CALCITRIOL

Product NDC: 63304-241
Requested package NDC: 63304-241-59
11-digit product format: 633040241
Labeler code: 63304
Product ID: 63304-241_ccc0e02b-bd1e-45f2-9256-6933ac193518
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CALCITRIOL
Dosage form: SOLUTION
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA021068
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2009-08-26
Substance: CALCITRIOL
Active strength: 1 ug/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63304-241	63304-241-59	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021068-001	ROCALTROL	CALCITRIOL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021068-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021068-001	ROCALTROL	1MCG/ML	SOLUTION / ORAL	AA	RLD, RS	1998-11-20	`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	N021068-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021068-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021068-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021068-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021068-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021068-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021068-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021068-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021068-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021068-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021068-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021068-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021068-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021068-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021068-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021068-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021068-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021068-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021068-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021068-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021068-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021068-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021068-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021068-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021068-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021068-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021068-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021068-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021068-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021068-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021068-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021068-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021068-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021068-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021068-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021068-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021068-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021068-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021068-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021068-001	AA	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63304-241-59	CALCITRIOL	15 mL in 1 BOTTLE	SOLUTION	15		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-241-59	ML - Milliliter	63304-241	81889106-c659-4af1-9917-fed3b22cab40	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
63304-241	CALCITRIOL CAPSULE CALCITRIOL SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20180823_66a69351-5b09-4368-a9fa-acf81b5ad882.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calcitriol	CALCITRIOL	ANI Pharmaceuticals, Inc.	bdb9c0d4-bdb3-4174-a4d9-55c423f38476	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021068 application number: NDA021068

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
63304-241-59	63304024159	15 mL in 1 BOTTLE (63304-241-59)	15 ml	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