", "listing_expiration_date": "20261231"}