Prochlorperazine Edisylate

Generic: Prochlorperazine Edisylate

Labeler: Hikma Pharmaceuticals USA Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Prochlorperazine Edisylate
Generic Name Prochlorperazine Edisylate
Labeler Hikma Pharmaceuticals USA Inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

PROCHLORPERAZINE EDISYLATE 5 mg/mL

Identifiers & Regulatory

Product NDC 0641-6225
Product ID 0641-6225_f3e74a48-3072-44f3-9370-ee8a4213585f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213630
Listing Expiration 2026-12-31
Marketing Start 2023-01-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416225
Hyphenated Format 0641-6225

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 Edisylate (source: ndc)
Generic Name Prochlorperazine Edisylate (source: ndc)
Application Number ANDA213630 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (0641-6225-10) / 2 mL in 1 SYRINGE (0641-6225-01)
source: ndc

Packages (1)

0641-6225-10 10 SYRINGE in 1 CARTON (0641-6225-10) / 2 mL in 1 SYRINGE (0641-6225-01)

Ingredients (1)

PROCHLORPERAZINE EDISYLATE (5 mg/mL)

Linked Drug Pages (1)

Prochlorperazine Edisylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "f3e74a48-3072-44f3-9370-ee8a4213585f", "openfda": {"unii": ["PG20W5VQZS"], "rxcui": ["2633008"], "spl_set_id": ["b3c5c1b7-310a-4658-bd01-b88b7334b591"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (0641-6225-10)  / 2 mL in 1 SYRINGE (0641-6225-01)", "package_ndc": "0641-6225-10", "marketing_start_date": "20230102"}], "brand_name": "Prochlorperazine Edisylate", "product_id": "0641-6225_f3e74a48-3072-44f3-9370-ee8a4213585f", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0641-6225", "generic_name": "Prochlorperazine Edisylate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prochlorperazine Edisylate", "active_ingredients": [{"name": "PROCHLORPERAZINE EDISYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA213630", "marketing_category": "ANDA", "marketing_start_date": "20230102", "listing_expiration_date": "20261231"}