FDA.reportPublic FDA data

PARSABIV

Product NDC
55513-740
11-digit product format
555130740
Labeler code
55513
Product ID
55513-740_52286976-a97a-4b77-b678-f40ab5aa7133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
etelcalcetide
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amgen, Inc
Application
NDA208325
Marketing category
NDA
Marketing start
2017-04-03
Substance
ETELCALCETIDE HYDROCHLORIDE
Active strength
2.5 mg/.5mL
Pharmacologic classes
Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETELCALCETIDE HYDROCHLORIDE2.5 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii72PT5993DU
Rxcui1876127, 1876132, 1876135, 1876136, 1876137, 1876138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f16c46d-505e-4d40-8b28-136c0bf8147dProduct name120170501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-740-01PARSABIV0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.515
55513-740-10PARSABIV10 in 1 CARTONINJECTION, SOLUTION1015
55513-740-20PARSABIV10 in 1 CARTONINJECTION, SOLUTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-740-01ML - Milliliter55513-7405b26250d-6cf1-4ae9-9007-e19ac4c9ef7c12017-11-06
55513-740-10ML - Milliliter55513-74056601ef6-5627-4caf-9b0a-f3f7fbe29edc12017-11-06
55513-740-20ML - Milliliter55513-74038bbdf92-0f20-43b2-aca1-f5a79eb439d512026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-740PARSABIV (ETELCALCETIDE) INJECTION, SOLUTION [AMGEN INC]13Current NDC, Legacy NDC, 3 package rows20220626_cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1876127etelcalcetide 10 MG in 2 ML InjectionPSNcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876137etelcalcetide 2.5 MG in 0.5 ML InjectionPSNcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876135etelcalcetide 5 MG in 1 ML InjectionPSNcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876132Parsabiv 10 MG in 2 ML InjectionPSNcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876138Parsabiv 2.5 MG in 0.5 ML InjectionPSNcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876136Parsabiv 5 MG in 1 ML InjectionPSNcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
18761380.5 ML etelcalcetide 5 MG/ML Injection [Parsabiv]SBDcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
18761361 ML etelcalcetide 5 MG/ML Injection [Parsabiv]SBDcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
18761322 ML etelcalcetide 5 MG/ML Injection [Parsabiv]SBDcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
18761370.5 ML etelcalcetide 5 MG/ML InjectionSCDcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
18761351 ML etelcalcetide 5 MG/ML InjectionSCDcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
18761272 ML etelcalcetide 5 MG/ML InjectionSCDcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876127etelcalcetide 10 MG per 2 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876137etelcalcetide 2.5 MG per 0.5 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876135etelcalcetide 5 MG per 1 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876137etelcalcetide 5 MG/ML per 0.5 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876127etelcalcetide 5 MG/ML per 2 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876132Parsabiv 10 MG per 2 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876138Parsabiv 2.5 MG per 0.5 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876136Parsabiv 5 MG per 1 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876138Parsabiv 5 MG/ML per 0.5 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876136Parsabiv 5 MG/ML per 1 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15
1876132Parsabiv 5 MG/ML per 2 ML InjectionSYcd270093-c6a8-4596-a4ab-e6aa0a2c8a0c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55513-740-01555130740010.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical
55513-740-105551307401010 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) 2017-04-030000-00-00NoNoCurrent
55513-740-205551307402010 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-20) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01) 2025-08-01NoNoCurrent