Paricalcitol

Product NDC
0409-1008
11-digit product format
004091008
Labeler code
0409
Product ID
0409-1008_1cf0245e-2ec9-4490-afa2-95b52fa79eec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PARICALCITOL
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA201657
Marketing category
NDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
PARICALCITOL
Active strength
5 ug/mL
Pharmacologic classes
Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0409-1008DDiscontinued by firm2026-08-17
excluded packagepackage0409-10080409-1008-01DDiscontinued by firm2026-08-17
excluded packagepackage0409-10080409-1008-02DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-1008-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0409-1008-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-1008-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0409-1008-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-1008-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-1008-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-1008-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-1008-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-1008-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-1008-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-1008-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-1008-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-1008-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-1008-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-1008-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-1008-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-1008-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-1008-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-1008-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0409-1008-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-1008-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0409-1008-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-1008-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0409-1008-02557ba5c1ecfa…9c80585c8c6e…

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
N201657-001PARICALCITOLPARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-21
N201657-002PARICALCITOLPARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21
N201657-003PARICALCITOLPARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21

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 06:07:402026-07N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21caaa826d4ba7…
2026-08-18 06:07:402026-07N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201657-002PARICALCITOL0.005MG/ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201657-003PARICALCITOL0.01MG/2ML (0.005MG/ML)SOLUTION / INTRAVENOUS2014-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201657-001PARICALCITOL0.002MG/ML (0.002MG/ML)SOLUTION / INTRAVENOUS2014-10-211e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05N201657-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N201657-002AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N201657-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201657-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201657-002AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201657-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201657-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N201657-002AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N201657-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201657-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N201657-002AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N201657-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N201657-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N201657-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N201657-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N201657-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N201657-002AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N201657-003AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201657-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N201657-002AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N201657-003AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201657-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201657-002AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201657-003AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N201657-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N201657-002AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N201657-003AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N201657-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N201657-002AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N201657-003AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N201657-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N201657-002AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N201657-003AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N201657-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N201657-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12N201657-003AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N201657-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N201657-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09N201657-003AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N201657-001AP1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1008-01ML - Milliliter0409-10083d95fa14-abee-45b6-aeed-e0403fdaa9ff12014-12-01
0409-1008-02ML - Milliliter0409-100841f0b9dd-db54-4fec-964a-b275f122bd5212014-12-01
0409-1008-11ML - Milliliter0409-100804c97227-bf3f-447f-b921-e3890d435b9d12014-12-01
0409-1008-12ML - Milliliter0409-1008b7bbd3e9-dd50-4286-879e-d25d8ca88f8e12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PARICALCITOLACTIVE INGREDIENT6702D36OG5PARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.]1
PARICALCITOLACTIVE MOIETY6702D36OG5PARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-1008-010040910080125 VIAL, MULTI-DOSE in 1 TRAY (0409-1008-01) > 1 mL in 1 VIAL, MULTI-DOSE (0409-1008-11) 2014-11-010000-00-00NoNoCurrent
0409-1008-020040910080225 VIAL, MULTI-DOSE in 1 TRAY (0409-1008-02) > 2 mL in 1 VIAL, MULTI-DOSE (0409-1008-12) 2014-11-010000-00-00NoNoCurrent