procainamide hydrochloride

Generic: procainamide hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name procainamide hydrochloride
Generic Name procainamide hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

procainamide hydrochloride 500 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-323
Product ID 25021-323_65bd5a24-3fbb-4264-b26f-5839143936db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218135
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021323
Hyphenated Format 25021-323

Supplemental Identifiers

RxCUI
857886 857962
UNII
SI4064O0LX

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 procainamide hydrochloride (source: ndc)
Generic Name procainamide hydrochloride (source: ndc)
Application Number ANDA218135 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-323-02) / 2 mL in 1 VIAL
source: ndc

Packages (1)

25021-323-02 10 VIAL in 1 CARTON (25021-323-02) / 2 mL in 1 VIAL

Ingredients (1)

procainamide hydrochloride (500 mg/mL)

Linked Drug Pages (1)

Procainamide Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "65bd5a24-3fbb-4264-b26f-5839143936db", "openfda": {"unii": ["SI4064O0LX"], "rxcui": ["857886", "857962"], "spl_set_id": ["358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-323-02)  / 2 mL in 1 VIAL", "package_ndc": "25021-323-02", "marketing_start_date": "20250115"}], "brand_name": "Procainamide Hydrochloride", "product_id": "25021-323_65bd5a24-3fbb-4264-b26f-5839143936db", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "25021-323", "generic_name": "Procainamide Hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Procainamide Hydrochloride", "active_ingredients": [{"name": "PROCAINAMIDE HYDROCHLORIDE", "strength": "500 mg/mL"}], "application_number": "ANDA218135", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}