Hectorol

Product NDC: 58468-0127
11-digit product format: 584680127
Labeler code: 58468
Product ID: 58468-0127_b646a8df-8c49-495a-be37-c842231a167c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DOXERCALCIFEROL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Genzyme Corporation
Application: NDA021027
Marketing category: NDA
Marketing start: 2008-12-08
Marketing end: 0000-00-00
Substance: DOXERCALCIFEROL
Active strength: 4 ug/2mL
Pharmacologic classes: Ergocalciferols [CS], Vitamin D2 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
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	58468-0127		D	Discontinued by firm		2026-10-16
excluded package	package	58468-0127	58468-0127-1	D	Discontinued by firm		2026-10-16

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58468-0127-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58468-0127-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58468-0127-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021027-001	HECTOROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06
N021027-002	HECTOROL	DOXERCALCIFEROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06

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 3 · 88 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
2026-10-15 13:18:30	2026-09	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION		RLD	2000-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021027-001	HECTOROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD, RS	2000-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021027-002	HECTOROL	2MCG/ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RLD	2000-04-06	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	N021027-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021027-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021027-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021027-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021027-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021027-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021027-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021027-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021027-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021027-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021027-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021027-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021027-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021027-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021027-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021027-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021027-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021027-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021027-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021027-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021027-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021027-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021027-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021027-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021027-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021027-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021027-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021027-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021027-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021027-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021027-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021027-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021027-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021027-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021027-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021027-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021027-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021027-002	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58468-0127-1	2023-01-06	C162847	48780-1	e4f33bdf-a8cf-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use HECTOROL safely and effectively. See full prescribing information for HECTOROL. HECTOROL ® (doxercalciferol) capsules, for oral use HECTOROL ® (doxercalciferol) injection, for intravenous use Initial U.S. Approval: 1999
58468-0127-1	2022-07-29	C162847	48780-1	e4f33bdf-a8cf-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use HECTOROL safely and effectively. See full prescribing information for HECTOROL. HECTOROL ® (doxercalciferol) capsules, for oral use HECTOROL ® (doxercalciferol) injection, for intravenous use Initial U.S. Approval: 1999

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58468-0127-0	ML - Milliliter	58468-0127	ff07c016-2f02-4e21-8562-065c52abf2e6	1	2021-05-05
58468-0127-1	ML - Milliliter	58468-0127	3c3534f8-ed29-44c9-954d-3d652f2ebfdd	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOXERCALCIFEROL	ACTIVE INGREDIENT	3DIZ9LF5Y9	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7
DOXERCALCIFEROL	ACTIVE MOIETY	3DIZ9LF5Y9	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INACTIVE INGREDIENT	70WT22SF4B	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58468-0127	HECTOROL (DOXERCALCIFEROL) INJECTION, SOLUTION [GENZYME CORPORATION]	15	Legacy NDC	20230429_7efc3d9c-12f5-43f6-9a22-88d66cbe6f62.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3DIZ9LF5Y9	DOXERCALCIFEROL	54573-75-0	DOXERCALCIFEROL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58468-0127-1	58468012701	50 VIAL, MULTI-DOSE in 1 BOX (58468-0127-1) > 2 mL in 1 VIAL, MULTI-DOSE (58468-0127-0)	2008-12-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hectorol	Genzyme Corporation \| Assia Chemical Industries Ltd. - Teva Tech Site	2025-06-16	HUMAN PRESCRIPTION DRUG LABEL	16