PROCAINAMIDE HCI

Product NDC
51662-1392
11-digit product format
516621392
Labeler code
51662
Product ID
51662-1392_ba9f0d91-3f55-467f-e053-2995a90ab20b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCAINAMIDE HCI
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA089070
Marketing category
ANDA
Marketing start
2019-10-16
Marketing end
0000-00-00
Substance
PROCAINAMIDE HYDROCHLORIDE
Active strength
500 mg/mL
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
67853295-be49-b731-d597-94f59291a90cProduct name320250311

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1392-1PROCAINAMIDE HCI2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION25
51662-1392-2PROCAINAMIDE HCI1 mL in 1 POUCHINJECTION, SOLUTION15
51662-1392-3PROCAINAMIDE HCI25 in 1 CASEINJECTION, SOLUTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1392PROCAINAMIDE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Legacy NDC, 3 package rows20230425_9508d1a2-da9a-5480-e053-2a95a90a73c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857962procainamide HCl 500 MG/ML Injectable SolutionPSN9508d1a2-da9a-5480-e053-2a95a90a73c75
857962procainamide hydrochloride 500 MG/ML Injectable SolutionSCD9508d1a2-da9a-5480-e053-2a95a90a73c75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1392-1516621392012 mL in 1 VIAL, MULTI-DOSE (51662-1392-1) 2 ml2019-10-160000-00-00NoNoCurrent
51662-1392-2516621392021 mL in 1 POUCH1 mlHistorical
51662-1392-35166213920325 POUCH in 1 CASE (51662-1392-3) > 1 mL in 1 POUCH (51662-1392-2) 25 pouch2020-09-260000-00-00NoNoCurrent