Home Applications 020819 Application 020819
Type NDA
Sponsor ABBVIE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.005MG/ML (0.005MG/ML) Yes Yes 002 ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.002MG/ML (0.002MG/ML) Yes Yes 003 ZEMPLAR PARICALCITOL SOLUTION;INTRAVENOUS 0.01MG/2ML (0.005MG/ML) Yes 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.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0074-1658 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-1658 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-1658 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-1658 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-1658 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-1658 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-1658 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-4637 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-4637 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-4637 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-4637 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-4637 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-4637 Zemplar Paricalcitol AbbVie Inc. NDA Current 0074-4637 Zemplar Paricalcitol AbbVie Inc. NDA Current