procainamide hydrochloride

Generic: procainamide hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name procainamide hydrochloride
Generic Name procainamide hydrochloride
Labeler propharma distribution
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

procainamide hydrochloride 100 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-399
Product ID 84549-399_3d5d9d6e-1f1d-7565-e063-6394a90a93e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088636
Listing Expiration 2026-12-31
Marketing Start 2016-12-21

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84549399
Hyphenated Format 84549-399

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
  • 10 mL in 1 SYRINGE (84549-399-05)
source: ndc

Packages (1)

84549-399-05 10 mL in 1 SYRINGE (84549-399-05)

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": "3d5d9d6e-1f1d-7565-e063-6394a90a93e7", "openfda": {"unii": ["SI4064O0LX"], "rxcui": ["1862220"], "spl_set_id": ["3d5d9d6e-1f1c-7565-e063-6394a90a93e7"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 SYRINGE (84549-399-05)", "package_ndc": "84549-399-05", "marketing_start_date": "20250901"}], "brand_name": "Procainamide Hydrochloride", "product_id": "84549-399_3d5d9d6e-1f1d-7565-e063-6394a90a93e7", "dosage_form": "INJECTION", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "84549-399", "generic_name": "Procainamide Hydrochloride", "labeler_name": "ProPharma Distribution", "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": "20161221", "listing_expiration_date": "20261231"}