Calcitriol

Product NDC: 17856-3120
11-digit product format: 178563120
Labeler code: 17856
Product ID: 17856-3120_b5a67b79-b202-41fd-9dd4-f4fed74d3c8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcitriol
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA076242
Marketing category: ANDA
Marketing start: 2019-05-09
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: 2022-12-31
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	17856-3120		I	Inactivated by FDA		2026-08-10
excluded package	package	17856-3120	17856-3120-1	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 · 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
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	17856-3120-1	`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	17856-3120-1	`1332a3947898…`	`d4bfe170f9cd…`

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
A076242-001	CALCITRIOL	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA		2003-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076242-001	AA

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076242-001	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	2003-07-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A076242-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076242-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076242-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076242-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076242-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076242-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076242-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076242-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076242-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076242-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076242-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076242-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076242-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076242-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076242-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076242-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076242-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076242-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076242-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076242-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076242-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076242-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076242-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076242-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076242-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076242-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076242-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076242-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076242-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076242-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076242-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076242-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076242-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076242-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076242-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076242-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076242-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076242-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076242-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076242-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ef9a935e-31b7-402c-a66c-716cdfe4f126	Product name	9	20241218
09b728d3-9521-67a6-95fe-30969d1d5187	Product name	5	20240828
115c5bd2-98e1-4a98-8292-90803ca7e851	Product name	1	20220127
5f07db61-095c-acca-e8e9-d0916b4c1947	Product name	2	20200616
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
17856-3120-1	2024-05-20	C162847	48780-1	f386c64a-0fb0-0266-e053-dadaa90a7c1a	Calcitriol Oral Solution
17856-3120-1	2023-01-30	C162847	48780-1	f386c64a-0fb0-0266-e053-dadaa90a7c1a	Calcitriol Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-3120-1	Calcitriol	120 in 1 BOX, UNIT-DOSE	SOLUTION	120		3
17856-3120-1	Calcitriol	0.5 mL in 1 SYRINGE	SOLUTION	0.5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-3120	CALCITRIOL SOLUTION [ATLANTIC BIOLOGICALS CORP.]	3	Legacy NDC, 2 package rows	20240522_06e71c82-1383-44e8-bf96-e977633c72d7.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
Calcitriol	CALCITRIOL	Hikma Pharmaceuticals USA Inc.	3289b482-8733-484d-b1db-d7f4cdcd1ac2	2023-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076242 application number: ANDA076242

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
313932	calcitriol 1 MCG in 1 mL Oral Solution	PSN	06e71c82-1383-44e8-bf96-e977633c72d7	3
313932	calcitriol 0.001 MG/ML Oral Solution	SCD	06e71c82-1383-44e8-bf96-e977633c72d7	3
313932	calcitriol 1 MCG per 1 ML Oral Solution	SY	06e71c82-1383-44e8-bf96-e977633c72d7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-3120-1	17856312001	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-3120-1) > .5 mL in 1 SYRINGE	120 syringe	2021-01-26	0000-00-00	No	No	Current