Pentetate calcium trisodium

Product NDC
70651-001
11-digit product format
706510001
Labeler code
70651
Product ID
70651-001_1b3410c5-6dba-401e-8a6e-4b483e65dc48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pentetate calcium trisodium
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS; RESPIRATORY (INHALATION)
Labeler
hameln pharma gmbh
Application
NDA021749
Marketing category
NDA
Marketing start
2004-08-11
Marketing end
2026-05-31
Substance
PENTETATE CALCIUM TRISODIUM
Active strength
1000 mg/5mL
Pharmacologic classes
Lead Chelating Activity [MoA], Lead Chelator [EPC]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70651-001-03Pentetate calcium trisodium5 mL in 1 AMPULEINJECTION, SOLUTION, CONCENTRATE54
70651-001-03Pentetate calcium trisodium10 in 1 PACKAGEINJECTION, SOLUTION, CONCENTRATE104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70651-001-03ML - Milliliter70651-00162587112-d99e-4b8f-a4b4-894e4890dbfd12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70651-001PENTETATE CALCIUM TRISODIUM INJECTION, SOLUTION, CONCENTRATE [HAMELN PHARMA GMBH]4Current NDC, Legacy NDC, 2 package rows20210131_bc563e90-10e5-475d-aa84-b0e3d582ae95.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70651-001-037065100010310 AMPULE in 1 PACKAGE (70651-001-03) / 5 mL in 1 AMPULE10 ampule2004-08-112026-05-31NoNoCurrent