prochlorperazine edisylate

Generic: prochlorperazine edisylate

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name prochlorperazine edisylate
Generic Name prochlorperazine edisylate
Labeler somerset therapeutics, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

prochlorperazine edisylate 5 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-371
Product ID 70069-371_2d2a447e-bfc4-42dc-b581-31c224ad24b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212257
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069371
Hyphenated Format 70069-371

Supplemental Identifiers

RxCUI
2102949
UPC
0370069371015 0370069371251 0370069371107
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 ANDA212257 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (70069-371-25) / 2 mL in 1 VIAL (70069-371-01)
source: ndc

Packages (1)

Ingredients (1)

prochlorperazine edisylate (5 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "2d2a447e-bfc4-42dc-b581-31c224ad24b1", "openfda": {"upc": ["0370069371015", "0370069371251", "0370069371107"], "unii": ["PG20W5VQZS"], "rxcui": ["2102949"], "spl_set_id": ["d382e3d4-3175-42f2-b9eb-d9a7b97cbbfc"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (70069-371-25)  / 2 mL in 1 VIAL (70069-371-01)", "package_ndc": "70069-371-25", "marketing_start_date": "20241010"}], "brand_name": "Prochlorperazine Edisylate", "product_id": "70069-371_2d2a447e-bfc4-42dc-b581-31c224ad24b1", "dosage_form": "INJECTION", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "70069-371", "generic_name": "Prochlorperazine Edisylate", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prochlorperazine Edisylate", "active_ingredients": [{"name": "PROCHLORPERAZINE EDISYLATE", "strength": "5 mg/mL"}], "application_number": "ANDA212257", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}