PARICALCITOL

Product NDC
55150-213
11-digit product format
551500213
Labeler code
55150
Product ID
55150-213_9ecb6fd2-c8d0-4092-b53c-b63e8a835fba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PARICALCITOL
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA205982
Marketing category
ANDA
Marketing start
2018-10-09
Substance
PARICALCITOL
Active strength
5 ug/mL
Pharmacologic classes
Ergocalciferols [CS], Vitamin D Analog [EPC], Vitamin D2 Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PARICALCITOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PARICALCITOL5 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6702D36OG5
Rxcui200321, 1736919, 1736931, 1807896

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d92c0b9e-f894-bf80-45eb-73308b7f7f62Product name820190124
3c05259b-d0ee-c435-cb1a-db5d01cf3e37Product name520161206
35d6155d-80a2-4122-bd18-18decc40ac12Product name220150902

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-213-01PARICALCITOL25 in 1 CARTONINJECTION258
55150-213-01PARICALCITOL1 mL in 1 VIAL, SINGLE-DOSEINJECTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-213-01ML - Milliliter55150-213b45f4baf-4859-4e42-a883-2ac48b655a0412019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-213PARICALCITOL INJECTION [EUGIA US LLC]7Current NDC, Legacy NDC, 2 package rows20231125_6937c596-9ca4-480e-9090-b9d8a3c271c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807896paricalcitol 10 MCG in 2 ML InjectionPSN6937c596-9ca4-480e-9090-b9d8a3c271c88
1736931paricalcitol 2 MCG in 1 ML InjectionPSN6937c596-9ca4-480e-9090-b9d8a3c271c88
1736919paricalcitol 5 MCG in 1 ML InjectionPSN6937c596-9ca4-480e-9090-b9d8a3c271c88
200321paricalcitol 5 MCG/ML Injectable SolutionPSN6937c596-9ca4-480e-9090-b9d8a3c271c88
17369311 ML paricalcitol 0.002 MG/ML InjectionSCD6937c596-9ca4-480e-9090-b9d8a3c271c88
17369191 ML paricalcitol 0.005 MG/ML InjectionSCD6937c596-9ca4-480e-9090-b9d8a3c271c88
18078962 ML paricalcitol 0.005 MG/ML InjectionSCD6937c596-9ca4-480e-9090-b9d8a3c271c88
200321paricalcitol 0.005 MG/ML Injectable SolutionSCD6937c596-9ca4-480e-9090-b9d8a3c271c88
200321paricalcitol 10 MCG per 2 ML Injectable SolutionSY6937c596-9ca4-480e-9090-b9d8a3c271c88
1807896paricalcitol 10 MCG per 2 ML InjectionSY6937c596-9ca4-480e-9090-b9d8a3c271c88
1736931paricalcitol 2 MCG per 1 ML InjectionSY6937c596-9ca4-480e-9090-b9d8a3c271c88
200321paricalcitol 5 MCG per 1 ML Injectable SolutionSY6937c596-9ca4-480e-9090-b9d8a3c271c88
1736919paricalcitol 5 MCG per 1 ML InjectionSY6937c596-9ca4-480e-9090-b9d8a3c271c88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-213-015515002130125 VIAL, SINGLE-DOSE in 1 CARTON (55150-213-01) / 1 mL in 1 VIAL, SINGLE-DOSE2018-10-090000-00-00NoNoCurrent