prochlorperazine edisylate

Generic: prochlorperazine edisylate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

prochlorperazine edisylate 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6135
Product ID 0641-6135_6ffbbb71-5711-43b7-beb5-5ccfb6128cb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089903
Listing Expiration 2026-12-31
Marketing Start 1989-08-29

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416135
Hyphenated Format 0641-6135

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 ANDA089903 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6135-25) / 2 mL in 1 VIAL (0641-6135-01)
source: ndc

Packages (1)

0641-6135-25 25 VIAL in 1 CARTON (0641-6135-25) / 2 mL in 1 VIAL (0641-6135-01)

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": "6ffbbb71-5711-43b7-beb5-5ccfb6128cb5", "openfda": {"unii": ["PG20W5VQZS"], "rxcui": ["314192"], "spl_set_id": ["baf59816-7577-4652-b065-fb6de9e54569"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6135-25)  / 2 mL in 1 VIAL (0641-6135-01)", "package_ndc": "0641-6135-25", "marketing_start_date": "19890829"}], "brand_name": "Prochlorperazine Edisylate", "product_id": "0641-6135_6ffbbb71-5711-43b7-beb5-5ccfb6128cb5", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "0641-6135", "generic_name": "Prochlorperazine Edisylate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prochlorperazine Edisylate", "active_ingredients": [{"name": "PROCHLORPERAZINE EDISYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA089903", "marketing_category": "ANDA", "marketing_start_date": "19890829", "listing_expiration_date": "20261231"}