procainamide hydrochloride

Generic: procainamide hydrochloride

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name procainamide hydrochloride
Generic Name procainamide hydrochloride
Labeler international medication systems, limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

procainamide hydrochloride 100 mg/mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-3399
Product ID 76329-3399_f3adde99-01db-4dee-a59d-9434cbb88495
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 763293399
Hyphenated Format 76329-3399

Supplemental Identifiers

RxCUI
1862220
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 ANDA088636 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 5 SYRINGE in 1 PACKAGE (76329-3399-5) / 10 mL in 1 SYRINGE
source: ndc

Packages (1)

76329-3399-5 5 SYRINGE in 1 PACKAGE (76329-3399-5) / 10 mL in 1 SYRINGE

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": "f3adde99-01db-4dee-a59d-9434cbb88495", "openfda": {"unii": ["SI4064O0LX"], "rxcui": ["1862220"], "spl_set_id": ["d7cb1594-61cf-41c4-9007-1ee28aa69c50"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 SYRINGE in 1 PACKAGE (76329-3399-5)  / 10 mL in 1 SYRINGE", "package_ndc": "76329-3399-5", "marketing_start_date": "20161221"}], "brand_name": "Procainamide Hydrochloride", "product_id": "76329-3399_f3adde99-01db-4dee-a59d-9434cbb88495", "dosage_form": "INJECTION", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "76329-3399", "generic_name": "Procainamide Hydrochloride", "labeler_name": "International Medication Systems, Limited", "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"}