prochlorperazine edisylate

Generic: prochlorperazine edisylate

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine edisylate
Generic Name prochlorperazine edisylate
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

prochlorperazine edisylate 5 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-640
Product ID 67457-640_c2a1e04b-1654-456c-a66d-8ee1f877b034
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210710
Listing Expiration 2026-12-31
Marketing Start 2019-04-03

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457640
Hyphenated Format 67457-640

Supplemental Identifiers

RxCUI
314192
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 ANDA210710 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (67457-640-02) / 2 mL in 1 VIAL (67457-640-00)
  • 10 VIAL in 1 CARTON (67457-640-99) / 2 mL in 1 VIAL (67457-640-00)
source: ndc

Packages (2)

67457-640-02 25 VIAL in 1 CARTON (67457-640-02) / 2 mL in 1 VIAL (67457-640-00) 67457-640-99 10 VIAL in 1 CARTON (67457-640-99) / 2 mL in 1 VIAL (67457-640-00)

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": "c2a1e04b-1654-456c-a66d-8ee1f877b034", "openfda": {"unii": ["PG20W5VQZS"], "rxcui": ["314192"], "spl_set_id": ["185c1647-06ea-401e-ad1d-8727d77eb827"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (67457-640-02)  / 2 mL in 1 VIAL (67457-640-00)", "package_ndc": "67457-640-02", "marketing_start_date": "20190403"}, {"sample": false, "description": "10 VIAL in 1 CARTON (67457-640-99)  / 2 mL in 1 VIAL (67457-640-00)", "package_ndc": "67457-640-99", "marketing_start_date": "20190403"}], "brand_name": "prochlorperazine edisylate", "product_id": "67457-640_c2a1e04b-1654-456c-a66d-8ee1f877b034", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "67457-640", "generic_name": "prochlorperazine edisylate", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prochlorperazine edisylate", "active_ingredients": [{"name": "PROCHLORPERAZINE EDISYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA210710", "marketing_category": "ANDA", "marketing_start_date": "20190403", "listing_expiration_date": "20261231"}