Application 021606

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEMPLAR	PARICALCITOL	CAPSULE;ORAL	1MCG	Yes	No
002	ZEMPLAR	PARICALCITOL	CAPSULE;ORAL	2MCG	Yes	No
003	ZEMPLAR	PARICALCITOL	CAPSULE;ORAL	4MCG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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	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N021606-003	ZEMPLAR	PARICALCITOL	4MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2005-05-26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 4 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
2022-10-28 04:53 UTC	2022-10	N021606-001	ZEMPLAR	1MCG	CAPSULE / ORAL	AB	RLD	2005-05-26	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021606-002	ZEMPLAR	2MCG	CAPSULE / ORAL	AB	RLD	2005-05-26	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021606-003	ZEMPLAR	4MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2005-05-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021606-001	ZEMPLAR	1MCG	CAPSULE / ORAL	AB	RLD	2005-05-26	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021606-002	ZEMPLAR	2MCG	CAPSULE / ORAL	AB	RLD	2005-05-26	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021606-003	ZEMPLAR	4MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2005-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021606-001	ZEMPLAR	1MCG	CAPSULE / ORAL	AB	RLD	2005-05-26	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021606-002	ZEMPLAR	2MCG	CAPSULE / ORAL	AB	RLD	2005-05-26	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	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	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021606-001	ZEMPLAR	1MCG	CAPSULE / ORAL		RLD	2005-05-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021606-002	ZEMPLAR	2MCG	CAPSULE / ORAL		RLD	2005-05-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	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	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021606-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021606-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021606-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021606-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021606-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021606-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021606-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021606-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021606-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021606-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021606-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021606-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021606-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021606-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021606-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021606-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021606-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021606-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021606-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021606-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021606-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021606-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021606-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021606-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021606-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021606-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021606-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021606-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021606-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021606-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021606-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021606-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021606-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021606-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021606-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021606-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021606-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021606-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021606-002	AB	1	`87673890dc5c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021606-001	ODE-125	2023-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021606-002	ODE-125	2023-10-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021606-003	ODE-125	2023-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021606-001	ODE-125	2023-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021606-002	ODE-125	2023-10-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021606-003	ODE-125	2023-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021606-001	ODE-125	2023-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021606-002	ODE-125	2023-10-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021606-003	ODE-125	2023-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021606-001	NPP	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-001	NPP	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-001	ODE-125	2023-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-002	NPP	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-002	NPP	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-002	ODE-125	2023-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-003	NPP	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-003	NPP	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021606-003	ODE-125	2023-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021606-001	ODE-125	2023-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021606-002	ODE-125	2023-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021606-003	ODE-125	2023-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021606-001	ODE-125	2023-10-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021606-002	ODE-125	2023-10-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021606-003	ODE-125	2023-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021606-001	ODE-125	2023-10-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021606-002	ODE-125	2023-10-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021606-003	ODE-125	2023-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021606-001	ODE-125	2023-10-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021606-002	ODE-125	2023-10-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021606-003	ODE-125	2023-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021606-001	ODE-125	2023-10-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021606-002	ODE-125	2023-10-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021606-003	ODE-125	2023-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021606-001	ODE-125	2023-10-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021606-002	ODE-125	2023-10-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021606-003	ODE-125	2023-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021606-001	NPP	2019-10-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021606-001	NPP	2019-10-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021606-001	ODE-125	2023-10-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021606-002	NPP	2019-10-18	`3f01610625f2…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zemplar	PARICALCITOL	AbbVie Inc.	1b27c026-2d60-47b4-2a9c-ded1818f21b5	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021606 application number: NDA021606 ndc (product): 0074-9036 ndc (product): 0074-9037 ndc (product): 0074-4314

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-4314	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-4314	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-4314	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9036	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9036	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9036	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9036	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9036	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9036	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9036	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9037	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9037	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9037	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9037	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9037	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9037	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
0074-9037	Zemplar	Paricalcitol	AbbVie Inc.	NDA	Current
68382-266	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-266	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-267	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-267	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-330	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-330	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-330	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-330	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-330	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-331	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-331	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-331	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-331	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current
68382-331	Paricalcitol	Paricalcitol	Zydus Pharmaceuticals USA Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47276	SUPPL	2017-02-22
47275	SUPPL	2017-02-22
45564	SUPPL	2016-10-20
45563	SUPPL	2016-10-20
37332	SUPPL	2014-09-03
28238	SUPPL	2014-09-03
15865	SUPPL	2014-09-03
5840	SUPPL	2014-09-03
5838	SUPPL	2011-04-19
5839	SUPPL	2011-04-11
15864	SUPPL	2011-04-07
5837	SUPPL	2010-06-15
37331	SUPPL	2010-06-14
5836	SUPPL	2009-07-07
37330	SUPPL	2009-07-02
21757	ORIG	2007-01-26
28237	ORIG	2005-05-27
15863	ORIG	2005-05-27
51552	ORIG	1900-01-01
51551	ORIG	1900-01-01
51550	ORIG	1900-01-01
51549	ORIG	1900-01-01