Paricalcitol

Product NDC
70121-1036
11-digit product format
701211036
Labeler code
70121
Product ID
70121-1036_26de8aad-c6ec-4bac-ae94-5772a69b79ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paricalcitol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA206699
Marketing category
ANDA
Marketing start
2017-03-09
Substance
PARICALCITOL
Active strength
10 ug/2mL
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
PARICALCITOL10 ug/2mL

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
70121-1036-1Paricalcitol2 mL in 1 VIAL, MULTI-DOSEINJECTION212
70121-1036-5Paricalcitol25 in 1 CARTONINJECTION2512
70121-1036-7Paricalcitol10 in 1 CARTONINJECTION1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1036PARICALCITOL INJECTION [AMNEAL PHARMACEUTICALS LLC]12Current NDC, Legacy NDC, 3 package rows20241224_8e0b016c-4bda-487e-b525-63abfb772761.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807896paricalcitol 10 MCG in 2 ML InjectionPSN8e0b016c-4bda-487e-b525-63abfb77276112
1736931paricalcitol 2 MCG in 1 ML InjectionPSN8e0b016c-4bda-487e-b525-63abfb77276112
1736919paricalcitol 5 MCG in 1 ML InjectionPSN8e0b016c-4bda-487e-b525-63abfb77276112
200321paricalcitol 5 MCG/ML Injectable SolutionPSN8e0b016c-4bda-487e-b525-63abfb77276112
17369311 ML paricalcitol 0.002 MG/ML InjectionSCD8e0b016c-4bda-487e-b525-63abfb77276112
17369191 ML paricalcitol 0.005 MG/ML InjectionSCD8e0b016c-4bda-487e-b525-63abfb77276112
18078962 ML paricalcitol 0.005 MG/ML InjectionSCD8e0b016c-4bda-487e-b525-63abfb77276112
200321paricalcitol 0.005 MG/ML Injectable SolutionSCD8e0b016c-4bda-487e-b525-63abfb77276112
200321paricalcitol 10 MCG per 2 ML Injectable SolutionSY8e0b016c-4bda-487e-b525-63abfb77276112
1807896paricalcitol 10 MCG per 2 ML InjectionSY8e0b016c-4bda-487e-b525-63abfb77276112
1736931paricalcitol 2 MCG per 1 ML InjectionSY8e0b016c-4bda-487e-b525-63abfb77276112
200321paricalcitol 5 MCG per 1 ML Injectable SolutionSY8e0b016c-4bda-487e-b525-63abfb77276112
1736919paricalcitol 5 MCG per 1 ML InjectionSY8e0b016c-4bda-487e-b525-63abfb77276112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1036-1701211036012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
70121-1036-57012110360525 VIAL, MULTI-DOSE in 1 CARTON (70121-1036-5) / 2 mL in 1 VIAL, MULTI-DOSE (70121-1036-1) 2017-03-090000-00-00NoNoCurrent
70121-1036-77012110360710 VIAL, MULTI-DOSE in 1 CARTON (70121-1036-7) / 2 mL in 1 VIAL, MULTI-DOSE (70121-1036-1) 2017-03-090000-00-00NoNoCurrent