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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202539-001PARICALCITOLPARICALCITOL1MCGCAPSULE / ORALAB2014-03-27
A202539-002PARICALCITOLPARICALCITOL2MCGCAPSULE / ORALAB2014-03-27
A202539-003PARICALCITOLPARICALCITOL4MCGCAPSULE / ORALAB2014-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202539-001AB
A202539-002AB
A202539-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-27a50c72e98297…
2026-08-01 22:54:322026-06A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-27a50c72e98297…
2026-08-01 22:54:322026-06A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202539-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202539-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202539-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParicalcitolPARICALCITOLBryant Ranch Prepack664253fb-d99d-4af6-971b-95c0087406d92026-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202539
application number: ANDA202539
ParicalcitolPARICALCITOLBryant Ranch Prepack22a0d467-9881-458f-8b1c-1186feb96ee42024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202539
application number: ANDA202539
ParicalcitolPARICALCITOLBryant Ranch Prepack52ca3d88-e85d-44a9-8aa7-eb25a8a73f6f2024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202539
application number: ANDA202539
ParicalcitolPARICALCITOLBryant Ranch Prepackd62d977a-bbfc-454a-a4a9-017a9f5255742024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202539
application number: ANDA202539
ParicalcitolPARICALCITOLBionpharma Inc.755476e5-62a2-4f01-92a3-307e192ad42c2023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202539
application number: ANDA202539
ndc (product): 69452-146

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6702D36OG5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577315Internal RxNorm lookup
577317Internal RxNorm lookup
577324Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
755476e5-62a2-4f01-92a3-307e192ad42cAvailable on FDA.report

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