prochlorperazine edisylate

Generic: prochlorperazine edisylate

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

prochlorperazine edisylate 5 mg/mL

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0351
Product ID 0713-0351_284f182c-9dde-805f-e063-6394a90a0f02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213626
Listing Expiration 2026-12-31
Marketing Start 2022-02-11

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130351
Hyphenated Format 0713-0351

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 ANDA213626 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (0713-0351-09) / 2 mL in 1 VIAL (0713-0351-02)
  • 25 VIAL in 1 PACKAGE (0713-0351-25) / 2 mL in 1 VIAL (0713-0351-02)
source: ndc

Packages (2)

0713-0351-09 10 VIAL in 1 PACKAGE (0713-0351-09) / 2 mL in 1 VIAL (0713-0351-02) 0713-0351-25 25 VIAL in 1 PACKAGE (0713-0351-25) / 2 mL in 1 VIAL (0713-0351-02)

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": "284f182c-9dde-805f-e063-6394a90a0f02", "openfda": {"unii": ["PG20W5VQZS"], "rxcui": ["2102949"], "spl_set_id": ["4687b9f5-2d67-4fe0-af4d-2415a42b5292"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (0713-0351-09)  / 2 mL in 1 VIAL (0713-0351-02)", "package_ndc": "0713-0351-09", "marketing_start_date": "20220211"}, {"sample": false, "description": "25 VIAL in 1 PACKAGE (0713-0351-25)  / 2 mL in 1 VIAL (0713-0351-02)", "package_ndc": "0713-0351-25", "marketing_start_date": "20220211"}], "brand_name": "Prochlorperazine Edisylate", "product_id": "0713-0351_284f182c-9dde-805f-e063-6394a90a0f02", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0713-0351", "generic_name": "Prochlorperazine Edisylate", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prochlorperazine Edisylate", "active_ingredients": [{"name": "PROCHLORPERAZINE EDISYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA213626", "marketing_category": "ANDA", "marketing_start_date": "20220211", "listing_expiration_date": "20261231"}