Home NDC 0074-1658 Zemplar
Product NDC 0074-1658
11-digit product format 000741658
Labeler code 0074
Product ID 0074-1658_e3e59fde-f50f-49a4-8932-c1f53f579009
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Paricalcitol
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler AbbVie Inc.
Application NDA020819
Marketing category NDA
Marketing start 1998-04-17
Substance PARICALCITOL
Active strength 5 ug/mL
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 1 .
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 N020819-001 ZEMPLAR PARICALCITOL 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 N020819-002 ZEMPLAR PARICALCITOL 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 N020819-003 ZEMPLAR PARICALCITOL 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 123 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 2026-02-19 14:30 UTC 2026-02 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020819-002 ZEMPLAR 0.002MG/ML (0.002MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020819-003 ZEMPLAR 0.01MG/2ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020819-001 ZEMPLAR 0.005MG/ML (0.005MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 1998-04-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zemplar
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PARICALCITOL 5 ug/mL
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200321 Internal RxNorm lookup 213298 Internal RxNorm lookup 352076 Internal RxNorm lookup 1736919 Internal RxNorm lookup 1736921 Internal RxNorm lookup 1736931 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 0074-1658-01 Zemplar 25 in 1 TRAY INJECTION, SOLUTION 25 1482 0074-1658-01 Zemplar 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 1482 0074-1658-05 Zemplar 25 in 1 TRAY INJECTION, SOLUTION 25 1482 0074-1658-05 Zemplar 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 1482
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-1658 ZEMPLAR (PARICALCITOL) INJECTION, SOLUTION [ABBVIE INC.] 1481 Current NDC, Legacy NDC, 4 package rows 20240913_7259652f-81bc-4ad1-bba5-d01f9fac1b80.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 0074-1658-01 00074165801 25 VIAL, SINGLE-DOSE in 1 TRAY (0074-1658-01) / 1 mL in 1 VIAL, SINGLE-DOSE 1998-04-17 0000-00-00 No No Current 0074-1658-05 00074165805 25 VIAL, MULTI-DOSE in 1 TRAY (0074-1658-05) / 2 mL in 1 VIAL, MULTI-DOSE 1998-04-17 0000-00-00 No No Current