Calcitriol

Product NDC: 43353-998
11-digit product format: 433530998
Labeler code: 43353
Product ID: 43353-998_9bef390d-c6c4-4961-b030-0da3aa5a106a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcitriol
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA091174
Marketing category: ANDA
Marketing start: 2013-05-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43353-998		D	Discontinued by firm		2026-08-10
excluded package	package	43353-998	43353-998-09	D	Discontinued by firm		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
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	43353-998-09	`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	43353-998-09	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A091174-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2013-05-24
A091174-002	CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2013-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091174-001	AB
A091174-002	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 3 · 82 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	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091174-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091174-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091174-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091174-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091174-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091174-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091174-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091174-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091174-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091174-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091174-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091174-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091174-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091174-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091174-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091174-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091174-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091174-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091174-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091174-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091174-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091174-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091174-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091174-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091174-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091174-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091174-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091174-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091174-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091174-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091174-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091174-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091174-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-998-09	EA - Each	43353-998	defce580-0e32-4c69-a52b-de4f57d834f6	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-998	CALCITRIOL CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20160706_81f14b75-2edb-45b4-82e2-47c8ef2c7a2e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	Bryant Ranch Prepack	bf621b22-b783-416f-aee3-e0dbfdb782ca	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174
Calcitriol	CALCITRIOL	Golden State Medical Supply, Inc.	8465337c-86ca-ea9d-e053-2991aa0ab167	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174
Calcitriol	CALCITRIOL	BIONPHARMA INC.	626f23d5-31e6-41ca-a696-191a4f2bc7ef	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174
Calcitriol	CALCITRIOL	A-S Medication Solutions	b57feb9f-2c5c-4d1c-9330-09c6e9fed95c	2023-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174
Calcitriol	CALCITRIOL	Aphena Pharma Solutions - Tennessee, LLC	3c40c40c-1627-4bcd-ba35-bee9b952d985	2023-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091174 application number: ANDA091174

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-998-09	43353099809	9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-998-09)	2015-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calcitriol capsule, Liquid Filled Rx only	Aphena Pharma Solutions - Tennessee, LLC	2016-06-13	HUMAN PRESCRIPTION DRUG LABEL	1