Calcitriol

Product NDC: 63629-7323
Requested package NDC: 63629-7323-1
11-digit product format: 636297323
Labeler code: 63629
Product ID: 63629-7323_b5ca1280-996e-43d2-8e9a-657c0e9a4600
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Calcitriol Capsules 0.25 mcg
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091356
Marketing category: ANDA
Marketing start: 2014-12-12
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

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-7323	63629-7323-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A091356-001	CALCITRIOL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12
A091356-002	CALCITRIOL	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091356-001	AB
A091356-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RS	2014-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091356-001	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB		2014-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091356-002	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB		2014-12-12	`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	A091356-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091356-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091356-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091356-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091356-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091356-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091356-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091356-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091356-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091356-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091356-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091356-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091356-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091356-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091356-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091356-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091356-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091356-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091356-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091356-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091356-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091356-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091356-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091356-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091356-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091356-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091356-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091356-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091356-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091356-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091356-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091356-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091356-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091356-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091356-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091356-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091356-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091356-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091356-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091356-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308867	Internal RxNorm lookup
308868	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
3637da5e-55cf-40ed-9bea-18c27b595627	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
5f07db61-095c-acca-e8e9-d0916b4c1947	Product name	2	20200616
98f556da-44be-c658-496e-47884da4e67b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-7323-1	Calcitriol	30 in 1 BOTTLE	CAPSULE	30	9
63629-7323-2	Calcitriol	28 in 1 BOTTLE	CAPSULE	28	9
63629-7323-3	Calcitriol	90 in 1 BOTTLE	CAPSULE	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-7323-1	EA - Each	63629-7323	99304b41-2571-4cc1-91b5-1ab2fc611514	1	2017-12-14
63629-7323-2	EA - Each	63629-7323	827c805c-df4b-42f7-91da-fb054913edc1	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-7323	CALCITRIOL (CALCITRIOL CAPSULES 0.5 MCG) CAPSULE CALCITRIOL (CALCITRIOL CAPSULES 0.25 MCG) CAPSULE [BRYANT RANCH PREPACK]	9	Current NDC, 3 package rows	20240711_3637da5e-55cf-40ed-9bea-18c27b595627.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Strides Pharma Science Limited	bebefb2a-7365-48e2-9681-83ed4b41e26e	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Cardinal Health 107, LLC	32205cfc-7939-4105-a4b9-2ed327c5e0cc	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
Calcitriol	CALCITRIOL	Chartwell RX, LLC	36820cd0-7b30-4454-9005-09d71e1d5796	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	American Health Packaging	261398eb-80b8-4c3d-9d2b-3a8004347a75	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
CALCITRIOL	CALCITRIOL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	2b48f57a-c023-485d-b846-cab3aaaad486	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Aphena Pharma Solutions - Tennessee, LLC	29b8cc1f-0491-0a95-e063-6294a90a223d	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
CALCITRIOL	CALCITRIOL	A-S Medication Solutions	26ac6b4d-9576-4710-856b-aca114ea84cf	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356
Calcitriol	CALCITRIOL CAPSULES 0.25 MCG	Bryant Ranch Prepack	3637da5e-55cf-40ed-9bea-18c27b595627	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091356 application number: ANDA091356 ndc (package): 63629-7323-1 ndc (product): 63629-7323 ndc11 (package): 63629732301

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	3637da5e-55cf-40ed-9bea-18c27b595627	9
308868	calcitriol 0.5 MCG Oral Capsule	PSN	3637da5e-55cf-40ed-9bea-18c27b595627	9
308867	calcitriol 0.00025 MG Oral Capsule	SCD	3637da5e-55cf-40ed-9bea-18c27b595627	9
308868	calcitriol 0.0005 MG Oral Capsule	SCD	3637da5e-55cf-40ed-9bea-18c27b595627	9
308867	calcitriol 0.25 MCG Oral Capsule	SY	3637da5e-55cf-40ed-9bea-18c27b595627	9
308868	calcitriol 0.5 MCG Oral Capsule	SY	3637da5e-55cf-40ed-9bea-18c27b595627	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63629-7323-1	63629732301	30 CAPSULE in 1 BOTTLE (63629-7323-1)	30 capsule	2018-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calcitriol Capsules (0.25 mcg & 0.5 mcg)	Bryant Ranch Prepack	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	9