Calcitriol

Product NDC: 71610-468
11-digit product format: 716100468
Labeler code: 71610
Product ID: 71610-468_e4a50edb-a1aa-436f-9379-63010ae70dae
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: 2013-05-24
Substance: CALCITRIOL
Active strength: .25 ug/1
Pharmacologic classes: Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091174-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	2013-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091174-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	2013-05-24	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091174-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091174-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091174-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091174-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CALCITRIOL	.25 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FXC9231JVH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308867	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
3c40c40c-1627-4bcd-ba35-bee9b952d985	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
09b728d3-9521-67a6-95fe-30969d1d5187	Product name	5	20240828
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
5f07db61-095c-acca-e8e9-d0916b4c1947	Product name	2	20200616
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
98f556da-44be-c658-496e-47884da4e67b	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-468-09	Calcitriol	9000 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	9000		2
71610-468-30	Calcitriol	30 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-468-30	EA - Each	71610-468	3d18d83a-eec8-49e7-8b64-ea3d9a541d16	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-468	CALCITRIOL CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20230615_3c40c40c-1627-4bcd-ba35-bee9b952d985.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 ndc (product): 71610-468

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	3c40c40c-1627-4bcd-ba35-bee9b952d985	2
308867	calcitriol 0.00025 MG Oral Capsule	SCD	3c40c40c-1627-4bcd-ba35-bee9b952d985	2
308867	calcitriol 0.25 MCG Oral Capsule	SY	3c40c40c-1627-4bcd-ba35-bee9b952d985	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-468-09	71610046809	9000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-09)	2020-09-21	0000-00-00	No	No	Current
71610-468-30	71610046830	30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71610-468-30)	2023-06-12		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	2023-06-13	HUMAN PRESCRIPTION DRUG LABEL	2