FDA.reportPublic FDA data

Zemplar

Product NDC
0074-1658
11-digit product format
000741658
Labeler code
0074
Product ID
0074-1658_e3e59fde-f50f-49a4-8932-c1f53f579009
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paricalcitol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
AbbVie Inc.
Application
NDA020819
Marketing category
NDA
Marketing start
1998-04-17
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
Zemplar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PARICALCITOL5 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6702D36OG5
Rxcui200321, 213298, 352076, 1736919, 1736921, 1736931

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
0074-1658-01Zemplar25 in 1 TRAYINJECTION, SOLUTION251482
0074-1658-01Zemplar1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION11482
0074-1658-05Zemplar25 in 1 TRAYINJECTION, SOLUTION251482
0074-1658-05Zemplar2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION21482

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-1658-01ML - Milliliter0074-165863b9ba9c-0d57-4ddc-b7a0-e9b00c1fcbf312012-07-24
0074-1658-05ML - Milliliter0074-1658c5ee97f8-40a4-4568-a2c7-7b646bca963612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PARICALCITOLACTIVE INGREDIENT6702D36OG5ZEMPLAR (PARICALCITOL) INJECTION, SOLUTION [ABBVIE INC.]1439
PARICALCITOLACTIVE MOIETY6702D36OG5ZEMPLAR (PARICALCITOL) INJECTION, SOLUTION [ABBVIE INC.]1439
ALCOHOLINACTIVE INGREDIENT3K9958V90MZEMPLAR (PARICALCITOL) INJECTION, SOLUTION [ABBVIE INC.]1439
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZEMPLAR (PARICALCITOL) INJECTION, SOLUTION [ABBVIE INC.]1439
WATERINACTIVE INGREDIENT059QF0KO0RZEMPLAR (PARICALCITOL) INJECTION, SOLUTION [ABBVIE INC.]1439

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-1658ZEMPLAR (PARICALCITOL) INJECTION, SOLUTION [ABBVIE INC.]1481Current NDC, Legacy NDC, 4 package rows20240913_7259652f-81bc-4ad1-bba5-d01f9fac1b80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736931paricalcitol 2 MCG in 1 ML InjectionPSN7259652f-81bc-4ad1-bba5-d01f9fac1b801482
1736919paricalcitol 5 MCG in 1 ML InjectionPSN7259652f-81bc-4ad1-bba5-d01f9fac1b801482
200321paricalcitol 5 MCG/ML Injectable SolutionPSN7259652f-81bc-4ad1-bba5-d01f9fac1b801482
352076Zemplar 2 MCG in 1 ML InjectionPSN7259652f-81bc-4ad1-bba5-d01f9fac1b801482
1736921Zemplar 5 MCG in 1 ML InjectionPSN7259652f-81bc-4ad1-bba5-d01f9fac1b801482
213298Zemplar 5 MCG/ML Injectable SolutionPSN7259652f-81bc-4ad1-bba5-d01f9fac1b801482
3520761 ML paricalcitol 0.002 MG/ML Injection [Zemplar]SBD7259652f-81bc-4ad1-bba5-d01f9fac1b801482
17369211 ML paricalcitol 0.005 MG/ML Injection [Zemplar]SBD7259652f-81bc-4ad1-bba5-d01f9fac1b801482
213298paricalcitol 0.005 MG/ML Injectable Solution [Zemplar]SBD7259652f-81bc-4ad1-bba5-d01f9fac1b801482
17369311 ML paricalcitol 0.002 MG/ML InjectionSCD7259652f-81bc-4ad1-bba5-d01f9fac1b801482
17369191 ML paricalcitol 0.005 MG/ML InjectionSCD7259652f-81bc-4ad1-bba5-d01f9fac1b801482
200321paricalcitol 0.005 MG/ML Injectable SolutionSCD7259652f-81bc-4ad1-bba5-d01f9fac1b801482
200321paricalcitol 10 MCG per 2 ML Injectable SolutionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482
1736931paricalcitol 2 MCG per 1 ML InjectionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482
200321paricalcitol 5 MCG per 1 ML Injectable SolutionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482
1736919paricalcitol 5 MCG per 1 ML InjectionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482
213298Zemplar 0.005 MG/ML Injectable SolutionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482
213298Zemplar 10 MCG per 2 ML Injectable SolutionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482
352076Zemplar 2 MCG per 1 ML InjectionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482
213298Zemplar 5 MCG per 1 ML Injectable SolutionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482
1736921Zemplar 5 MCG per 1 ML InjectionSY7259652f-81bc-4ad1-bba5-d01f9fac1b801482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0074-1658-010007416580125 VIAL, SINGLE-DOSE in 1 TRAY (0074-1658-01) / 1 mL in 1 VIAL, SINGLE-DOSE1998-04-170000-00-00NoNoCurrent
0074-1658-050007416580525 VIAL, MULTI-DOSE in 1 TRAY (0074-1658-05) / 2 mL in 1 VIAL, MULTI-DOSE1998-04-170000-00-00NoNoCurrent