Paricalcitol

Product NDC
65162-822
11-digit product format
651620822
Labeler code
65162
Product ID
65162-822_35e96bd0-ee09-4adc-a04d-7dcd43466786
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paricalcitol
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA204327
Marketing category
ANDA
Marketing start
2016-01-15
Substance
PARICALCITOL
Active strength
1 ug/1
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
PARICALCITOL1 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6702D36OG5
Rxcui577315, 577317, 577324

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
65162-822-03Paricalcitol30 in 1 BOTTLECAPSULE3013
65162-822-09Paricalcitol90 in 1 BOTTLECAPSULE9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-822PARICALCITOL CAPSULE [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 2 package rows20241031_cd937aab-6ed2-44ef-b91e-82738997ed10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577315paricalcitol 1 MCG Oral CapsulePSNcd937aab-6ed2-44ef-b91e-82738997ed1013
577317paricalcitol 2 MCG Oral CapsulePSNcd937aab-6ed2-44ef-b91e-82738997ed1013
577324paricalcitol 4 MCG Oral CapsulePSNcd937aab-6ed2-44ef-b91e-82738997ed1013
577315paricalcitol 0.001 MG Oral CapsuleSCDcd937aab-6ed2-44ef-b91e-82738997ed1013
577317paricalcitol 0.002 MG Oral CapsuleSCDcd937aab-6ed2-44ef-b91e-82738997ed1013
577324paricalcitol 0.004 MG Oral CapsuleSCDcd937aab-6ed2-44ef-b91e-82738997ed1013
577315paricalcitol 1 MCG Oral CapsuleSYcd937aab-6ed2-44ef-b91e-82738997ed1013
577317paricalcitol 2 MCG Oral CapsuleSYcd937aab-6ed2-44ef-b91e-82738997ed1013
577324paricalcitol 4 MCG Oral CapsuleSYcd937aab-6ed2-44ef-b91e-82738997ed1013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-822-036516208220330 CAPSULE in 1 BOTTLE (65162-822-03) 30 capsule2016-01-150000-00-00NoNoCurrent
65162-822-096516208220990 CAPSULE in 1 BOTTLE (65162-822-09) 90 capsule2016-01-150000-00-00NoNoCurrent