FDA.reportPublic FDA data

Procainamide Hydrochloride

Product NDC
25021-323
11-digit product format
250210323
Labeler code
25021
Product ID
25021-323_65bd5a24-3fbb-4264-b26f-5839143936db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Procainamide Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA218135
Marketing category
ANDA
Marketing start
2025-01-15
Substance
PROCAINAMIDE HYDROCHLORIDE
Active strength
500 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 HYDROCHLORIDE500 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSI4064O0LX
Rxcui857886, 857962

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
25021-323-02Procainamide Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101
25021-323-02Procainamide Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-323-02ML - Milliliter25021-3236ac86218-fb81-42c0-8734-ee1e9384f5d112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-323PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20250115_358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857886procainamide HCl 100 MG/ML Injectable SolutionPSN358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a1
857962procainamide HCl 500 MG/ML Injectable SolutionPSN358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a1
857886procainamide hydrochloride 100 MG/ML Injectable SolutionSCD358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a1
857962procainamide hydrochloride 500 MG/ML Injectable SolutionSCD358c956e-8c6c-4bd6-a6bc-194d5b3d6d9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-323-022502103230210 VIAL in 1 CARTON (25021-323-02) / 2 mL in 1 VIAL10 vial2025-01-15NoNoHistorical