Home NDC 0074-4314 Zemplar
Product NDC 0074-4314
11-digit product format 000744314
Labeler code 0074
Product ID 0074-4314_df7af46c-1f04-d38e-bd8c-3d55b61a8b1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paricalcitol
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler AbbVie Inc.
Application NDA021606
Marketing category NDA
Marketing start 2010-06-14
Marketing end 2019-12-30
Substance PARICALCITOL
Active strength 2 ug/1
Pharmacologic classes Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 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 0074-4314-30 557ba5c1ecfa…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021606-001 ZEMPLAR PARICALCITOL 1MCG CAPSULE / ORAL RLD 2005-05-26 N021606-002 ZEMPLAR PARICALCITOL 2MCG CAPSULE / ORAL RLD 2005-05-26 N021606-003 ZEMPLAR PARICALCITOL 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL RLD 2005-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL RLD 2005-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL RLD 2005-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL RLD 2005-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021606-002 ZEMPLAR 2MCG CAPSULE / ORAL AB RLD 2005-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL AB RLD 2005-05-26 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 96 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0074-4314-30 Zemplar 30 in 1 BOTTLE CAPSULE, LIQUID FILLED 30 1500
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PARICALCITOL ACTIVE INGREDIENT 6702D36OG5 ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 PARICALCITOL ACTIVE MOIETY 6702D36OG5 ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 GELATIN INACTIVE INGREDIENT 2G86QN327L ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438 WATER INACTIVE INGREDIENT 059QF0KO0R ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1438
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-4314 ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1499 Legacy NDC, 1 package rows 20240808_1b27c026-2d60-47b4-2a9c-ded1818f21b5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 0074-4314-30 00074431430 30 in 1 BOTTLE Historical