procainamide hydrochloride

Generic: procainamide hydrochloride

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

Drug Facts

Product Profile

Brand Name procainamide hydrochloride
Generic Name procainamide hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

procainamide hydrochloride 500 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-604
Product ID 68083-604_e8e25e4b-14ce-40cb-85d9-4cc78ca9e807
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218135
Listing Expiration 2026-12-31
Marketing Start 2024-07-22

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083604
Hyphenated Format 68083-604

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
  • 25 VIAL, MULTI-DOSE in 1 CASE (68083-604-25) / 2 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

68083-604-25 25 VIAL, MULTI-DOSE in 1 CASE (68083-604-25) / 2 mL in 1 VIAL, MULTI-DOSE

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": "e8e25e4b-14ce-40cb-85d9-4cc78ca9e807", "openfda": {"unii": ["SI4064O0LX"], "rxcui": ["857886", "857962"], "spl_set_id": ["ffde440f-7ad7-434c-bcd2-9bd8ff16d204"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CASE (68083-604-25)  / 2 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "68083-604-25", "marketing_start_date": "20240722"}], "brand_name": "Procainamide Hydrochloride", "product_id": "68083-604_e8e25e4b-14ce-40cb-85d9-4cc78ca9e807", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "68083-604", "generic_name": "Procainamide Hydrochloride", "labeler_name": "Gland Pharma Limited", "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": "20240722", "listing_expiration_date": "20261231"}