prochlorperazine maleate

Generic: prochlorperazine maleate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine maleate
Generic Name prochlorperazine maleate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prochlorperazine maleate 10 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-518
Product ID 72789-518_4603a67f-05af-5931-e063-6394a90afcf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218912
Listing Expiration 2026-12-31
Marketing Start 2025-07-28

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789518
Hyphenated Format 72789-518

Supplemental Identifiers

RxCUI
198365 312635
UPC
0372789517902
UNII
I1T8O1JTL6

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
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-01)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-15)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-90)
source: ndc

Packages (3)

Ingredients (1)

prochlorperazine maleate (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4603a67f-05af-5931-e063-6394a90afcf3", "openfda": {"upc": ["0372789517902"], "unii": ["I1T8O1JTL6"], "rxcui": ["198365", "312635"], "spl_set_id": ["3b022837-0fcc-d38a-e063-6394a90a0f7f"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-01)", "package_ndc": "72789-518-01", "marketing_start_date": "20250728"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-15)", "package_ndc": "72789-518-15", "marketing_start_date": "20251215"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-90)", "package_ndc": "72789-518-90", "marketing_start_date": "20250728"}], "brand_name": "PROCHLORPERAZINE MALEATE", "product_id": "72789-518_4603a67f-05af-5931-e063-6394a90afcf3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "72789-518", "generic_name": "PROCHLORPERAZINE MALEATE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROCHLORPERAZINE MALEATE", "active_ingredients": [{"name": "PROCHLORPERAZINE MALEATE", "strength": "10 mg/1"}], "application_number": "ANDA218912", "marketing_category": "ANDA", "marketing_start_date": "20250728", "listing_expiration_date": "20261231"}