CALCITRIOL

Product NDC: 63304-240
11-digit product format: 633040240
Labeler code: 63304
Product ID: 63304-240_ccc0e02b-bd1e-45f2-9256-6933ac193518
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CALCITRIOL
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA018044
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-08-26
Substance: CALCITRIOL
Active strength: .5 ug/1
Pharmacologic classes: Cholecalciferol [CS], Vitamin D3 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	63304-240		I	Inactivated by FDA		2026-08-10
excluded package	package	63304-240	63304-240-01	I	Inactivated by FDA		2026-08-10

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
N018044-001	ROCALTROL	CALCITRIOL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N018044-002	ROCALTROL	CALCITRIOL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018044-001	AB
N018044-002	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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018044-001	ROCALTROL	0.25MCG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018044-002	ROCALTROL	0.5MCG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`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	N018044-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018044-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018044-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018044-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018044-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018044-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018044-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018044-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018044-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018044-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018044-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018044-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018044-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018044-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018044-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018044-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018044-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018044-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018044-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018044-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018044-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018044-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018044-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018044-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018044-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018044-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018044-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018044-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018044-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018044-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018044-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018044-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018044-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018044-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018044-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018044-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018044-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018044-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018044-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018044-002	AB	1	`782e0a99824c…`

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	Strength	SPL version
63304-240-01	CALCITRIOL	100 in 1 BOTTLE	CAPSULE	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-240-01	EA - Each	63304-240	58e4925e-227a-4e87-b40f-6328eda48b24	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCITRIOL	ACTIVE INGREDIENT	FXC9231JVH	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
CALCITRIOL	ACTIVE MOIETY	FXC9231JVH	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
PALM OIL	INACTIVE INGREDIENT	5QUO05548Z	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [RANBAXY PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-240	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20180823_66a69351-5b09-4368-a9fa-acf81b5ad882.zip

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	66a69351-5b09-4368-a9fa-acf81b5ad882	4
308868	calcitriol 0.5 MCG Oral Capsule	PSN	66a69351-5b09-4368-a9fa-acf81b5ad882	4
313932	calcitriol 1 MCG in 1 mL Oral Solution	PSN	66a69351-5b09-4368-a9fa-acf81b5ad882	4
308867	calcitriol 0.00025 MG Oral Capsule	SCD	66a69351-5b09-4368-a9fa-acf81b5ad882	4
308868	calcitriol 0.0005 MG Oral Capsule	SCD	66a69351-5b09-4368-a9fa-acf81b5ad882	4
313932	calcitriol 0.001 MG/ML Oral Solution	SCD	66a69351-5b09-4368-a9fa-acf81b5ad882	4
308867	calcitriol 0.25 MCG Oral Capsule	SY	66a69351-5b09-4368-a9fa-acf81b5ad882	4
308868	calcitriol 0.5 MCG Oral Capsule	SY	66a69351-5b09-4368-a9fa-acf81b5ad882	4
313932	calcitriol 1 MCG per 1 ML Oral Solution	SY	66a69351-5b09-4368-a9fa-acf81b5ad882	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-240-01	63304024001	100 CAPSULE in 1 BOTTLE (63304-240-01)	100 capsule	2009-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CALCITRIOL CAPSULES and ORAL SOLUTION Rx only	Sun Pharmaceutical Industries, Inc. \| Validus Pharmaceuticals LLC \| Catalent Pharma Solutions \| Lyne Laboratories	2018-08-22	HUMAN PRESCRIPTION DRUG LABEL	4