PROCAINAMIDE HCI

Product NDC
51662-1334
11-digit product format
516621334
Labeler code
51662
Product ID
51662-1334_11c18bb0-a2ec-54f0-e063-6294a90a57c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCAINAMIDE HCI
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA089069
Marketing category
ANDA
Marketing start
2019-02-10
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 HCI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCAINAMIDE HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSI4064O0LX
Rxcui857886

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1334-1PROCAINAMIDE HCI10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION106
51662-1334-1PROCAINAMIDE HCI1 in 1 CARTONINJECTION, SOLUTION16
51662-1334-2PROCAINAMIDE HCI10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION106
51662-1334-2PROCAINAMIDE HCI1 in 1 POUCHINJECTION, SOLUTION16
51662-1334-3PROCAINAMIDE HCI25 in 1 BOXINJECTION, SOLUTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1334PROCAINAMIDE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]6Current NDC, Legacy NDC, 5 package rows20240220_8192d79d-da2b-2532-e053-2991aa0ae8ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857886procainamide HCl 100 MG/ML Injectable SolutionPSN8192d79d-da2b-2532-e053-2991aa0ae8ad6
857886procainamide hydrochloride 100 MG/ML Injectable SolutionSCD8192d79d-da2b-2532-e053-2991aa0ae8ad6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1334-1516621334011 VIAL, MULTI-DOSE in 1 CARTON (51662-1334-1) / 10 mL in 1 VIAL, MULTI-DOSE2019-02-100000-00-00NoNoCurrent
51662-1334-25166213340210 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
51662-1334-35166213340325 POUCH in 1 BOX (51662-1334-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1334-2) / 10 mL in 1 VIAL, MULTI-DOSE25 pouch2022-03-150000-00-00NoNoCurrent