procainamide hydrochloride

Generic: procainamide hydrochloride

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

procainamide hydrochloride 100 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-155
Product ID 65145-155_b7308804-0dc7-4740-8041-1dd391f950a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218674
Listing Expiration 2026-12-31
Marketing Start 2025-02-17

Pharmacologic Class

Classes
antiarrhythmic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145155
Hyphenated Format 65145-155

Supplemental Identifiers

RxCUI
857886 857962
UPC
0365145156013 0365145155016 0365145156105 0365145155108
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 ANDA218674 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (65145-155-10) / 10 mL in 1 VIAL, MULTI-DOSE (65145-155-01)
source: ndc

Packages (1)

65145-155-10 10 VIAL, MULTI-DOSE in 1 CARTON (65145-155-10) / 10 mL in 1 VIAL, MULTI-DOSE (65145-155-01)

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": "b7308804-0dc7-4740-8041-1dd391f950a4", "openfda": {"upc": ["0365145156013", "0365145155016", "0365145156105", "0365145155108"], "unii": ["SI4064O0LX"], "rxcui": ["857886", "857962"], "spl_set_id": ["fcaa5e9a-3c8a-4796-aa87-626268b6cf60"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (65145-155-10)  / 10 mL in 1 VIAL, MULTI-DOSE (65145-155-01)", "package_ndc": "65145-155-10", "marketing_start_date": "20250217"}], "brand_name": "Procainamide Hydrochloride", "product_id": "65145-155_b7308804-0dc7-4740-8041-1dd391f950a4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antiarrhythmic [EPC]"], "product_ndc": "65145-155", "generic_name": "Procainamide Hydrochloride", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Procainamide Hydrochloride", "active_ingredients": [{"name": "PROCAINAMIDE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "ANDA218674", "marketing_category": "ANDA", "marketing_start_date": "20250217", "listing_expiration_date": "20261231"}