Calcitriol

Product NDC: 43353-034
Requested package NDC: 43353-034-81
11-digit product format: 433530034
Labeler code: 43353
Product ID: 43353-034_d2e1ed0f-752a-4471-820d-291a99f751e6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcitriol
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076917
Marketing category: ANDA
Marketing start: 2006-03-27
Marketing end: 0000-00-00
Substance: CALCITRIOL
Active strength: 0 ug/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-034	43353-034-81	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 · 15 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A076917-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2006-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076917-001	AB

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	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076917-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2006-03-27	`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	A076917-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076917-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076917-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076917-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076917-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076917-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076917-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076917-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076917-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076917-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076917-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076917-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076917-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076917-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076917-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076917-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076917-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076917-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076917-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076917-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076917-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076917-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076917-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076917-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076917-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076917-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076917-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076917-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076917-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076917-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076917-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076917-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076917-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076917-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076917-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076917-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076917-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076917-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076917-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076917-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
09b728d3-9521-67a6-95fe-30969d1d5187	Product name	5	20240828
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
43353-034-09	2023-01-30	C162847	48780-1	f386c64a-1c08-0266-e053-dadaa90a7c1a	CALCITRIOL Capsules
43353-034-81	2023-01-30	C162847	48780-1	f386c64a-1c08-0266-e053-dadaa90a7c1a	CALCITRIOL Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-034-09	Calcitriol	9000 in 1 BOTTLE, PLASTIC	CAPSULE	9000		3
43353-034-81	Calcitriol	800 in 1 BOTTLE, PLASTIC	CAPSULE	800		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-034-09	EA - Each	43353-034	256537e6-9d41-4c8d-9434-3966a3fd581c	1	2014-05-02
43353-034-81	EA - Each	43353-034	7bd6dc6e-efff-4cb3-b544-02d001228c6d	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCITRIOL	ACTIVE INGREDIENT	FXC9231JVH	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CALCITRIOL	ACTIVE MOIETY	FXC9231JVH	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-034	CALCITRIOL CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 2 package rows	20191221_167a669f-7b7e-46ea-9331-567bf19d8787.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	Hikma Pharmaceuticals USA Inc.	cdcaffc6-e14e-4607-b77b-fc78a8382f60	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076917 application number: ANDA076917
Calcitriol	CALCITRIOL	PD-Rx Pharmaceuticals, Inc.	e1fcb1c7-11a9-4a23-a64a-2c8ce9698321	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076917 application number: ANDA076917
Calcitriol	CALCITRIOL	Aphena Pharma Solutions - Tennessee, LLC	adb1b2d5-33a7-4442-9074-cc1a89966528	2021-03-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076917 application number: ANDA076917

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
308867	calcitriol 0.25 MCG Oral Capsule	PSN	167a669f-7b7e-46ea-9331-567bf19d8787	3
308867	calcitriol 0.00025 MG Oral Capsule	SCD	167a669f-7b7e-46ea-9331-567bf19d8787	3
308867	calcitriol 0.25 MCG Oral Capsule	SY	167a669f-7b7e-46ea-9331-567bf19d8787	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-034-81	43353003481	800 CAPSULE in 1 BOTTLE, PLASTIC (43353-034-81)	800 capsule	2012-08-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CALCITRIOL Capsules	Aphena Pharma Solutions - Tennessee, LLC	2019-12-16	HUMAN PRESCRIPTION DRUG LABEL	3