Calcitriol

Product NDC: 17478-831
11-digit product format: 174780831
Labeler code: 17478
Product ID: 17478-831_c530bfdb-720f-4a88-88dd-af2bf93798b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcitriol
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Akorn
Application: ANDA078066
Marketing category: ANDA
Marketing start: 2013-03-22
Marketing end: 0000-00-00
Substance: CALCITRIOL
Active strength: 1 ug/mL
Pharmacologic classes: Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	17478-831		I	Inactivated by FDA		2026-08-10
excluded package	package	17478-831	17478-831-01	I	Inactivated by FDA		2026-08-10

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 · 30 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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`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	17478-831-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-831-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-831-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-831-01	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A078066-001	CALCITRIOL	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29
A078066-002	CALCITRIOL	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078066-001	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.

Product history page 1 of 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION		RS	2008-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078066-001	CALCITRIOL	0.001MG/ML	INJECTABLE / INJECTION	AP	RS	2008-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078066-002	CALCITRIOL	0.002MG/ML	INJECTABLE / INJECTION			2008-01-29	`782e0a99824c…`

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	A078066-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078066-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078066-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078066-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078066-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078066-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078066-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078066-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078066-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078066-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078066-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078066-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078066-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078066-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078066-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078066-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078066-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A078066-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078066-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078066-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078066-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078066-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078066-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078066-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078066-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078066-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078066-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078066-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078066-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078066-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078066-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078066-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078066-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078066-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078066-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078066-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078066-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
09b728d3-9521-67a6-95fe-30969d1d5187	Product name	5	20240828
5f07db61-095c-acca-e8e9-d0916b4c1947	Product name	2	20200616
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
98f556da-44be-c658-496e-47884da4e67b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-831-01	2024-01-30	C162847	48780-1	1030e365-33a7-111a-e063-dadaa90a10e2	CALCITRIOL INJECTION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-831-01	Calcitriol	1 mL in 1 AMPULE	INJECTION	1		6
17478-831-01	Calcitriol	10 in 1 CARTON	INJECTION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-831-01	ML - Milliliter	17478-831	b0369ef5-c8a2-4e2f-a6a5-43e27d8d265d	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Calcitriol	ACTIVE INGREDIENT	FXC9231JVH	CALCITRIOL INJECTION [AKORN, INC.]	2
Calcitriol	ACTIVE MOIETY	FXC9231JVH	CALCITRIOL INJECTION [AKORN, INC.]	2
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	CALCITRIOL INJECTION [AKORN, INC.]	2
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	CALCITRIOL INJECTION [AKORN, INC.]	2
Sodium Ascorbate	INACTIVE INGREDIENT	S033EH8359	CALCITRIOL INJECTION [AKORN, INC.]	2
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	CALCITRIOL INJECTION [AKORN, INC.]	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	CALCITRIOL INJECTION [AKORN, INC.]	2
Sodium Phosphate, Monobasic, Monohydrate	INACTIVE INGREDIENT	593YOG76RN	CALCITRIOL INJECTION [AKORN, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	CALCITRIOL INJECTION [AKORN, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-831	CALCITRIOL INJECTION [AKORN]	6	Legacy NDC, 2 package rows	20220913_f3b180dd-6c0b-4c15-85d3-bbbb5176d1d1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FXC9231JVH	CALCITRIOL	32222-06-3	CALCITRIOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308869	calcitriol 1 MCG in 1 ML Injection	PSN	f3b180dd-6c0b-4c15-85d3-bbbb5176d1d1	6
308869	1 ML calcitriol 0.001 MG/ML Injection	SCD	f3b180dd-6c0b-4c15-85d3-bbbb5176d1d1	6
308869	calcitriol 1 MCG per 1 ML Injection	SY	f3b180dd-6c0b-4c15-85d3-bbbb5176d1d1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-831-01	17478083101	10 AMPULE in 1 CARTON (17478-831-01) > 1 mL in 1 AMPULE	10 ampule	2013-03-22	0000-00-00	No	No	Current