Home NDC 0409-1007 Paricalcitol
Product NDC 0409-1007
11-digit product format 004091007
Labeler code 0409
Product ID 0409-1007_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 2014-12-01
Marketing end 0000-00-00
Substance PARICALCITOL
Active strength 2 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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0409-1007-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0409-1007-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-1007-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-1007-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-1007-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-1007-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-1007-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-1007-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-1007-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0409-1007-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0409-1007-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0409-1007-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201657-001 PARICALCITOL PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 N201657-002 PARICALCITOL PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 N201657-003 PARICALCITOL PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2014-10-21
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 2 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS 2014-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N201657-003 PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201657-001 PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N201657-002 PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP 2014-10-21 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PARICALCITOL ACTIVE INGREDIENT 6702D36OG5 PARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.] 1 PARICALCITOL ACTIVE MOIETY 6702D36OG5 PARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M PARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R PARICALCITOL INJECTION, SOLUTION [HOSPIRA, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0409-1007-01 00409100701 25 VIAL, MULTI-DOSE in 1 TRAY (0409-1007-01) > 1 mL in 1 VIAL, MULTI-DOSE (0409-1007-11) 2014-12-01 0000-00-00 No No Current