FDA.reportPublic FDA data

Paricalcitol

Product NDC
69452-146
11-digit product format
694520146
Labeler code
69452
Product ID
69452-146_0d856fce-7c7d-18e7-e063-6394a90ac945
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paricalcitol
Dosage form
CAPSULE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA202539
Marketing category
ANDA
Marketing start
2016-08-16
Substance
PARICALCITOL
Active strength
2 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
PARICALCITOL2 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
69452-146-13Paricalcitol30 in 1 BOTTLE, PLASTICCAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-146-13EA - Each69452-146f4c12a48-4d93-41f2-ad4a-4222985b23da12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-146PARICALCITOL CAPSULE [BIONPHARMA INC.]5Current NDC, Legacy NDC, 1 package rows20231228_755476e5-62a2-4f01-92a3-307e192ad42c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577317paricalcitol 2 MCG Oral CapsulePSN52ca3d88-e85d-44a9-8aa7-eb25a8a73f6f106
577317paricalcitol 0.002 MG Oral CapsuleSCD52ca3d88-e85d-44a9-8aa7-eb25a8a73f6f106
577317paricalcitol 2 MCG Oral CapsuleSY52ca3d88-e85d-44a9-8aa7-eb25a8a73f6f106
577317paricalcitol 2 MCG Oral CapsulePSNd62d977a-bbfc-454a-a4a9-017a9f525574101
577317paricalcitol 0.002 MG Oral CapsuleSCDd62d977a-bbfc-454a-a4a9-017a9f525574101
577317paricalcitol 2 MCG Oral CapsuleSYd62d977a-bbfc-454a-a4a9-017a9f525574101
577315paricalcitol 1 MCG Oral CapsulePSN755476e5-62a2-4f01-92a3-307e192ad42c5
577317paricalcitol 2 MCG Oral CapsulePSN755476e5-62a2-4f01-92a3-307e192ad42c5
577324paricalcitol 4 MCG Oral CapsulePSN755476e5-62a2-4f01-92a3-307e192ad42c5
577315paricalcitol 0.001 MG Oral CapsuleSCD755476e5-62a2-4f01-92a3-307e192ad42c5
577317paricalcitol 0.002 MG Oral CapsuleSCD755476e5-62a2-4f01-92a3-307e192ad42c5
577324paricalcitol 0.004 MG Oral CapsuleSCD755476e5-62a2-4f01-92a3-307e192ad42c5
577315paricalcitol 1 MCG Oral CapsuleSY755476e5-62a2-4f01-92a3-307e192ad42c5
577317paricalcitol 2 MCG Oral CapsuleSY755476e5-62a2-4f01-92a3-307e192ad42c5
577324paricalcitol 4 MCG Oral CapsuleSY755476e5-62a2-4f01-92a3-307e192ad42c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-146-136945201461330 CAPSULE in 1 BOTTLE, PLASTIC (69452-146-13) 30 capsule2016-08-160000-00-00NoNoCurrent