prochlorperazine edisylate

Generic: prochlorperazine edisylate

Labeler: avenacy inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine edisylate
Generic Name prochlorperazine edisylate
Labeler avenacy inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

prochlorperazine edisylate 5 mg/mL

Manufacturer
Avenacy Inc.

Identifiers & Regulatory

Product NDC 83634-778
Product ID 83634-778_d8b06d8a-15cf-4aaa-933b-76bf2b4b035a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204147
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634778
Hyphenated Format 83634-778

Supplemental Identifiers

RxCUI
2102949
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 ANDA204147 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (83634-778-02) / 2 mL in 1 VIAL (83634-778-41)
source: ndc

Packages (1)

83634-778-02 10 VIAL in 1 CARTON (83634-778-02) / 2 mL in 1 VIAL (83634-778-41)

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": "d8b06d8a-15cf-4aaa-933b-76bf2b4b035a", "openfda": {"unii": ["PG20W5VQZS"], "rxcui": ["2102949"], "spl_set_id": ["fd07a1a3-c0df-4926-9964-07348e45a5fd"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (83634-778-02)  / 2 mL in 1 VIAL (83634-778-41)", "package_ndc": "83634-778-02", "marketing_start_date": "20240601"}], "brand_name": "prochlorperazine edisylate", "product_id": "83634-778_d8b06d8a-15cf-4aaa-933b-76bf2b4b035a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "83634-778", "generic_name": "prochlorperazine edisylate", "labeler_name": "Avenacy Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "prochlorperazine edisylate", "active_ingredients": [{"name": "PROCHLORPERAZINE EDISYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA204147", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}