prochlorperazine edisylate

Generic: prochlorperazine edisylate

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine edisylate
Generic Name prochlorperazine edisylate
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

prochlorperazine edisylate 5 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-119
Product ID 65145-119_1e5918a5-cdeb-4685-abaf-7bea684d16aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214379
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145119
Hyphenated Format 65145-119

Supplemental Identifiers

RxCUI
2102949
UPC
0365145119018
UNII
PG20W5VQZS

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 edisylate (source: ndc)
Generic Name prochlorperazine edisylate (source: ndc)
Application Number ANDA214379 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (65145-119-10) / 2 mL in 1 VIAL (65145-119-01)
source: ndc

Packages (1)

65145-119-10 10 VIAL in 1 CARTON (65145-119-10) / 2 mL in 1 VIAL (65145-119-01)

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": "1e5918a5-cdeb-4685-abaf-7bea684d16aa", "openfda": {"upc": ["0365145119018"], "unii": ["PG20W5VQZS"], "rxcui": ["2102949"], "spl_set_id": ["29f0e68d-4653-472d-bd86-e87a8e2cb529"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (65145-119-10)  / 2 mL in 1 VIAL (65145-119-01)", "package_ndc": "65145-119-10", "marketing_start_date": "20241010"}], "brand_name": "Prochlorperazine Edisylate", "product_id": "65145-119_1e5918a5-cdeb-4685-abaf-7bea684d16aa", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "65145-119", "generic_name": "Prochlorperazine Edisylate", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prochlorperazine Edisylate", "active_ingredients": [{"name": "PROCHLORPERAZINE EDISYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA214379", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}