Paricalcitol

Product NDC
72162-1915
11-digit product format
721621915
Labeler code
72162
Product ID
72162-1915_54db0128-fe43-4d4d-8ea9-494b03310b6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paricalcitol
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202539
Marketing category
ANDA
Marketing start
2016-08-16
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202539-002PARICALCITOL2MCGCAPSULE / ORALAB2014-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202539-003PARICALCITOL4MCGCAPSULE / ORALAB2014-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202539-001PARICALCITOL1MCGCAPSULE / ORALAB2014-03-271e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202539-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202539-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202539-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202539-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202539-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202539-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202539-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202539-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202539-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202539-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202539-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202539-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202539-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202539-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202539-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202539-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202539-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202539-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202539-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202539-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202539-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202539-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202539-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202539-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202539-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202539-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202539-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202539-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202539-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202539-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202539-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202539-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202539-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202539-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202539-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202539-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202539-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202539-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202539-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202539-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Paricalcitol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PARICALCITOL1 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
664253fb-d99d-4af6-971b-95c0087406d9Available 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
72162-1915-3Paricalcitol30 in 1 BOTTLE, PLASTICCAPSULE30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1915-3EA - Each72162-19158c4e4278-a9c2-408b-952b-51a53c2569e512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1915PARICALCITOL CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240417_664253fb-d99d-4af6-971b-95c0087406d9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (product): 72162-1915
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577315paricalcitol 1 MCG Oral CapsulePSN664253fb-d99d-4af6-971b-95c0087406d9102
577315paricalcitol 0.001 MG Oral CapsuleSCD664253fb-d99d-4af6-971b-95c0087406d9102
577315paricalcitol 1 MCG Oral CapsuleSY664253fb-d99d-4af6-971b-95c0087406d9102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1915-37216219150330 CAPSULE in 1 BOTTLE, PLASTIC (72162-1915-3) 30 capsule2024-04-03NoNoCurrent