FDA.reportPublic FDA data

Procainamide Hydrochloride

Product NDC
0409-1902
11-digit product format
004091902
Labeler code
0409
Product ID
0409-1902_5c75003d-8b7f-4e26-b76e-11a749a53ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCAINAMIDE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA089069
Marketing category
ANDA
Marketing start
2006-03-08
Substance
PROCAINAMIDE HYDROCHLORIDE
Active strength
100 mg/mL
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Procainamide Hydrochloride
Listing expiration
2027-12-31

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
0409-1902-01Procainamide Hydrochloride25 in 1 CASEINJECTION, SOLUTION2525
0409-1902-11Procainamide Hydrochloride10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1025
0409-1902-11Procainamide Hydrochloride1 in 1 CARTONINJECTION, SOLUTION125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1902-01ML - Milliliter0409-1902b5bb6da4-8bb6-48a9-8ae2-097ed82e95ac12012-07-24
0409-1902-11ML - Milliliter0409-1902ec8f06c8-394b-4141-ae72-4183c976132c12020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCAINAMIDE HYDROCHLORIDEACTIVE INGREDIENTSI4064O0LXPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
PROCAINAMIDEACTIVE MOIETYL39WTC366DPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RPROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1902PROCAINAMIDE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]24Current NDC, Legacy NDC, 3 package rows20230629_17e47845-daad-434c-a784-6d3875b0d704.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857886procainamide HCl 100 MG/ML Injectable SolutionPSN17e47845-daad-434c-a784-6d3875b0d70425
857886procainamide hydrochloride 100 MG/ML Injectable SolutionSCD17e47845-daad-434c-a784-6d3875b0d70425
857886procainamide HCl 100 MG/ML Injectable SolutionPSN8192d79d-da2b-2532-e053-2991aa0ae8ad6
857886procainamide hydrochloride 100 MG/ML Injectable SolutionSCD8192d79d-da2b-2532-e053-2991aa0ae8ad6
857886procainamide HCl 100 MG/ML Injectable SolutionPSN0aac32fa-37b7-5520-e063-6394a90a1fe41
857886procainamide hydrochloride 100 MG/ML Injectable SolutionSCD0aac32fa-37b7-5520-e063-6394a90a1fe41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1902-010040919020125 CARTON in 1 CASE (0409-1902-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1902-11) / 10 mL in 1 VIAL, MULTI-DOSE25 carton2006-03-080000-00-00NoNoCurrent
0409-1902-110040919021110 mL in 1 VIAL, MULTI-DOSE10 mlHistorical