prochlorperazine edisylate

Generic: prochlorperazine edisylate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine edisylate
Generic Name prochlorperazine edisylate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

prochlorperazine edisylate 5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-436
Product ID 68083-436_868ffb82-fd9b-4157-9e2c-1b76191ac1aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214107
Listing Expiration 2026-12-31
Marketing Start 2021-09-22

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083436
Hyphenated Format 68083-436

Supplemental Identifiers

RxCUI
2102949
UPC
0368083436018 0368083435103 0368083435257
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 ANDA214107 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-436-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

68083-436-01 1 VIAL in 1 CARTON (68083-436-01) / 10 mL in 1 VIAL

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": "868ffb82-fd9b-4157-9e2c-1b76191ac1aa", "openfda": {"upc": ["0368083436018", "0368083435103", "0368083435257"], "unii": ["PG20W5VQZS"], "rxcui": ["2102949"], "spl_set_id": ["a0fd3d58-7470-4d0f-9e6c-84e92c02a97f"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-436-01)  / 10 mL in 1 VIAL", "package_ndc": "68083-436-01", "marketing_start_date": "20210922"}], "brand_name": "Prochlorperazine Edisylate", "product_id": "68083-436_868ffb82-fd9b-4157-9e2c-1b76191ac1aa", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "68083-436", "generic_name": "Prochlorperazine Edisylate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prochlorperazine Edisylate", "active_ingredients": [{"name": "PROCHLORPERAZINE EDISYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA214107", "marketing_category": "ANDA", "marketing_start_date": "20210922", "listing_expiration_date": "20261231"}