procainamide hydrochloride

Generic: procainamide hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name procainamide hydrochloride
Generic Name procainamide hydrochloride
Labeler remedyrepack inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

procainamide hydrochloride 100 mg/mL

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4208
Product ID 70518-4208_3ff5badd-ddd6-8f29-e063-6294a90aa9f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088636
Listing Expiration 2026-12-31
Marketing Start 2024-10-10

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184208
Hyphenated Format 70518-4208

Supplemental Identifiers

RxCUI
1862220
UNII
SI4064O0LX

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 ANDA088636 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 5 SYRINGE in 1 PACKAGE (70518-4208-0) / 10 mL in 1 SYRINGE (70518-4208-1)
source: ndc

Packages (1)

70518-4208-0 5 SYRINGE in 1 PACKAGE (70518-4208-0) / 10 mL in 1 SYRINGE (70518-4208-1)

Ingredients (1)

procainamide hydrochloride (100 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": "3ff5badd-ddd6-8f29-e063-6294a90aa9f0", "openfda": {"unii": ["SI4064O0LX"], "rxcui": ["1862220"], "spl_set_id": ["1ec3b767-66bb-4634-877e-71f70d501da0"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE in 1 PACKAGE (70518-4208-0)  / 10 mL in 1 SYRINGE (70518-4208-1)", "package_ndc": "70518-4208-0", "marketing_start_date": "20241010"}], "brand_name": "Procainamide Hydrochloride", "product_id": "70518-4208_3ff5badd-ddd6-8f29-e063-6294a90aa9f0", "dosage_form": "INJECTION", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "70518-4208", "generic_name": "Procainamide Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Procainamide Hydrochloride", "active_ingredients": [{"name": "PROCAINAMIDE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "ANDA088636", "marketing_category": "ANDA", "marketing_start_date": "20241010", "listing_expiration_date": "20261231"}