prochlorperazine maleate

Generic: prochlorperazine maleate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine maleate
Generic Name prochlorperazine maleate
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

prochlorperazine maleate 5 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2038
Product ID 60219-2038_1ecda8a1-7680-41a0-8b4f-00c3c4ef9b14
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216598
Listing Expiration 2026-12-31
Marketing Start 2023-04-21

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602192038
Hyphenated Format 60219-2038

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 ANDA216598 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-1)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-7)
source: ndc

Packages (2)

60219-2038-1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-1) 60219-2038-7 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-7)

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": "1ecda8a1-7680-41a0-8b4f-00c3c4ef9b14", "openfda": {"unii": ["I1T8O1JTL6"], "rxcui": ["198365", "312635"], "spl_set_id": ["a2a48790-0634-4b46-b362-98b7c252836f"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-1)", "package_ndc": "60219-2038-1", "marketing_start_date": "20230421"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-2038-7)", "package_ndc": "60219-2038-7", "marketing_start_date": "20230421"}], "brand_name": "prochlorperazine maleate", "product_id": "60219-2038_1ecda8a1-7680-41a0-8b4f-00c3c4ef9b14", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "60219-2038", "generic_name": "prochlorperazine maleate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prochlorperazine maleate", "active_ingredients": [{"name": "PROCHLORPERAZINE MALEATE", "strength": "5 mg/1"}], "application_number": "ANDA216598", "marketing_category": "ANDA", "marketing_start_date": "20230421", "listing_expiration_date": "20261231"}