prochlorperazine maleate

Generic: prochlorperazine maleate

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine maleate
Generic Name prochlorperazine maleate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

prochlorperazine maleate 10 mg/1

Manufacturer
GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-947
Product ID 68462-947_87ee1668-fd00-4e54-8c72-14ca91b94e0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216595
Listing Expiration 2027-12-31
Marketing Start 2025-05-28

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462947
Hyphenated Format 68462-947

Supplemental Identifiers

RxCUI
198365 312635
UPC
0368462947012
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 ANDA216595 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-947-01)
  • 1000 TABLET in 1 BOTTLE (68462-947-10)
source: ndc

Packages (2)

68462-947-01 100 TABLET in 1 BOTTLE (68462-947-01) 68462-947-10 1000 TABLET in 1 BOTTLE (68462-947-10)

Ingredients (1)

prochlorperazine maleate (10 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": "87ee1668-fd00-4e54-8c72-14ca91b94e0e", "openfda": {"upc": ["0368462947012"], "unii": ["I1T8O1JTL6"], "rxcui": ["198365", "312635"], "spl_set_id": ["9c806152-70d0-43eb-b183-b51b12b82b31"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-947-01)", "package_ndc": "68462-947-01", "marketing_start_date": "20250528"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68462-947-10)", "package_ndc": "68462-947-10", "marketing_start_date": "20250528"}], "brand_name": "PROCHLORPERAZINE MALEATE", "product_id": "68462-947_87ee1668-fd00-4e54-8c72-14ca91b94e0e", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68462-947", "generic_name": "PROCHLORPERAZINE MALEATE", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROCHLORPERAZINE MALEATE", "active_ingredients": [{"name": "PROCHLORPERAZINE MALEATE", "strength": "10 mg/1"}], "application_number": "ANDA216595", "marketing_category": "ANDA", "marketing_start_date": "20250528", "listing_expiration_date": "20271231"}