Paricalcitol

Product NDC: 43598-563
11-digit product format: 435980563
Labeler code: 43598
Product ID: 43598-563_8f09ecf2-4018-c4d9-2a67-b797baf3c742
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paricalcitol
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Dr. Reddy's Laboratories, Inc.
Application: ANDA204910
Marketing category: ANDA
Marketing start: 2016-09-06
Marketing end: 0000-00-00
Substance: PARICALCITOL
Active strength: 2 ug/mL
Pharmacologic classes: Cholecalciferol [CS],Vitamin D3 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	43598-563		D	Discontinued by firm		2026-10-15
excluded package	package	43598-563	43598-563-25	D	Discontinued by firm		2026-10-15

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 · 4 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	43598-563-25	`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	43598-563-25	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	Approval date
A204910-001	PARICALCITOL	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	2016-08-17
A204910-002	PARICALCITOL	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	2016-08-17
A204910-003	PARICALCITOL	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	2016-08-17

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS		2016-08-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204910-002	PARICALCITOL	0.005MG/ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204910-003	PARICALCITOL	0.01MG/2ML (0.005MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204910-001	PARICALCITOL	0.002MG/ML (0.002MG/ML)	SOLUTION / INTRAVENOUS	AP	2016-08-17	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A204910-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204910-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204910-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204910-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204910-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204910-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204910-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204910-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204910-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204910-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204910-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204910-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204910-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204910-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204910-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204910-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204910-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204910-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204910-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204910-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204910-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204910-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204910-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204910-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204910-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204910-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204910-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204910-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204910-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204910-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204910-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204910-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204910-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204910-002	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204910-003	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204910-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204910-002	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204910-003	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204910-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204910-002	AP	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-563-11	ML - Milliliter	43598-563	44fe904b-74dc-4a4e-a454-37dbd35e2d62	1	2016-10-06
43598-563-25	ML - Milliliter	43598-563	f878ed5e-1603-47ac-9a66-6838bc2d7435	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-563	PARICALCITOL INJECTION, SOLUTION [DR. REDDY'S LABORATORIES, INC.]	4	Legacy NDC	20190618_07e49b4e-5a6d-66aa-97c8-7ca582d44771.zip

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
43598-563-25	43598056325	25 VIAL, SINGLE-DOSE in 1 CARTON (43598-563-25) > 1 mL in 1 VIAL, SINGLE-DOSE (43598-563-11)	2016-09-06	0000-00-00	No	No	Current