Paricalcitol

Product NDC
0143-9596
11-digit product format
001439596
Labeler code
0143
Product ID
0143-9596_5830f342-11e2-4859-98c8-fdcfd89d606d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paricalcitol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
West-Ward Pharmaceuticals Corp
Application
NDA205917
Marketing category
NDA
Marketing start
2014-11-18
Substance
PARICALCITOL
Active strength
5 ug/mL
Pharmacologic classes
Cholecalciferol [CS], Vitamin D3 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 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
N205917-001PARICALCITOLPARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-11-18
N205917-002PARICALCITOLPARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-18
N205917-003PARICALCITOLPARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-18

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 06:07:402026-07N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-11-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205917-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205917-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUSAP2014-11-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205917-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUSAP2014-11-181e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205917-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205917-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205917-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205917-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205917-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205917-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205917-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205917-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205917-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205917-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205917-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205917-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205917-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205917-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205917-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205917-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205917-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205917-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205917-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N205917-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N205917-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205917-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205917-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205917-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205917-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205917-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205917-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205917-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205917-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205917-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205917-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205917-002AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205917-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205917-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205917-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205917-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205917-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205917-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205917-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205917-001AP14b0b4de00fa7…

Additional Listing Data#

Finished product
Yes
Brand name base
Paricalcitol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PARICALCITOL5 ug/mL

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
200321Internal RxNorm lookup
1736919Internal RxNorm lookup
1736931Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4db985c4-3ba2-4967-898b-35af77f150deAvailable 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
0143-9596-01Paricalcitol2 mL in 1 VIAL, MULTI-DOSEINJECTION22
0143-9596-25Paricalcitol25 in 1 CARTONINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9596-01ML - Milliliter0143-959668114772-1a03-41f9-8fb4-76d616eaee7712015-09-10
0143-9596-25ML - Milliliter0143-9596e48e0e14-87df-4396-9dfc-8bfe1ecaa6f312015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PARICALCITOLACTIVE INGREDIENT6702D36OG5PARICALCITOL INJECTION [WEST-WARD PHARMACEUTICAL CORP]1
PARICALCITOLACTIVE MOIETY6702D36OG5PARICALCITOL INJECTION [WEST-WARD PHARMACEUTICAL CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPARICALCITOL INJECTION [WEST-WARD PHARMACEUTICAL CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RPARICALCITOL INJECTION [WEST-WARD PHARMACEUTICAL CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RPARICALCITOL INJECTION [WEST-WARD PHARMACEUTICAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9596PARICALCITOL INJECTION [WEST-WARD PHARMACEUTICALS CORP]2Current NDC, Legacy NDC, 2 package rows20181213_4db985c4-3ba2-4967-898b-35af77f150de.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParicalcitolPARICALCITOLWest-Ward Pharmaceuticals Corp4db985c4-3ba2-4967-898b-35af77f150de2018-12-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 205917
application number: NDA205917
ndc (product): 0143-9596

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1736931paricalcitol 2 MCG in 1 ML InjectionPSN4db985c4-3ba2-4967-898b-35af77f150de2
1736919paricalcitol 5 MCG in 1 ML InjectionPSN4db985c4-3ba2-4967-898b-35af77f150de2
200321paricalcitol 5 MCG/ML Injectable SolutionPSN4db985c4-3ba2-4967-898b-35af77f150de2
17369311 ML paricalcitol 0.002 MG/ML InjectionSCD4db985c4-3ba2-4967-898b-35af77f150de2
17369191 ML paricalcitol 0.005 MG/ML InjectionSCD4db985c4-3ba2-4967-898b-35af77f150de2
200321paricalcitol 0.005 MG/ML Injectable SolutionSCD4db985c4-3ba2-4967-898b-35af77f150de2
200321paricalcitol 10 MCG per 2 ML Injectable SolutionSY4db985c4-3ba2-4967-898b-35af77f150de2
1736931paricalcitol 2 MCG per 1 ML InjectionSY4db985c4-3ba2-4967-898b-35af77f150de2
200321paricalcitol 5 MCG per 1 ML Injectable SolutionSY4db985c4-3ba2-4967-898b-35af77f150de2
1736919paricalcitol 5 MCG per 1 ML InjectionSY4db985c4-3ba2-4967-898b-35af77f150de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9596-01001439596012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
0143-9596-250014395962525 VIAL, MULTI-DOSE in 1 CARTON (0143-9596-25) / 2 mL in 1 VIAL, MULTI-DOSE (0143-9596-01) 2014-11-180000-00-00NoNoCurrent