Home NDC 0074-9036 Zemplar
Product NDC 0074-9036
11-digit product format 000749036
Labeler code 0074
Product ID 0074-9036_ed8862d9-4037-4a30-9be6-42f2613c34cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paricalcitol
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler AbbVie Inc.
Application NDA021606
Marketing category NDA
Marketing start 2018-04-20
Marketing end 2027-03-31
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 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-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2005-05-26 N021606-003 ZEMPLAR PARICALCITOL 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26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N021606-003 ZEMPLAR 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2005-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021606-001 ZEMPLAR 1MCG CAPSULE / ORAL RLD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.
Additional Listing Data#
Finished product Yes
Brand name base Zemplar Active Ingredients# Ingredient, Strength table Ingredient Strength PARICALCITOL 1 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6702D36OG5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577315 Internal RxNorm lookup 577317 Internal RxNorm lookup 606854 Internal RxNorm lookup 606859 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0074-9036-30 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 0074-9036 ZEMPLAR (PARICALCITOL) CAPSULE, LIQUID FILLED [ABBVIE INC.] 1499 Current NDC, 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 Marketing start Marketing end Sample Exclude flag Status 0074-9036-30 00074903630 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-9036-30) 2018-04-20 0000-00-00 No No Current