prochlorperazine maleate

Generic: prochlorperazine maleate

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

Drug Facts

Product Profile

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

prochlorperazine maleate 10 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-689
Product ID 70954-689_f884dbf6-01ce-4862-bb21-bf41cce2109a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216202
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954689
Hyphenated Format 70954-689

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 ANDA216202 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (70954-689-10)
source: ndc

Packages (1)

70954-689-10 100 TABLET in 1 BOTTLE (70954-689-10)

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": "f884dbf6-01ce-4862-bb21-bf41cce2109a", "openfda": {"unii": ["I1T8O1JTL6"], "rxcui": ["198365", "312635"], "spl_set_id": ["50ce4381-94ef-49ff-8794-cfde0ee803b4"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (70954-689-10)", "package_ndc": "70954-689-10", "marketing_start_date": "20220801"}], "brand_name": "Prochlorperazine Maleate", "product_id": "70954-689_f884dbf6-01ce-4862-bb21-bf41cce2109a", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "70954-689", "generic_name": "Prochlorperazine Maleate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prochlorperazine Maleate", "active_ingredients": [{"name": "PROCHLORPERAZINE MALEATE", "strength": "10 mg/1"}], "application_number": "ANDA216202", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}