Paricalcitol

Product NDC: 68382-330
11-digit product format: 683820330
Labeler code: 68382
Product ID: 68382-330_6dc3e89f-a1d9-481a-affa-801f55b28ba7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paricalcitol
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc
Application: NDA021606
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-04-20
Marketing end: 2023-08-17
Substance: PARICALCITOL
Active strength: 1 ug/1
Pharmacologic classes: Ergocalciferols [CS], Vitamin D2 Analog [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68382-330		D	Discontinued by firm		2026-08-17
excluded package	package	68382-330	68382-330-06	D	Discontinued by firm		2026-08-17

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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	68382-330-06	`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	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.

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68382-330-06	2020-08-19	C162847	48780-1	ab0e2407-2917-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use paricalcitol safely and effectively. See full prescribing information for paricalcitol. Paricalcitol capsules, for oral use Initial U.S. Approval: 1998
68382-330-06	2020-07-22	C162847	48780-1	ab0e2407-2917-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use paricalcitol safely and effectively. See full prescribing information for paricalcitol. Paricalcitol capsules, for oral use Initial U.S. Approval: 1998

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-330-06	EA - Each	68382-330	a037f71e-f354-478f-a844-a51d82f800a5	1	2018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PARICALCITOL	ACTIVE INGREDIENT	6702D36OG5	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
PARICALCITOL	ACTIVE MOIETY	6702D36OG5	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26
WATER	INACTIVE INGREDIENT	059QF0KO0R	PARICALCITOL CAPSULE, LIQUID FILLED [ZYDUS PHARMACEUTICALS USA INC]	26

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6702D36OG5	PARICALCITOL	131918-61-1	PARICALCITOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-330-06	68382033006	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (68382-330-06)	2018-04-20	0000-00-00	No	No	Current