FDA.reportPublic FDA data

Paricalcitol

Product NDC
16729-310
11-digit product format
167290310
Labeler code
16729
Product ID
16729-310_1e7e9c4e-79dd-a776-e063-6394a90a43a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paricalcitol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
NDA207174
Marketing category
NDA
Marketing start
2016-03-24
Substance
PARICALCITOL
Active strength
2 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
PARICALCITOL2 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6702D36OG5
Rxcui200321, 1736919, 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
16729-310-08Paricalcitol1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION15
16729-310-08Paricalcitol25 in 1 CARTONINJECTION, SOLUTION255
16729-310-63Paricalcitol1 in 1 CARTONINJECTION, SOLUTION15
16729-310-63Paricalcitol1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-310-08ML - Milliliter16729-31078e5dbe2-0f5a-4475-a3a7-36867c5ce23e12016-04-04
16729-310-63ML - Milliliter16729-310a6058af3-ef0f-4479-a702-249cc7ae290912016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-310PARICALCITOL INJECTION, SOLUTION [ACCORD HEALTHCARE, INC.]5Current NDC, Legacy NDC, 4 package rows20240806_2b7c7587-2042-0d9c-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736931paricalcitol 2 MCG in 1 ML InjectionPSN2b7c7587-2042-0d9c-e054-00144ff88e885
1736919paricalcitol 5 MCG in 1 ML InjectionPSN2b7c7587-2042-0d9c-e054-00144ff88e885
200321paricalcitol 5 MCG/ML Injectable SolutionPSN2b7c7587-2042-0d9c-e054-00144ff88e885
17369311 ML paricalcitol 0.002 MG/ML InjectionSCD2b7c7587-2042-0d9c-e054-00144ff88e885
17369191 ML paricalcitol 0.005 MG/ML InjectionSCD2b7c7587-2042-0d9c-e054-00144ff88e885
200321paricalcitol 0.005 MG/ML Injectable SolutionSCD2b7c7587-2042-0d9c-e054-00144ff88e885
200321paricalcitol 10 MCG per 2 ML Injectable SolutionSY2b7c7587-2042-0d9c-e054-00144ff88e885
1736931paricalcitol 2 MCG per 1 ML InjectionSY2b7c7587-2042-0d9c-e054-00144ff88e885
200321paricalcitol 5 MCG per 1 ML Injectable SolutionSY2b7c7587-2042-0d9c-e054-00144ff88e885
1736919paricalcitol 5 MCG per 1 ML InjectionSY2b7c7587-2042-0d9c-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-310-081672903100825 VIAL, SINGLE-DOSE in 1 CARTON (16729-310-08) / 1 mL in 1 VIAL, SINGLE-DOSE2016-03-240000-00-00NoNoCurrent
16729-310-63167290310631 VIAL, SINGLE-DOSE in 1 CARTON (16729-310-63) / 1 mL in 1 VIAL, SINGLE-DOSE2016-03-240000-00-00NoNoCurrent