FDA.reportPublic FDA data

Procainamide Hydrochloride

Product NDC
70518-4208
11-digit product format
705184208
Labeler code
70518
Product ID
70518-4208_3ff5badd-ddd6-8f29-e063-6294a90aa9f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Procainamide Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA088636
Marketing category
ANDA
Marketing start
2024-10-10
Substance
PROCAINAMIDE HYDROCHLORIDE
Active strength
100 mg/mL
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Procainamide Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCAINAMIDE HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSI4064O0LX
Rxcui1862220

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
67853295-be49-b731-d597-94f59291a90cProduct name320250311
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4208-0Procainamide Hydrochloride5 in 1 PACKAGEINJECTION52
70518-4208-1Procainamide Hydrochloride10 mL in 1 SYRINGEINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-4208-1ML - Milliliter70518-42081d6b30b2-5c22-47ea-b6fa-2393d2dce64712026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4208PROCAINAMIDE HYDROCHLORIDE INJECTION [REMEDYREPACK INC.]1Current NDC, 2 package rows20241013_1ec3b767-66bb-4634-877e-71f70d501da0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1862220procainamide HCl 1000 MG in 10 ML Prefilled SyringePSN1ec3b767-66bb-4634-877e-71f70d501da02
186222010 ML procainamide hydrochloride 100 MG/ML Prefilled SyringeSCD1ec3b767-66bb-4634-877e-71f70d501da02
1862220procainamide HCl 1000 MG per 10 ML Prefilled SyringeSY1ec3b767-66bb-4634-877e-71f70d501da02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4208-0705184208005 SYRINGE in 1 PACKAGE (70518-4208-0) / 10 mL in 1 SYRINGE (70518-4208-1) 5 syringe2024-10-10NoNoHistorical
70518-4208-17051842080110 mL in 1 SYRINGE10 mlHistorical