Doxercalciferol

Product NDC: 71288-802
11-digit product format: 712880802
Labeler code: 71288
Product ID: 71288-802_76c7152a-bbff-478d-9a21-a67e1411c61b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxercalciferol
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA211670
Marketing category: ANDA
Marketing start: 2020-02-11
Substance: DOXERCALCIFEROL
Active strength: 4 ug/2mL
Pharmacologic classes: Ergocalciferols [CS], Vitamin D2 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71288-802	71288-802-03	D	Discontinued by firm		2026-08-07

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211670-001	DOXERCALCIFEROL	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RS	2020-02-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211670-001	AP

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.

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	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RS	2020-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP		2020-02-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211670-001	DOXERCALCIFEROL	4MCG/2ML (2MCG/ML)	INJECTABLE / INJECTION	AP	RS	2020-02-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211670-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211670-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211670-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211670-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211670-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211670-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211670-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211670-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211670-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211670-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211670-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211670-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211670-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211670-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211670-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211670-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211670-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211670-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211670-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211670-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211670-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211670-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211670-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211670-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211670-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211670-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211670-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211670-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211670-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211670-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211670-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211670-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211670-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211670-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211670-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211670-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211670-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxercalciferol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXERCALCIFEROL	4 ug/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3DIZ9LF5Y9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
282609	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
81a30e4b-be74-41d6-8277-b4f0ea5c15bc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
6d09ee63-cbd8-4742-9f11-2e20c9f8cd54	Product name	7	20240722
de957a3a-b26a-1797-ad5b-e5b01f363505	Product name	3	20210511
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71288-802-02	Doxercalciferol	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2	6
71288-802-03	Doxercalciferol	50 in 1 CARTON	INJECTION, SOLUTION	50	6
71288-802-04	Doxercalciferol	25 in 1 CARTON	INJECTION, SOLUTION	25	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-802-02	ML - Milliliter	71288-802	cba1437c-9bca-44f3-a0d1-f1943f906810	1	2020-07-13
71288-802-03	ML - Milliliter	71288-802	532fc6e1-832c-4c58-89fa-73710aa988bc	1	2020-07-13
71288-802-04	ML - Milliliter	71288-802	8f614fd2-f29e-4c60-8ba0-7eee16457786	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-802	DOXERCALCIFEROL INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 3 package rows	20240821_81a30e4b-be74-41d6-8277-b4f0ea5c15bc.zip

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
Doxercalciferol	DOXERCALCIFEROL	Meitheal Pharmaceuticals Inc.	81a30e4b-be74-41d6-8277-b4f0ea5c15bc	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211670 application number: ANDA211670 ndc (product): 71288-802

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
282609	doxercalciferol 2 MCG/ML Injectable Solution	PSN	81a30e4b-be74-41d6-8277-b4f0ea5c15bc	6
282609	doxercalciferol 0.002 MG/ML Injectable Solution	SCD	81a30e4b-be74-41d6-8277-b4f0ea5c15bc	6
282609	doxercalciferol 2 MCG/ML Injectable Solution	SY	81a30e4b-be74-41d6-8277-b4f0ea5c15bc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-802-02	71288080202	2 mL in 1 VIAL, MULTI-DOSE	2 ml					Historical
71288-802-03	71288080203	50 VIAL, MULTI-DOSE in 1 CARTON (71288-802-03) > 2 mL in 1 VIAL, MULTI-DOSE (71288-802-02)		2020-02-11	0000-00-00	No	No	Current
71288-802-04	71288080204	25 VIAL, MULTI-DOSE in 1 CARTON (71288-802-04) / 2 mL in 1 VIAL, MULTI-DOSE (71288-802-02)		2022-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxercalciferol	Meitheal Pharmaceuticals Inc. \| Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	6